Edinburgh Royal Infirmary Renal Unit

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This page was last modified on 03/12/2009 at 10:14.

Referral

For East of Scotland patients:

A referral letter with a transplant recipient check-list and summary (appendix I) should be sent to the Transplant Unit (addressed to Mr J Forsythe; Mr M Akyol; or Mr J Casey, Consultant Transplant Surgeons). All referred patients will be sent an appointment. Lothian, Borders and Fife patients are seen at the transplant assessment clinic in Edinburgh, others are seen in regional units. Patients are seen by a transplant surgeon and recipient transplant co-ordinator. If indicated further assessment by an anaesthetist, psychologist (Appendix III) dentist, dietitian, dermatologist or any other relevant specialist may be sought.

Work up for renal transplantation should be carried out at the local centre. Patients will have the opportunity for detailed discussion regarding kidney transplantation and will be counselled with respect to relative risks and benefits of cadaveric and living donor kidney transplantation. An information booklet is also given to the patient to support the verbal information given at the assessment clinic.

All patients who are referred for renal transplantation should have risk factors assessed and further screening requested as per Appendix II.

Listing

Following initial outpatient assessment, those patients who are considered potentially suitable candidates and who remain willing to be considered for a transplant will undergo further investigation as required. The transplant coordinator will arrange for copies of all the required investigations prior to listing. When investigations are complete, the transplant team will review the results. Further investigations and/or treatments may be required at this time. The decision about listing the candidate for kidney transplantation will be made by the transplant surgeons after discussion with the multi-disciplinary team and the patient. A detailed letter regarding the patient assessment will be sent to the referring centre with a copy to the general practitioner. If the patient is to be listed, the patient will be directly informed, verbally and in writing, by the transplant co-ordinator. All patients have the opportunity to be seen for a repeat appointment in clinic before listing. UKT will be informed by the transplant co-ordinator as per unit procedure.

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(no previous) >> Kidney offer

This page last modified 03.12.2009 10:14 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Protocols on this page concern Edinburgh management of deceased donor kidneys.

Local donation Deceased donor after brain death (DBD) Deceased donor non-heart-beating (NHBD)

Local donor procedure

Tissue type to be established as soon as possible, usually from peripheral blood lymphocytes (see appendix IV). UKT will inform the donor transplant co-ordinator of the allocation of the kidneys as per National allocation schemes so that the kidneys can be packed and addressed to the appropriate centre. UKT or the donor recipient co-ordinator will then contact the local renal recipient transplant co-ordinator with a kidney or kidney/pancreas offer if appropriate.

Offers from Deceased Donors after Brain Death (DBD) (heart beating donors)

The on-call renal recipient transplant co-ordinator will receive the offer of a kidney from UKT. Transplant co-ordinator contacts transplant surgeon and asks for a decision as to whether the kidney should be accepted. If the decision has been made to go ahead, then the transplant co-ordinator contacts the patients own local Consultant Nephrologist and the RIE on call Consultant nephrologist, to ensure that the patient is fit and should be called.

Donation after cardiac death (non-heart beating donors)

NB: Because of difficulties of getting local match run to H&I/coordinators from West of Scotland donors (i.e. those typed in GG&C H&I, Gartnavel Hospital) this revision to allocation will initially be for East of Scotland donors only. Patients for West of Scotland donors will be selected as currently.

East of Scotland donors: After receipt of the UKT ‘local’ allocation match run a patient is selected for XM, prioritised as follows:

000 matched patient, or the longest waiting patient in match Levels 2/3 with a current (<3/12) serum sample available who has had no sensitising events since the last sample. If the longest waiting patient is not suitable/available then the next longest waiting patient will be selected, etc

Two backup patients will also be selected working down from the top of the match run list who are HLA antibody negative with current (<3/12) sample available.

West of Scotland donors: Patients for crossmatch are selected according to the UKT ‘local’ allocation match run. The patient at the top of the run is selected for crossmatch. The reasons for any deviation from this selection must be clearly explained to the coordinator. As the kidney is to remain locally back up patient(s) may be selected for XM in consultation with the local coordinators.

Allocation of DCD will be jointly audited by H&I and recipient coordinators and will record how often the above policy was adhered to, reasons for deviations from this policy and the individual making the decision to deviate from the policy.

Transplant co-ordinator performs the following tasks: Contact of the patient. Arrangement of transport for the patient and his/her notes to the renal transplant unit. NB: APD patients to bring own machine. Alert renal transplant unit and give details of patient and dialysis needs. Alert the renal registrar with the patient details. Alert Hospital at Night to clerk patient or any other specific requests. Alert the tissue typist with the patient details. It is the responsibility of the transplant co-ordinator to organise theatre. Informing the anaesthetist and on call theatre person to book the first available operating space. It is the responsibility of the renal registrar, and the on call consultant nephrologist to ensure the chosen patient is adequately dialysed and medically fit prior to operation. The on-call renal reg or HAN also liases with BTS regarding grouping and saving.

Fife, Dundee, Aberdeen and Inverness patient arrangements:

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Transplant co-ordinator will discuss the patient with the surgeon and patient’s local nephrologist. If the kidney is to be accepted, the transplant co-ordinator will also inform the RIE consultant nephrologist on-call.

The nephrologist or the transplant co-ordinator to contact the patient. The renal recipient transplant co-ordinator arranges transport of the patient to the RIE.

The transplant co-ordinator or local nephrologist arranges the patient’s notes to be sent to the transplant unit ASAP.

If the patient requires dialysis this is to be organised in Edinburgh. The MRSA and virology status of the patient must be known.

Otherwise as above.

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Patient Assessment << >> Risk Factors for Graft Dysfunction

This page last modified 25.01.2011 10:09 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Several risk factors for graft failure or dysfunction can be identified prior to surgery. These include:

HLA mismatch - non favourable ie DR mismatches Preformed antibodies to HLA or a panel reactivity of 50-100% Number of previous transplants The presence of delayed graft function (the requirement for dialysis during the first week after transplant except for hyperkalaemia). The number of rejection episodes / severity of rejection episodes Donor age Ischaemic time

Management

Taking the above factors into account, patients who are at greater risk of graft failure may be identified and in some cases used to influence the decision to go ahead, or to vary immunosuppression or other therapy.

e.g. plasma exchange and other treatment options may be considered if there are high titres of preformed HLA Antibodies.

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Kidney offer << >> When the Kidney arrives

This page last modified 03.12.2009 10:22 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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(specific Edinburgh protocols on this page)

In Edinburgh the kidney will arrive at the Transplant Unit HDU Ward 117. Renal Recipient Transplant co-ordinator to give approximate arrival time of kidney. If the kidney has not arrived within 30 minutes of this time please contact renal recipient transplant co-ordinator.

Check that the kidney is surrounded by sufficient ice, and top up if not. (Responsibility of Ward 117 Nursing staff).

Send spleen and lymph nodes to BTS for urgent lymphocytotoxic crossmatch. Please ensure that a SNBTS histocompatibility platelet immuno-haematology form is completed and sent to tissue-typing with the lymph node and spleen.

Note:

Two kidneys may arrive in Unit if the kidneys are from a local donor. These kidneys will be allocated according to UKT and may need to be sent to another centre. For kidney allocation rules please see UK Transplant web site at - www.uktransplant.org In this case the box containing the kidney to be sent outwith the unit should not be disturbed, it will be picked up by the courier service as arranged by UKT. UKT will inform the transplant unit where the kidney is going to. Transplant unit to clearly write name and address of where the kidney is going. Check with UKT whether it is right or left kidney if in any doubt contact donor transplant co-ordinator.

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Risk Factors for Graft Dysfunction << >> Pre-Op Recipient

This page last modified 03.09.2009 13:56 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Patient

Ensure potential recipients are aware that they will not definitely be getting the kidney until the result of the cross-match is known. Inform patient re: ureteric stent insertion with cystoscopic removal required at 3 months, (usually as a day case). CAPD catheter also removed at the same time as ureteric stent.

Consent for HIV test - Verbal consent should be obtained by the physician who clerks the recipient.

Consent for the transplant operation should be obtained by the transplant surgeon. (mention central line, surgical drain, urinary catheter and ureteric stent).

If transplant does not go ahead - patients who are not suitable for transplant need discharge sheet with appropriate reasons. (Appendix V)

Staff

Inform theatre and anaesthetist of any special problems.

Post-op, ensure that information is passed on and recorded about the operation and immediate urine output.

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History Exam Investigs << >> Fluid and potassium

This page last modified 25.01.2011 10:11 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Live kidney donors will be seen at the Transplant Assessment Clinic two weeks prior to the scheduled transplant date. Blood samples will be taken at this visit for: repeat virology lymphocytotoxic crossmatch advance group and save

Admission is arranged 24 hours pre-op to the Transplant Unit. In exceptional circumstances if there are no beds available on Ward 206 Transplant then a bed will be found for the donor according to the charge nurse of ward 206 in liaison with the hospital bed-manager.

On admission the donor should have receive a full physical examination; blood pressure; temperature; urinalysis and urine specimen sent to bacteriology.

No pre-op X-Ray/ECG/ blood tests are necessary unless requested by a Consultant.

Written consent for a nephrectomy should be obtained by the Consultant Transplant surgeon.

All donors should receive DVT prophylaxis with TED stockings, intra-operative pneumatic compression and heparin. Post-operative: heparin sub-cut 5000u BD.

Pre-op heparin should not be administered unless the Consultant Anaesthetist specifically requests.

Post-op fluid management: 4 - 6 hourly dextrose/saline

Any problems should be reported directly to the Consultant Surgeon.

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Pre-Op Recipient << >> Post op Management

This page last modified 08.09.2009 13:15 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Fasting

All patients should be fasted from four hours prior to the anticipated theatre time unless otherwise stated by surgeons or anaesthetists.

Fluid balance

A critical appraisal of the patient's fluid status must be performed, and should include - supine and erect blood pressure recordings, detailed assessment of JVP and peripheries. Patients may well be relatively fluid deplete, especially those undergoing haemodialysis. Once the final results are known and it is accepted that the patient is going ahead to transplant, then any obvious fluid depletion should be corrected, by intravenous therapy. The insertion of a central line in the pre-operative phase is not indicated, except in unusual circumstances. (A central venous line is inserted immediately after induction of anaesthesia to allow central venous pressure monitoring and guide fluid replacement, both per-operatively and post-operatively).

Potassium and pre-op dialysis

(i) Patients on peritoneal dialysis

Continue peritoneal dialysis until immediately pre-op (abdomen should be emptied 30 - 45 minutes pre-operatively.

(ii) Patients on haemodialysis

Patient may require haemodialysis because: a. dialysis is due irrespective of transplant b. based on the results of admission U’s & E’s.

In practice, unscheduled haemodialysis is unlikely to be required except for hyperkalaemia.

(iii) Pre-operative Management of serum potassium

The objective is to ensure that the serum [K+] is between 5 and 5.5 mmol/l when the patient goes to theatre. It is the responsibility of the renal FY2/ST or HAN team to obtain the potassium result and act upon it.

If serum [K+] ≥ 4 and surgery is likely to be more than six hours later: Standard maintenance:

500ml of 10% dextrose at 40 ml/hr (non-diabetic patients) 500ml of 10% dextrose with 16 units Actrapid at 40 ml/hr(for diabetic patients) nebulised salbutamol 5 mg six hourly

If serum [K+] is 5 - 5.5 treatment is required.

Initial treatment; maintenance regime plus insulin/dextrose given as 5 units Actrapid and 50 ml 50% dextrose over 15 minutes. Potassium and BM should be checked after 60 minutes. Patients who fail to respond may require dialysis.

If serum [K+] >5.5 the patient will usually require haemodialysis. The registrar or consultant should be informed.

Immediate measures are continuous ECG monitoring and 10 ml calcium gluconate slow IV, if ECG changes present, and repeated once if required.

Notes

1. Post-dialysis potassium must be checked from a venous sample taken at least 5 minutes after the end of dialysis. 2. The maintenance regime is only designed to prevent a rise in serum [K+] and is not appropriate when the serum [K+] requires reduction. 3. There is no place for calcium resonium or sodium bicarbonate in the control of pre-transplant potassium.

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History | Examination | Investigations

Particular points of note:

History

cause of renal failure dialysis - type, when commenced time of last dialysis –normal target or dry weight access and any related problems volume of urine output + history of past/present, urinary tract problems infections - any recent urinary CAPD peritonitis/exit site/access related other operations ischaemic heart disease peripheral vascular disease

Recipient blood group, tissue typing and virology (CMV, EBV,HIV, HBV and HCV) must be recorded in the notes. Donor details should also be included in recipient clerking - age, cause of death, blood group, tissue typing, virology and cross clamp time if known. The transplant co-ordinator will provide this information. NOTE: Donor confidentiality must be maintained at all times.

Examination

A full physical examination of the patient should be performed and should include observation of:

1. fluid status 2. peripheral pulses 3. abdominal scars/hernias

Investigations

Blood - phone laboratory to alert staff that sample is arriving. Samples must be hand delivered. Dialysis may be required prior to operation depending on this result (if so, repeat U& Es are required 30 minutes following dialysis). 60-70 mls blood required for initial set and should be taken as soon as patient is admitted.

*FBC -*U&E's + creatinine and glucose Baseline calcium/LFT's *Clotting screen/INR (if on Warfarin) *Blood Group and save *Tissue Typing (white clotted bottle for lymphocytotoxic Antibody, plus 5 ml EDTA sample.) see appendix IV*Clotting screen/INR (if on Warfarin) Virology - CMV, HIV, HBV and HCV (only if >1/12 since last test, this will be tested the next working day) BM test on ward

*Results must be requested as Urgent and be available before theatre.

Chest X-ray

ECG

MSSU - for gram stain and subsequent culture

PD fluid for WCC and gram stain / culture if appropriate

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| Immunosuppression | DVT | Ulcer | Bone

Prior medication

Anti-hypertensives are taken as usual pre-operatively except ACE inhibitors and angiotensin II antagonists are omitted. Other anti-hypertensives may also be selectively omitted post-operatively and re-introduced if required

Also omit

NSAIDS Diuretics Warfarin (reverse if necessary) Aspirin - should be reviewed Phosphate binders (usually) - see Bone and calcium below

Rhesus +/-

Rh -ve young female recipients with a Rh +ve donor require anti D immunoglobulin at induction. This can be given up to 72 hours later if overlooked initially.

Diabetes - glycaemic control

Subcutaneous insulin should be omitted. Insulin/Dextrose infusion must be established pre-operatively:-

BM < 6 mmol/l add 6 units Actrapid in 500mls Glucose 10% BM 6 - 9 mmol/l add 10 units Actrapid in 500mls Glucose 10% BM >9 mmol/l add 14 units Actrapid in 500mls Glucose 10% Run Infusion at 100 ml/hr. BM should be checked every hour

(see sample drug kardex – appendix VII)

Antibiotic prophylaxis

Given at induction of anaesthesia - Piperacillin/Tazobactam 4.5g IV. If patient is a carrier of MRSA add Vancomycin 1g IV in Normal Saline over 2 hours. If allergic to penicillin, omit Pip/Tazo and give Vancomycin as above plus Ciprofloxacin 400 mgs infused over 60 min. (confirmed May 2012 due for review May 2014)

Valganciclovir

All transplant recipients except CMV –ve recipients of CMV –ve donors should receive valganciclovir, which has replaced Ganciclovir for prevention of CMV disease. Prescriptions should be initiated in hospital within 10 days of transplantation. Therapy will be continued in primary care for up to a total of 180 days treatment for which a shared-care protocol will be provided (see appendix VIII). See full CMV protocol

The initial Valganciclovir dose is dependent on creatinine clearance (Cockcroft and Gault equation) as shown in the table below:

Creatinine clearance Prophylactic dose (ml/min) >60 900mg od 40 to 59 450mg od 25 to 39 450mg every 2 days 10 to 24 450mg twice weekly 100mg three times a week after <10 dialysis

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Valganciclovir is available as 450mg tablets (pink) or oral solution for dialysis patients and the brand name is Valcyte. The tablets should be taken with food and not broken or crushed.

Pneumocystis prophylaxis

Co-trimoxazole 480mg per day for 3 months. Full pneumocystis protocol

Immunosuppression

See separate Immunosuppression protocol

DVT prophylaxis

Heparin 5000U/SC at anaesthetic induction and 5000U/SC/bd thereafter until mobile post operatively.

Peptic ulcer prophylaxis

Ranitidine 150mg bd preferred; alternative omeprazole 20mg daily.

Bone and calcium

Calcichew 2 tabs at night and alfacalcidol 0.25micrograms od unless corrected calcium is >2.5mmol/l. If requiring more alfacalcidol/calcitriol pre-op, usually continue higher dose. If on cinacalcet or other therapy for calcium, discuss but usually continue in early post-op period. Bisphosphonates may be considered for second or subsequent grafts or known osteoporosis (See p.22)

All these drugs including immunosuppression should be prescribed in the drug kardex pre-operatively.

Further info

NHS Lothian shared care protocols Lothian joint formulary (click on Adult or Children etc. Other useful links on this page)

Date last modified is shown in the footer. Major revisions archived below. Antibiotic prophylaxis updated May 2012.

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Fluid and potassium << (no next)

This page last modified 05.05.2012 13:51 by ANT. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Return from theatre and Day One

Check FBC and Us & Es immediately post-op. Serum K+ must be known and result discussed with Registrar, if possible hyperkalaemia should be managed with Insulin/dextrose and nebulised Salbutamol rather than haemodialysis. Subsequent repeat Us & Es 12 hourly (more frequently if indicated or as decided by Registrar).

Arrange chest X-ray for position of central line, if not already performed in recovery.

Initial IV fluid replacement is Normal Saline at 40 mls/hr + last hour's urine output. This should be adjusted according to clinical assessment and CVP. Usual target CVP is 5-10 cm H20. Boluses of Normal Saline (or colloid) may be needed to raise a low CVP. Failure of the patient to respond to IV fluid with a rise in CVP or BP should raise possibility of bleeding. These measures should always be instigated by a senior member of staff. If there is a possibility of bleeding a transplant surgeon must be contacted. Continuing IV fluid replacement should initially be maintained with alternating 5% Dextrose and Normal Saline.

Analgesia is by PCA fentanyl. Inadequate pain relief may herald serious pathology and should be discussed with a senior surgeon/Anaesthetist. NSAIDs are absolutely contraindicated. Live donors will receive an epidural infusion (see appendix VI).

Post-op anuria - check catheter function. Check with surgeon or operation note whether expected. Gentle catheter irrigation should only be performed after surgical consultation and preferably by the surgeon. If it continues, see Delayed Graft Function

Prescribing - see immunosuppression protocol and pre-op prescribing

First few days

Blood Tests

U&E daily FBC daily LFTs, glucose, calcium, phosphate – daily Tacrolimus or Ciclosporin level - M/W/F

Chart all blood results on flow charts (creatinine on log creatinine graph)

MSU each Monday and at other times if clinically indicated.

Redivac drain removed at 24-48 hours at surgeon’s discretion.

Urinary catheter removed at day 5 unless: -

the patient is anuric (removed earlier) or the patient is polyuric (removed later) advised differently by transplant surgeon

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Delayed graft function

In all cases of DGF an ultrasound and Doppler of the graft should be performed on day 1.

Due to prolonged ischaemic times/ATN etc., not all kidneys function immediately and some take a few days or even weeks before functioning. During this time the aim is to ensure that we are not missing concomitant rejection or other catastrophe.

1. Day 1 Duplex scan Routine immunosuppression

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2. Day 5-7 If no evidence of improvement then biopsy to exclude rejection. 3. Around day 12 Repeat Duplex/biopsy.

Treat biopsy-proven rejection with iv pulsed methylprednisolone 3x500mg. Occasionally, 3 x 250mg given without biopsy on day 5, if particular reasons to avoid biopsy, e.g. risk of bleeding.

Graft dysfunction

Any drop in urine output or rise in creatinine should be discussed immediately with a senior colleague. Management will depend on the clinical situation. Fluid balance assessment is essential but acute rejection must always be suspected. Physical signs are often absent and urgent investigation is required. Think about ...

Fluid balance - clinical assessment, weight, fluid charts Check tacrolimus (prograf) / ciclosporin result Graft tenderness, fever, or other signs of infection - MSU result; virus infections especially CMV Graft ultrasound scan - will exclude obstruction. Graft Doppler - assesses flow in renal artery and vein (may also comment on intra-renal vascular resistance). Graft biopsy - for definite diagnosis of rejection.

An increase in creatinine may be caused by a number of processes, but common causes are:

Rejection Infection, e.g. urine, CMV Tacrolimus / Ciclosporin toxicity Altered fluid balance

Less common causes are:

Vascular catastrophe Mechanical problem - urinary obstruction (less likely if ureteric stent present) Lymphocele

Renal Biopsy

Full allograft biopsy protocol. A routine graft biopsy is performed around day 5 if there is delayed graft function and subsequently at weekly intervals until function is established. This is to diagnose acute rejection co-existing with ATN.

Any deterioration in graft function may require a graft biopsy which will be requested by a senior member of staff. Refer to biopsy protocol.

Heparin should be stopped the evening prior to the planned biopsy.

Antibody samples should be sent to Tissue Typing on all patients receiving a biopsy.

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Pre-op live donor << >> Discharge

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Uncomplicated patients are discharged day 10-14.

Prograf / Ciclosporin / MMF shared care protocol must be included with the immediate discharge letter (www.ljf.scot.nhs.uk). Formal discharge summary is dictated on the day of discharge. Copies should be faxed to parent units as soon as they are available and telephone contact made with the receiving physician to arrange quick follow-up.

Transfer to Referring Renal Unit

When patients are transferred to their local referring renal unit prior to discharge home the centre must be contacted before and on day of discharge. A copy of the patient transfer details sheet (medical and nursing) (Appendix V) with a computer printout of the biochemistry, haematology, Tacrolimus results and discharge letter should accompany patient on transfer and/or faxed to receiving unit.

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Post op Management << >> Follow up

This page last modified 03.12.2009 10:29 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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After a new transplant, recently discharged patients usually attend 3 times weekly. Aberdeen, Dundee and Inverness patients: Usually transferred when stable as in-patients to the Renal Unit at the referring Hospital. Fife patients: Discharged home from RIE when stable. Contact Fife consultant prior to discharge to update and make arrangements for outpatient review in Fife.

In Edinburgh Transplant clinics are on Monday, Wednesday and Friday mornings in OPD1. If there is no clinic or if a patient needs to be seen more frequently then they will be seen on the Transplant ward following discussion with the nurse in charge. Appointments should be recorded in the Diary including what tests are required, any special arrangements and the date of the next appointment. Patients should always attend before 9.15 am so that their drug assays may be run the same day. Complete blood forms in advance so that the phlebotomist can take their blood during the ward round. The responsibility for checking the results on such patients lies with the ward SHO and registrar covering the unit.

Regular outpatient reviews

At each out-patient review the following are checked:

Blood pressure ( pulse, temperature only if necessary) Weight Blood U&E, LFT, CAP, FBC and Tacrolimus/Ciclosporin. Blood should not be taken from or IV cannulas inserted into limbs with established AV fistulas. MSU Urine dipstick Medication - any alteration to immunosuppression required should be documented on the patient’s medication sheet which was issued to the patient on discharge, and updated on the Proton computerised record by the clinician making the alteration. Prograf / Advagraf should be recorded on patient’s computerised records. PTH checked 1 month, 3 months and 6 months Post-transplant antibody samples at 1, 2, 3, 6, 12 months and all subsequent anniversaries or rejection episodes.

Results of out-patient bloods must be checked as soon as possible and patients may be recalled for repeat checks or phoned to alter their dose of Prograf/Advagraf or ciclosporin. Any alteration to dose should be documented in the patient’s case notes and on the drug screen of Proton.

Three months

Ureteric stent and CAPD catheter if present normally removed at 3 months post transplant.

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Discharge << >> Immunosuppression

This page last modified 25.01.2011 12:20 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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IMMUNOSUPPRESSION PROTOCOL - OCTOBER 2009

EDINBURGH, INVERNESS, ABERDEEN, DUNDEE, FIFE.

Introduction

The regimens outlined below have been developed with the collaborative efforts of all Renal Units in the East of Scotland. The main aims of these protocols are to reduce the incidence of early acute rejection and to optimise allograft function.

As patients return to their local Renal Units post-transplantation, it will be the responsibility of the local nephrology teams to tailor immunosuppression in the long-term. The options for maintenance therapy will be outlined below.

Cadaveric Heart-beating Renal Transplant

(1) Standard Regimen

This regimen applies to all first, unsensitised cadaveric graft recipients with no DR-mismatch.

(2) Intermediate risk patients

This group includes simultaneous kidney/pancreas transplants, previous transplant, sensitised patients, FACS positive crossmatch, any DR-mismatch, non-favourable match, black race. The only difference here is the target trough level of tacrolimus is higher.

Pre-op MMF 1g (at admission) Tacrolimus 0.05mg/kg

Peri-op Simulect 20mg Methylprednisolone 500mg in theatre; 500mg at 24hrs post-op

Prednisolone 20mg daily (reducing to 5mg at 3 months) MMF 1g bd at 08:00 and 20:00 hrs Post-op Tacrolimus 0.05mg/kg bd at 10:00 and 22:00 hr

1. Standard regimen target trough level 5-10

2. Intermediate risk patients target trough level 10-14 in first 3 months target trough level 5-10 after 3 months

Day 4 Simulect 20mg

Live Donor Renal Transplant

All live donor transplants, including those from unrelated donor, will receive the standard regimen as above BUT with pre-treatment starting 2 days pre-transplant. The tacrolimus dosage for pre-treatment will be half of the standard dose post-transplant.

Pre-op Prednisolone 20mg (start 2 days pre-Tx) MMF 1g bd at 08:00 and 20:00 hrs Tacrolimus 0.025mg/kg bd at 10:00 and 22:00 hrs

Then as for cadaveric heart-beating donor (as above)

Non-Heart Beating Cadaveric Renal Transplant

The differences here are that patients do not get tacrolimus pre-operatively, and the target trough level is lower than for heart-beating

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donors.

Pre-op MMF 1g

(At admisson)

Note: No pre-op tacrolimus given

Peri-op Simulect 20mg Methylpredinsolone 500mg in theatre; 500mg at 24hrs post-op

Prednisolone 20mg daily (reducing to 5mg at 3 MMF months) Post-op Tacrolimus 1g bd at 08:00 and 20:00 hrs 0.05mg/kg bd at 10:00 and 22:00 hrs

target trough level 5 - 7

Day 4 Simulect 20mg

Note: if a patient has a kidney transplant from a non-heart beating donor, and is considered to be at increased risk of rejection, the consultant clinicians responsible for the patient should alter the target trough level of tacrolimus at their discretion, and depending on the clinical scenario.

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Recommended Steroid Tapering

Week 1 Prednisolone 20mg Week 4 Prednisolone 15mg Week 8 Prednisolone 10mg Week 12 Prednisolone 5mg

Mycophenolate Mofetil

Maintaining the dosage of MMF is essential to allow minimisation of CNI dosage. However, side-effects may occur.

Gastrointestinal side-effects are common. Consider:

An alternative cause of diarrhoea and exclude infection A small dose reduction and/or splitting dose to tds or qds Switching to Myfortic 720mg bd

Leucopenia may occur. Exclude CMV infection. Consider:

A small dose reduction and monitor white cell count.

CMV Prophylaxis

All patients receiving a kidney and/or pancreas transplant except CMV negative recipients of CMV negative grafts should receive prophylaxis with Valganciclovir (dosing according to eGFR)

Duration of prophylaxis should extend to 6 months (180 days)

Treatment of Acute Rejection

Acute rejection should be confirmed with percutaneous transplant biopsy. Treatment: Methylprednisolone 500mg IV daily for 3 consecutive days. Review maintenance regimen– tacrolimus trough level should be increased to 7-10. Steroid-resistant acute rejection – Anti-thymocyte globulin (ATG) should be considered.

Long-term Immunosuppression

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The immunosuppressive regimen will be reviewed at 6 months post-transplant by the nephrologist responsible for the care of the patient. Patients will be informed prior to transplantation that their immunosuppressive regimen will be reassessed at this stage and may involve a change of medication, change in dosage of medication or continuation of the initiating regimen. This decision must be clearly documented.

It will be the choice of individual Renal Units to decide if they wish to pursue steroid withdrawal or CNI dose minimisation. This decision may be taken on an individual patient basis.

Proposed options for long-term Immunosuppression:

Low risk recipient consider:

Steroid withdrawal Replacing MMF with Azathioprine

Creeping creatinine consider:

Lower CNI level

NODAT consider:

Steroid withdrawal Low CNI level

Pregnancy (this is mandatory):

Replace MMF with Azathioprine prior to conception or as soon as possible after conception in the event that pregnancy was unplanned.

Data Collection

As transplant follow-up will be devolved to regional centres, it is essential to collection transplant follow-up data for accurate assessment of this revised immunosuppression protocol. Each unit should nominate a lead clinician to coordinate data collection and liaise with their respective transplant coordinator.

Each Unit should collect data on:

Number of patients transplanted each year Acute rejection episodes – timing post-transplant, severity (Banff grade), treatment (including use of antibody) Immunosuppressive regimen at 6 and 12 months Serum creatinine at 6 and 12 months eGFR (MDRD) at 6 and 12 months Infections during first 12 months (CMV, BK virus, other) Malignancy during first 12 months (non-skin) New-onset diabetes after transplantation (NODAT) Graft survival at 12 months Patient survival at 12 months

It is planned that Scottish Renal Registry data collection should be used to facilitate this and that data fields should be set up to enable this to happen.

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Follow up << >> Immunosuppressive drugs

This page last modified 25.01.2011 12:35 by ANT. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Current indication

Third agent in standard triple therapy.

Dose

Initial 1-2 mg/kg once daily.

Maintenance 1 mg/kg once daily.

Monitoring No monitoring of drug levels is required.

Preparation

Azathioprine is available as 25 mg and 50 mg tablets. There are both generic and brand (Imuran) forms on the market.

Administration

Virtually exclusively oral, although an IV preparation is available.

Contra-indications

Pregnancy

Bone marrow dysfunction, i.e. Patients who are known to be leucopaenic or thrombocytopaenic.

Reduce dose if hepatic dysfunction is present.

Drug Interactions

Allopurinol must not be co-prescribed as an inhibition of xanthine oxidase results in potentially fatal accumulation of azathioprine and its metabolites. An alternative uricosuric- benzbromarone is available on a named patient basis. Contact transplant unit pharmacist for further details.

Side Effects

Bone marrow suppression - usually reversible following cessation.

Cholestatis and disturbed liver function - again usually reversible.

Pancreatitis

Dose may require to be altered depending on WCC, i.e., reduce if WCC<4.0, stop if WCC <3.0 and re-introduce at a lower doses when WCC>3.0.

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Mycophenolate Mofetil (MMF) << >> Sirolimus (Rapamune)

This page last modified 05.11.2009 12:37 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Merieux Anti-Thymocyte globulin (ATG)

With the introduction of Tacrolimus and MMF, rejection resistant to steroids or these agents is uncommon.

Indication

May be given for treatment of rejection episodes in steroid resistant rejection (persistent biopsy proven rejection despite two courses of methylprednisolone).

Contra-indications

known allergy to rabbit proteins acute viral illness full anaphylactic response to the test done.

Dosage and administration

ATG is usually given over a 10 day period with an absolute T-cell count determining the administration schedule (ATG only given if absolute T-Cell count >0.05).

Test dose

A test dose is needed to identify those patients who will develop severe reactions including anaphylaxis. Signs of anaphylaxis are tingling in the extremities and around the mouth, swelling of the lips and larynx, bronchospasm, tenesmus, hypotension. Any reaction will normally respond to hydrocortisone 100 mg IV and chlorphenaramine 10 mg IV although 0.5 ml adrenaline 1:1000 IM may be necessary.

Administration of test dose

5 mg ATG in 100 ml NaCl 0.9% can be infused through a peripheral vein over 1 hour, although administration via a central vein is preferable. Pre-dose administration of 1g paracetamol and 10mg chlorpheniramine iv is recommended.

Preparation of test dose

One vial contains 25 mg ATG. Reconstitute vial contents with accompanying diluent (5 ml water for injections), giving a solution of 5 mg ATG per ml. Take 1 ml of solution and add to 100 ml NaCl 0.9%.

Observations during / after test dose

Observe patient closely Monitor BP, pulse and temperature according to the following schedule:

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Time after dose Frequency of observations 0 - 2 hrs 15 mins 2 - 4 hrs 30 mins thereafter hourly

• First full dose

Administration

ATG 1.5mg/kg in 0.9% NaCl given over 6 - 8 hours via a central line. Round the dose to the nearest 25 mg.

Preparation

Reconstitute required number of vials with 5 ml diluent per vial. Add contents of reconstituted vials to 0.9% NaCl, allowing 50 ml per vial (250 ml bag usually appropriate).

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Observations

Observations as for test dose.

• Further doses Further doses given when absolute T cell count >0.05. if <0.05, ATG not given. It is unlikely that ATG will need to be given daily: more usually only 3 doses are needed over the 10 day period.

To allow calculation of T cell count, need: DAILY FACS - convert result to decimal to plug into equation, e.g. 30% = 0.3 DAILY LYMPHOCYTE COUNT

T cell count is determined as follows:

No. lymphocytes x FACS result = T cell count e.g. 0.2 x 0.3 = 0.06.

Side effects

Anaphylaxis, with a drop in arterial pressure, respiratory distress, fever and urticaria may appear during or just after the infusion.

Other hypersensitivity reactions include rigors (1%), fever (4%), arthralgia (1%), erythema (1%) and pruritic skin eruptions (0.5%). Symptoms are most commonly seen after the first injection and decrease during the course of treatment.

Other side effects include thrombocytopenia (approx. 5%), neutropenia, serum sickness (3%) and lymphoma.

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Monitoring

See observations.

Also:

Daily differential WCC for lymphocytes } for T cell count determination FACS } for 10 day course

Daily: FBC } during 10 day course and for 2 weeks after U & E's

Interrupt treatment if platelet count <50000 / mm3

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Consider interrupting treatment if <2000 leukocytes / mm3

Interactions

Risk of over-immunosuppression, hence the following schedule should be followed:

DRUG DAY

0 1 2 3 4 5 6 7 8 9 10 11-30 31+ ATG Full ********** Tacrolimus/ YNNNNNNY2 Y2 Y2 Y2 Y2 Y2 Ciclosporin Prednisolone YYYYYYYYYYYYY Azathioprine/ YNNNNNNNYYYYY Mycophenolate mofetil

PCP prophylaxis1 YYYYYYYYYYYYY

*Depending on T cell count

1. For PCP prophylaxis use cotrimoxazole 480 mg daily, if patient allergic to co-trimoxale then the cotrimoxazole de-sensitisation protocol should be used (see page 39.) Continue if need to complete 3 month course.

CMV and HSV prophylaxis using Valganciclovir for 6 months should also be used (see page33).

2. Tacrolimus reinstated at dose of 0.05 mg / kg twice daily. Ciclosporin reinstated at dose 3 mg / kg twice daily.

Ordering

Mon-Fri 8.30 - 1700: contact unit pharmacist.

Out of hours: contact resident pharmacist, bleep 2268 small stock held in pharmacy.

Storage

Both the dry powder and reconstituted solution to be stored in fridge; protect from light.

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Sirolimus (Rapamune) << (no next)

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You are here: Handbooks » Transplant Handbook » Immunosuppressive drugs » Basiliximab

Protocol for Basiliximab (Simulect)

Indication

All patients receiving kidney and/or pancreas transplants

Dose

20mg given at induction of anaesthetic 20mg given on day 4 post transplant

Reconstitution

1. 5ml water for injection (provided) should be added to the vial containing the Basiliximab powder. 2. Shake the vial gently to dissolve the powder 3. The solution should be used immediately (it can be stored for 24hours in the fridge or 4 hours at room temperature.)

Administration

There are two possible routes of administration

1. Intravenous bolus injection 2. Intravenous infusion over 20-30 minutes (final volume of at least 50ml using sodium chloride 0.9% or dextrose 5%.)

Compatibility

Basiliximab should not be mixed with other medicines/substances and should always be given through a separate infusion line.

Adverse Effects

Severe acute hypersensitivity reactions have been observed - including anaphylactoid-type reactions - both on initial exposure and re-exposure to basiliximab. If severe hypersensitivity reaction occurs, therapy with basiliximab must be permanently discontinued and no further dose administered.

Side Effects

Basiliximab does not appear to add to the background of side effects seen in organ transplantation patients as a consequence of their underlying disease and concurrent administration of immunosuppressants.

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(no previous) >> Prednisolone

This page last modified 27.01.2011 11:35 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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You are here: Handbooks » Transplant Handbook » Immunosuppressive drugs » Cyclosporin

Current Indication

No longer a first line agent but some transplant patients will still have Neoral (previous formulation Sandimmun but nearly all patients are on Neoral) as the lead agent in their immunosuppression regime.

Dose

Starting dose is 8 mg/kg/day in 2 divided doses.

Preparation

Ciclosporin is available 10 mg (yellow / white), 25 mg (blue / grey), 50 mg (yellow / white) and 100 mg (blue / grey) capsules and as a 100 mg/ml oral solution. The brand name is Neoral.

Administration

Oral route in most instances. It is administered usually at 10 am and 10 pm. Oral solution should be diluted immediately before taking. May be diluted in orange juice or squash, apple juice or water (not grapefruit juice - see interactions). Needs to be stirred well. Measuring device should not come into contact within the diluent.

One third of the oral dose can be given as a slow intravenous infusion in normal saline or dextrose 5% over 2-6 hours if absolutely necessary.

Contra-indications/Cautions

Live vaccines are not to be given to immunocompromised patients. Neoral should be used with caution during pregnancy. Ciclosporin passes into breast milk so mothers should not breast feed their infants.

Side effects

The most frequent side effects seen with Ciclosporin include:

abnormal kidney function hepatic dysfunction hypertrichosis gingival hypertrophy tremor gastointestinal disturbances hypertension burning sensations of hands and feet

Less common side effects are:

headaches rashes (possible allergic origin) weight increase oedema mild anaemia pancreatitis hyperkalaemia neuropathy hyperuricaemia reversible dysmenhorrhoea hypomagnasaemia muscle weakness, cramps or myopathy hypercholesterolaemia Up to top

Interactions

Potential interactions due to effects on hepatic microsomal enzymes

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Inhibitors of cytochrome P450 which may decrease metabolism of ciclosporin and thus increase ciclosporin blood levels include:

clarithromycin erythromycin nicardipine danazol fluconazole oral contraception diltiazem ketoconazole verapamil

Inducers of cyctochrome P450 which may increase metabolism of ciclosporin and thus decrease blood levels include:

barbiturates phenytoin carbamazaepine rifampicin

Interactions due to cumulative toxicity / synergistic effects

Take care when using ciclosporin in combination with compounds known to have nephrotoxic effects, e.g.: aminoglycosides, ciprofloxacin, trimethoprim, amphotericin B, melphalan and NSAIDs.

Concurrent administration of ciclosporin with HMG-CoA reductase inhibitors may enhance risk of rhabdomylosis. Concomitant administration of nifedipine and ciclosporin increases the rate of gingival hyperplasia when compared to that for ciclosporin alone, particularly in the presence of poor oral hygiene. Since ciclosporin may cause hyperkalemia, potassium sparing diuretics, potassium supplements and high potassium intake should be avoided.

Other interactions

Vaccines may be less effective and the use of live attenuated vaccines should be avoided.

Owing to its possible interference with the gastrointestinal cytochrome P450 enzyme system, grapefruit or grapefruit juice should not be taken 1 hour prior to ciclosporin dosing and grapefruit juice should not be used as a diluent for the oral solution.

This is not a comprehensive list of all potential interactions with ciclosporin. For further information please ask senior members of staff or consult the transplant unit pharmacist.

Levels: (currently under review) Target levels: 0-3 months: 80-120 After 3 months: 80-100

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Tacrolimus << >> Mycophenolate Mofetil (MMF)

This page last modified 05.11.2009 12:12 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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You are here: Handbooks » Transplant Handbook » Immunosuppressive drugs » Prednisolone

Prednisolone is normally reduced according to the following schedule:

20 mg x 1 month started on day 2

15 mg x 1 month

10 mg x 1 month

5 mg x thereafter

At 3 mths to remain on minimum of 5 mg or 7.5 mg if >75 kg in weight. To remain on maintenance dose until the end of the first year and then reviewed.

At one year, cessation of Prednisolone should be considered (See steroid withdrawal protocol).See page 38. NB caution should be exercised in patients with an “increased risk” of rejection, See page 16.

All patients to receive Ranitidine (150 mgs od) along with Prednisolone. This schedule may be altered if rejection occurs.

* Cautions relating to Steroid withdrawal include: -

FACs +ve

> 2 transplants

Panel reactive antibodies > 50%

Patients with intermediate risk as defined on p. 16

Rejection episodes:1 or more acute rejection episodes Banff grade > II

Proteinuria

Late acute rejection ie occurring after 6 months

Steriod withdrawal

Steroid withdrawal should be discussed with the patient and they should be informed of the increased risk of rejection. The steroids should be withdrawn according to the following schedule:

Decrease by 1 mg per month to 0mg The patient requires at least monthly blood for creatinine

Steriod induced osteoporosis

All patients should receive additional elemental calcium, this may be as one or two tablets per day depending on dietary intake.

If GFR > 50 mls/min Calcichew D3 should be used. If GFR < 50 mls/min Alfacalcidol and Calcichew should be used.

Bisphosphonates

IV Pamidronate may be used in the initial post transplant period in patients with - known osteopenia or osteoporosis, a history of one or more previous transplants, 2 or more episodes of rejection (treated with high dose steroid therapy) or a history of previous disease management with steroids. All patients should be given advice on:

Diet

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Weight Exercise Smoking cessation Skin surveillance

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Basiliximab << >> Tacrolimus

This page last modified 27.01.2011 11:39 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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You are here: Handbooks » Transplant Handbook » Immunosuppressive drugs » Sirolimus (Rapamune)

(Rapamune®)

(should not be prescribed as rapamycin)

Indication

As an adjunct to or substitute to a calcineurin phosphatase inhibitor for immunosuppression in patients in whom ciclosporin/tacrolimus have been implicated in allograft pathology.

Contraindications

Hypersensivity to Sirolimus and its derivatives. Pregnancy and breast feeding.

Presentation - 1mg and 2mg tablets

Dosage and Administration Doses should be given on an empty stomach Day 1 6mg daily Day 2 6mg daily Day 3 onwards 2mg daily adjusted according to levels

Monitoring

Target range 5-15ng/ml depending on whether it is an adjunct to or substitute for a CNI. As an adjunct to CNI: CNI levels with concurrent sirolimus should be lower eg. Tacroimus levels 3-5

Switch from tacrolimus to sirolimus

If clinically indicated, patients may be switched from tacrolimus to sirolimus. This can be performed abruptly.

Tacrolimus is stopped the night before giving 8mg sirolimus on day 1, 4mg on day 2, then 2mg and levels are measured.

Side Effects

Raised triglycerides & Mouth Thrombocytopeania cholesterol Ulceration

Anaemia Neutropenia Proteinuria

Hypokalaema Arthralgia Epistaxis

Delayed wound healing Lymphocele Rash

Oedema Infections

PTLD Diarhoea

Drug Interactions

Compounds which modulate CYP3A4 activity may effect Sirolimus levels. Drugs which may increase sirolimus levels

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Diltiazem Bromocriptine

Azole antifungals Cimetidine

Macrolide antibiotics Danazol

Prokinetic agents Protease inhibitors

Grapefruit juice

Drugs which may decrease Sirolimus levels

Rifampicin

Anticonvulsants

Caution should be exercised with concomitant administration of nephrotoxic drugs.

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Azathioprine << >> ATG

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You are here: Handbooks » Transplant Handbook » Immunosuppressive drugs » Tacrolimus

(PROGRAF/ADVAGRAF)

Current indication

As the lead agent in standard triple therapy for all patients.

Dosage

0.025 - 0.1 mg/kg/day in 1 - 2 divided doses (normally between 2 mg and 5 mg od-bd).

Preparation

Tacrolimus is available as 0.5 mg (cream), 1 mg (white) and 5 mg (greyish red) capsules.

The brand name is Prograf for the twice daily preparation.

The brand name is Advagraf for the once daily preparation.

Always prescribe by brand name as serious drug errors have occured.

Prograf will be used in the initial post-operative period. Patients can be switched to Advagraf once stable levels have been achieved, usually in the outpatient clinic.

Administration

Oral route in most instances (well absorbed even in those with NG tubes).

It is administered usually at 10 am and 10 pm. The capsules are taken on an empty stomach either 1 hour before or 2 - 3 hours after meals. Contents of the capsule can be suspended in water for NG administration. One fifth of the oral dose can be given as a continuous IV infusion in saline via non PVC bags/tubing if absolutely necessary.

Levels Whole blood trough levels to be checked on Mondays, Wednesdays and Fridays.

Doses and Target levels: Standard regimen for low risk recipients: Dose: 0.05mg/kg bd Target level: 5-7 Standard regimen for intermediate risk recipients: Dose: 0.05mg/kg bd Target level: 10-14 for 3 months 5-10 after 3 months

In adult kidney transplant patients steady state may be reached 2-3 days after starting therapy or changing dose.

Contra-indications

Live vaccines are not to be given to immunosuppressed patients. (See page 44).

Tacrolimus is contra-indicated in pregnancy. As it is not known to what extent Tacrolimus may influence the efficacy of oral contraceptives it is generally recommended that other forms of contraception be used.

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Side Effects

The most frequent side effects seen with Tacrolimus include:

abnormal kidney function (similar to Ciclosporin) tremor headache paraesthesia

Less common side effects are:

diarrhoea hypertension hyperglycaemia hyperkalemia hypomagnesaemia visual and neurological disturbances (affected patients should not drive or operate machinery) hypertrophic cardiomyopathy (in paediatric patients with trough levels >25 mg/ml).

Interactions

Potential interactions due to effects on hepatic microsomal enzymes.

Tacrolimus is extensively metabolised via the hepatic microsomal cytochrome P450 3A4 isoenzyme. Concomitant use of substances known to inhibit or induce cytochrome P450 3A4 (CYP3A4) may affect the metabolism of tacrolimus. Therefore:

Inhibitors of CYP3A4 may decrease metabolism of tacrolimus and thus increase tacrolimus blood levels, e.g.

clotrimazole diltiazem* fluconazole* nicardipine ketoconazole* danazol itraconazole* grapefruit juice (naringenin) erthromycin* ethinyl oestradiol clarithromycin* omeprazole

Inducers of CYP3A4 may increase metabolism of tacrolimus and thus decrease blood levels, e.g.

rifampicin* phenobarbitol phenytoin*

*Drugs marked with an asterisk will require a dose adjustment of Tacrolimus in nearly all patients. Other listed drugs may require dose adjustment only in individual cases.

Tacrolimus itself has a powerful inhibitory effect on CYP3A4. Thus concomitant use of tacrolimus with drugs metabolised by CYP3A4 dependant pathways may affect the metabolism of such drugs. For this reason Ciclosporin A should not be co-prescribed with tacrolimus. Patients switched from Ciclosporin to Tacrolimus should receive the first tacrolimus dose at least 24 hours after the last Ciclosporin dose.

Interactions due to cumulative toxicity/synergistic effects

Concurrent use of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the degree of toxicity. Enhanced nephrotoxicity has been observed with co-administration of:

Ciclosporin A Amphotericin B Ibuprofen

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Sirolimus (Rapamune)

As tacrolimus may cause hyperkalemia, high potassium intake or potassium sparing diuretics should be avoided.

Interactions due to plasma protein binding of Tacrolimus

Tacrolimus is extensively bound (>98%) to plasma proteins so competition with other highly protein bound drugs may result in displacement of either drug. This displacement may not be reflected in the blood levels of Tacrolimus or other drugs. Therefore, dosage adjustment may not be needed unless clinical signs and symptoms suggest otherwise.

Other interactions

Vaccinations may be less effective and the use of live attenuated vaccines should be avoided. Administration of Tacrolimus with a meal of moderate fat content reduces the oral bioavailability of the drug. Complimentary medicines may cause a variety of interactions (See page 45).

This is not a comprehensive list of potential interactions with Tacrolimus. For further information please ask a member of staff or consult the transplant unit pharmacist.

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This page last modified 27.01.2011 11:41 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Download these here. All are pdf files.

Firefox bug (July 2009): if instead of seeing the file or getting the download, you see a page of rubbish - right-click then save the page - it will turn into a real pdf file again when saved.

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Self-Administration << >> Trials

This page last modified 08.09.2009 14:49 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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You are here: Handbooks » Transplant Handbook » Trials

The 3C trial (CAMPATH, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy)

This UK multi-centre prospective randomised trial in kidney transplantation is academically led and co-ordinated by Dr Richard Haynes at the Oxford Transplant Centre. This is currently recruiting in Royal Infirmary of Edinburgh and Principle Investigator is the transplant surgeon Mr Murat Akyol. This trial is comparing different anti-rejection medication regimes after transplant. Patients over 18 who are recipients of a kidney transplant from a living or deceased donor are eligible. The following patients are ineligible; those who are receiving multiple organs, previous treatment with Campath-1H, patients with active infection or a history of cancer and patients who have lost a transplant within the previous 6 months not due to technical reasons. Trial participants will be followed-up for 5 years. On discharge from the Royal Infirmary in Edinburgh patients from the referring centres in the East of Scotland will be followed up in their local units with input from the research nurse in Edinburgh.

The induction therapy and early immunosuppression is determined by initial randomisation to be "Campath + Tacrolimus + Myfortic + NO STEROID" versus "Basiliximab + Tacro + MMMF/Myfortic + steroid". The trial involves a potential change of medication after 6 months due to the unique double randomisation design. The second randomisation at 6 months will assign participants to either "maintaining Tacrolimus" versus "switching to Sirolimus".

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Appendices << (no next)

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SELF-ADMINISTRATION OF MEDICINES PROGRAMME WITHIN THE TRANSPLANT UNIT, ROYAL INFIRMARY OF EDINBURGH

Rationale

Within the Transplant Unit part of the nursing philosophy is the promotion of independence by allowing patients to participate in the planning of their own care and thereby make informed choices. Many of the patients have suffered chronic liver or renal disease for a number of years, and have adopted the sick role. Following transplantation patients will have to take anti-rejection drugs for life and it is imperative that they have a full understanding of their drug therapy. The procedure whereby nurses administering drugs to patients whilst they are in hospital promotes dependence on nursing staff and encourages patients to remain in the sick role. It was not felt that these patients were appropriately prepared for discharge into the community. In conjunction with the Clinical Pharmacist, it was decided to investigate the possibility of a self-administration of medication programme (self-medication) within the Transplant Unit was established in 1994.

The self-medication programme is restricted to post transplant patients including readmissions.

Procedure

These guidelines detail each step of the programme, flow charts are available for a quick reminder.

A) The concept of self-medication is briefly raised with the patients during the assessment for transplantation.

B) Post-transplant the patient is given the self-medication information leaflet when they move to the ward area, or are felt to be ready to commence the programme. The programme is explained fully to the patient and the following points are stressed:

the programme is optional , nurse administration will continue if they decline to participate, although the patients are strongly recommended to participate. the key and medication will be the patient’s responsibility. Patient’s who have taken a previous overdose cannot proceed past stage three.

C) The patient is given the relevant drug information leaflets to support the information discussed by the nurses and pharmacist.

D) Having given the patient time to look at the information leaflets the patient’s informed consent should then be obtained. The self-medication consent form is signed by the patient and witnessed by the nurse/ pharmacist.

E) The assessment form is completed taking note of the exclusion criteria -

Encephalopathy Confusion Continuous IV controlled drug therapy

Patients commence at stage III. Patient’s being readmitted may commence on stage II depending on their level of knowledge. No patient can commence the programme at stage I.

F) The documentation is filed in the yellow self-medication folder and stored at the foot of the patient’s bed.

G) The pharmacist is contacted to facilitate the ordering of medication from pharmacy.

H) The patient’s individualised medication guide will be prepared by the pharmacist. This details the medication action, strengths available, dose, frequency and any special instructions. Blank spaces will be left to allow new medication to be added. When full the pharmacist will produce a new printed chart. (This will happen routinely, they should not be bleeped to do this.)

I) The medication is counted into the patient’s personal locker by the nurse and witnessed by the patient, the number of tablets noted on the compliance chart in red.

Pre-printed compliance charts, with the protocol medication, and blank spaces for other drugs are available. Blank charts are also available.

J) The patient is shown how to use the kardex.

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Points to note:

The patient signs the kardex in red to indicate they are self-medicating. Nursing staff continue to sign in black. The kardex must be easy to read, therefore the doctors must print the drug name. The date of commencing each stage should be noted on the compliance chart.

K) Stages

Stage III Commencing at 0800, the patient receives all the documentation and their own supply of medication. When the medication is due the patient asks the nurse for the key. The nurse observes the patient’s selection and administration technique providing as much support and guidance as the patient requires. The patient continues on stage III for a minimum of 48 hours or until they can safely administer their medication and record it accurately.

Patients who have taken previous drug overdoses must remain on stage III throughout their admission.

Stage II Commencing at 0800, the patient is given the key to their medication locker and reminded to keep it safe at all times.

The patient self-medicates. A compliance check is carried out at 1400.

The number of tablets remaining should be recorded for each drug. Any discrepancies should be noted in the comments box.

The patient must remain on stage II for a minimum of 72 hours.

Note: Any errors at this check should be discussed with the patient but they need not go back to stage III.

Stage I The patient self-medicates. Compliance checks are carried out weekly. No patient may commence the programme at stage I

L) It is important to stress to the medical staff the need to print the prescription clearly. The pharmacist’s routinely check the prescriptions on a daily basis. However, the charts should be checked by the nursing staff after the ward rounds and at the weekend to ensure no changes have been made.

Medication should continue to be dispensed from the drug trolley if, at any time, the patients own supply is not available.

M) Prior to discharge the patient is given a Personal Medication Record Booklet. This booklet is transcribed from the kardex by either a nurse or the pharmacist. The dose is written as mg/mcg not number of tablets ( i.e. 75 mg not 50 mg one tab, 25 mg one tab) The Tacrolimus/ Ciclosporin doses & blood levels are written in the centre of the book. The patient is reminded to bring the “green book” to out-patient appointments and use it when visiting their GP and pharmacist.

N) Top-up/ Newly prescribed drugs Order via one stop pharmacy

O) The tablets should be counted in to the locker and the number written in red on the compliance chart. New medication should be noted in the corresponding date column, as with the drug kardex.

P) On discharge the patient must have a 7 day supply of medication. A compliance check is carried out to assess the number of drugs the patient requires. The doctor completes an immediate discharge letter. Inform the pharmacist who will arrange the supply of the medication.

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Anaesthetic Protocol << >> Appendices

This page last modified 08.09.2009 14:48 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Pre-op assessment

Clinical assessment including current weight and usual post-dialysis weight FBC, U’s &E’s. Check that blood has been grouped and saved. All patients require basiliximab pre-operatively.

Fasting Patients should fast for four hours pre-op. Longer periods of fasting are neither necessary nor desirable.

DVT prophylaxis This includes subcutaneous heparin and compression stockings.

Potassium control Many patients are chronically hyperkalaemic and tolerate this well In general, aim for [K+] < 5.0 mmol/l-1 Mild hyperkalaemia may be treated with dextrose/insulin but K >5.5 is an indication for dialysis. See transplant work up protocol for more detail.

Pre-med

Benzodiazepine (at discretion of anaesthetist) Usual medication (except NSAIDs , diuretics and ACE - inhibitors) If gastro-oesophageal reflux, oral ranitidine.

Diabetic patients Diabetics are given 10% dextrose and insulin infusion throughout the peri-operative period with hourly blood sugar measurements. Good glycaemic control should be ensured.

Anaesthetic room

Do NOT use limbs with shunts for monitoring or IV access

Monitoring

ECG, SpO2, NIBP pre induction Triple lumen central line inserted after induction Arterial line not usually required: insert only if clear indication (Minimise damage to vessels which may be required for shunts)

IV access

peripheral cannula 14G or 16G dorsum of hand or forearm

Induction

Propofol or thiopentone Atracurium for muscle relaxation (Suxamethonium may be indicated, but this is unusual and carries risk of hyperkalaemia)

Antibiotics

Tazobactam/piperacillin 4.5g at induction For patients allergic to penicillin: Vancomycin 1 gram IV in Normal saline infused over 2 hours and Ciprofloxacin 400 mg infused over 60 mins.

DVT prophylaxis Minihep 5000U s.c. unless given on ward.

Theatre

Maintenance

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IPPV Isoflurane in oxygen/air or oxygen/nitrous oxide. Morphine for analgesia. Atracurium for muscle relaxation.

Temperature

All patients should have HME and warming mattress. All fluids should be given through a warmer.

Fluid and haemodynamic management Avoid hypotension (relative to patient’s normal BP) and hypovolaemia. In general aim for CVP ~ 10 mmHg. 0.9% saline is used for basal fluids, with colloids as required.

Treat hypotension with fluid challenge. Try to avoid use of vasoconstrictors.

Blood is not generally required.

Intravenous heparin approx. 3000 units may be given after discussion with the surgeon.

Reperfusion

Methylprednisolone 500 mg i.v.(to be given again 24 hour post transplant) It is particularly important to avoid hypovolaemia or hypotension at the time of reperfusion: fluid bolus may be required.

Recovery Neuromuscular block is reversed at the end of the operation and the patient extubated Analgesia: I.V. Fentanyl boluses as required, followed by PCA Fentanyl. Ensure minihep is prescribed.

Return to transplant unit The renal physician on call should be notified when the patient is leaving theatre and will meet the patient on return to the Transplant Unit. The anaesthetist should return to the Transplant Unit with the patient and handover to the renal physician on call. It is essential that there is no breakdown of communication at this stage.

Potassium is checked on return to the transplant unit.

Initial fluid replacement: 0.9% NaCl at previous hours urine output + 60 ml. Target CVP +5 – 11cmH2O. This is only a guide. The amount required depends on clinical assessment and CVP. Remember that oliguria may be secondary to hypotension and/or hypovolaemia. These must be avoided as they may contribute to the development of delayed graft function. Equally however fluid overload in the presence of anuria will cause pulmonary oedema

Note Diuretics (dopamine, mannitol, frusemide) are not given routinely intra or post-op.

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Complementary Medicines << >> Self-Administration

This page last modified 08.09.2009 14:45 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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There is currently insufficient information on the pharmacokinetics of complementary medicines to enable a judgement on whether they are likely to interact with conventional medicines and whether dosage reduction is necessary in renal impairment. Due to a lack of regulation, adverse effects such as nephrotoxicity may be attributable to impurities rather than the active principle.

Below is an extremely limited list of information on complementary medicines - for specific queries the Welsh Drug Information Centre specialist file and Micromedex may be consulted via pharmacy.

Complementary Issue Medicine

CyA levels reported due to CYP450 3A4 induction. May St John’s Wort therefore tacrolimus levels

Garlic Papaya Danshen ↑ INR therefore avoid peri-operatively Dong quai Ginger

Xaiochai hutang ↑ Prednisolone levels

Chinese herb (Aristolochia) Renal damage Juniper Pennyroyal

Ginko Cyclo-oxygenase inhibitor and PAF antagonist

Echinaecea ‘Immunostimulant’ - stimulates TNF secretion in vitro

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Vaccinations << >> Anaesthetic Protocol

This page last modified 08.09.2009 14:40 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Renal Transplantation Protocol: Immunisations 2009

Pre-Transplant Post-Transplant A. Killed Vaccines

- Tetanus / diphtheria / inactive polio1 Yes - Hepatitis B Yes Yes - Influenza Yes Yes - Typhoid (inactive polysaccharide vaccine) Yes Yes - Pneumococcal / Meningococcal / Hib Yes - Combined Hepatitis A/B (TWINRIX) Yes Yes

B. Live Vaccines Yes

- MMR2 Yes Contraindicated - Varicella Yes Not recommended - BCG Yes Contraindicated

- Yellow Fever Vaccine Yes Contraindicated

1. Oral/live polio vaccine not been usedin UK since 2004. 2. There is no risk of infection from vaccinees and susceptible contacts.

Measles - patients who are immunosuppressed and come into contact with measles should receive HNIG (human normal immunoglobulin) as soon as possible, but within 6 days.

Chickenpox - Varicella zoster immunoglobulin (VZIG) is indicated in patients who have had significant exposure to chickenpox or shingles and who have no antibodies to VZ. VZIG should be given within 7 days of contact.

Yellow Fever – patients post-transplant intending to travel to countries where a Yellow Fever vaccination certificate is mandatory should obtain a letter of exemption from a medical practitioner. (Yellow Fever occurs in tropical Africa and in South America – see WHO website for details.)

Malaria Prophylaxis – up-to-date information on Malaria prophylaxis for a given destination is available from pharmacy. The following table gives an indication of interactions:

Tacrolimus Ciclosporin Choloroquine ? ↑ tacrolimus (CP450 3A4) ↑ CyA (CP450 3A4) Proguanil No interactions likely No interaction likely Mefloquine ? ↑ tacrolimus (displacement from plasma protein) No interaction likely Doxycycline ? ↑ tacrolimus (CP450 3A4)

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PJP Treatment << >> Complementary Medicines

This page last modified 03.12.2009 10:35 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Pneumocystis jirovecii pneuomonia (PCP) Solid organ transplant unit guidance, RIE

Treatment of acute PCP

if Pa02 > 10 kPa oral therapy may be considered if Pa02 < 8 kPa then use IV all times initially if 02 saturation < 92% or PaO2 < 9.3 kPa on room air then consider steroids (see below)

Adjunctive Steroid Therapy If PaO2 <9.3 kPa (or SatnO2 <92%) on room air, give 60 mg prednisolone daily for 5 days, then 40 mg daily for 5 days and then 20 mg daily for 10 days (unless steroids are contraindicated). Steroids have been shown to improve survival and shorten duration of illness in HIV patients with PCP, but clear evidence for this benefit is not available in non-HIV patients with PCP.

First line treatment: Co-trimoxazole (Sulfamethoxazole and trimethoprim) Dose: 120mg/kg of co-trimoxazole per day in 2-4 divided doses, intravenously or orally (rounded to nearest 480mg) (usually around 14 vials over 24 hours or 1920mg/20mls in 500mls of 0.9% NaCl or 5% dextrose every 6 hours) or orally 1920 mgs qds. Adjust for creatinine clearance <30ml/min (See main AMT guideline or discuss with pharmacist)

After 7 days of iv therapy, or 3 to 4 days with the patient being clinically well, the treatment may be changed to oral but beware of nausea.

Creatinine and potassium levels should be monitored carefully, as these may rise in solid organ (esp renal) transplant patients on high dose co-trimoxazole. Confusion may sometimes occur. Monitoring co-trimoxazole levels is impractical due to turnaround times, however if there are concerns about side effects, then consider switching to second line treatment. Check G6PD status early on (EDTA tube to haematology) as second line therapy will often be required. Total duration of treatment: 3 weeks

IV regimen of co-trimoxazole for PCP Dosage using vials of 480 Weight mg/5ml 30-40 kg 9 vials/24 hrs 40-50 kg 11 vials/24 hrs 50-60 kg 14 vials/24 hrs 60-70 kg 16 vials/24 hrs 70-80 kg 19 vials/24 hrs

It is important that the patient receives ~ 2 litres of 0.9% NaCl over 24 hrs. If creatinine clearance is <30mls/min dose reduction is required (See AMT guideline or discuss with pharmacist).

Second line treatment for PCP: Clindamycin and Primaquine Clindamycin 450mg 6 hourly (IV or orally) and Primaquine 15 mg/day orally. Common side effects are nausea, diarrhoea, vomiting, abdominal pain, rashes, methaemaglobinaemia and haemolytic anaemia. Methaemoglobinaemia may present as increased SOB or an apparent worsening of the PCP. If this occurs check levels with haematology. Caution with G6PD deficiency (check levels). If diarrhoea occurs test for C. difficile and start oral vancomycin 250mgs 6 hourly.

Alternative second line treatment Please discuss with microbiology or infectious diseases if alternative regimen is required. IV pentamidine (4mg/kg once daily) for severe disease or oral atovaquone (750 mg bd) for mild/moderate disease are alternative options for second line treatment.

Infection control: There is some evidence of possible spread amongst immunocompromised patients. Patients with PCP should therefore be placed in a sideroom, preferably off the transplant unit for the first 5 days of PCP treatment if feasible.

Treatment recommendations are adapted for solid organ transplant unit from previous RIDU House Manual 2012, discussions with ID Team and local Transplant unit experience, see: British HIV Association Opportunistic Infections Guidance: http://www.bhiva.org/OI2011.aspx

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Acknowledgements: IF Laurenson, KO Helgason, S Watson (Consultants) and K Davidson (Pharmacist) were the main authors for this page. The last modified date is shown in the footer and this page will be reviewed in May 2015.

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PJP Prophylaxis << >> Vaccinations

This page last modified 02.08.2013 14:08 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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PNEUMOCYSTIS jerovicii PROPHYLAXIS (Note: New name for PCP)

First Line Co-trimoxazole 480mg od

If documented allergy to co-trimoxazole consider desensitisation regimen as soon as patient able to tolerate oral medicines post-transplant:

Day Preparation Dose

1 Co-trimoxazole suspension 2.4mg/mla 1ml

2 2ml 3 4ml 4 8ml 5 12ml

6 Co-trimoxazole suspension 2mg/mlb 1.25ml

7 2.5ml 8 5ml 9 10ml 10 Co-trimoxazole 480mg tablet ONE

a Co-trimoxazole paediatric suspension 240mg/5ml diluted 1:20 b Co-trimoxazole paediatric suspension 240mg/5ml undiluted

Second Line Dapsone 100mg od

Consider dose reduction to 50mg od in severe renal dysfunction (creatinine clearance <10ml/min)

Third Line Nebulised pentamidine 300mg every 4 weeks – refer to following guidelines for details of administration.

Administration of Nebulised Pentamidine

Equipment Pentamidine nebuliser solution 300mg x 1 Salbutamol 2.5mg/2.5ml nebule x 1 NaCl 0.9% 5ml x 1 Nebuliser compressor ISO-NEB Filtered Nebuliser System (Ref 41755) and elephant tubing for pentamidine Nebulising chamber and mask for salbutamol Apron Pair of Safeskin-Purple Nitrile gloves P1 type mask Pair of goggles “Do not enter” sign

Method

1. Put patient in dedicated room with window to outside and closed door. Place “Do not enter” sign on outside of door informing others not to enter. 2. Administer salbutamol nebule as per usual practice. 3. Put on apron, gloves, mask and goggles.

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4. Prepare nebulising equipment for administration of pentamidine. 5. Connect ISO-NEB Filtered Nebuliser System to compressor. 6. Place elephant tubing out of open window. 7. Draw up pentamidine nebuliser solution and add to chamber of ISO-NEB Filtered Nebuliser System. 8. Instruct patient to form a tight seal around mouthpiece during administration and to switch compressor off during treatment if mouthpiece needs to be removed from mouth. 9. Leave the room. 10. Indicate to patient to start compressor. 11. If patient is unable to start compressor by his/herself then start it for him/her and leave the room immediately. 12. Check patient every 5 minutes for 20 minutes until nebulisation complete. If there is any need to need to enter the room during administration put on apron, gloves, mask and goggles before entering and switch off the compressor immediately after entering. 13. Indicate to patient to switch off compressor and leave room, closing door behind. 14. DO NOT enter room for at least 2 hours after completion of nebulised pentamidine. 15. Enter room and dispose of nebulising equipment in orange clinical waste bag inside room.

Reference Source Electronic Medicines Compendium

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HUS and TMA << >> PJP Treatment

This page last modified 02.08.2013 13:43 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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DRAFT - March 2011

Thrombotic microangiopathy (TMA) (or haemolytic uraemic syndrome, HUS) is an occasional post-transplant occurrence. When it occurs consider:

Could HUS have been the primary diagnosis? Send complement level assays before plasma exchange Take DNA for complement genotyping Immunosuppression - difficult early post transplant, no calcineurin inhibitor is certain to be safe. Azathioprine, MMF can be regarded as safe, but position for ATG, OKT3 and sirolimus is uncertain too, these have also been implicated in causing small vessel thrombi. Consider eculizumab If live donor, consider high risk to the donor of developing the same problem

Alternative explanations for TMA might include antibody-mediated or vascular rejection, or possibly calcineurin inhibitor toxicity. Ischaemia/reperfusion may trigger TMA in susceptible individuals or be one of several 'hits' to the endothelium.

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CMV << >> PJP Prophylaxis

This page last modified 16.03.2011 17:30 by ANT. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Valganciclovir

Criteria for patient selection

For prevention of CMV disease in high risk transplant patients identified as follows:

Renal and Simultaneous kidney-pancreas transplant (SKP) - All transplant recipients except CMV –ve recipients of CMV –ve donors

Valganciclovir has replaced Ganciclovir for prevention of CMV disease. Prescriptions will be initiated in hospital within 10 days of transplantation. Therapy will be continued in primary care for up to a total of 180 days treatment for which a shared-care protocol will be provided.

The initial valganciclovir dose is dependent on renal function as shown in the table below:

Creatinine clearance Prophylactic dose (ml/min) >60 900mg od 40 to 59 450mg od 25 to 39 450mg every 2 days 10 to 24 450mg twice weekly 100mg three times weekly after <10 dialysis

Valganciclovir is available as 450mg tablets (pink) or as an oral solution and the brand name is Valcyte . The tablets should be taken with food and not broken or crushed.

FBC and LFTs must be monitored daily during therapy. Leucopenia can occur with valganciclovir treatment and this is a common cause for discontinuing the drug prematurely.

Note: Surveillance for CMV post - transplant is not performed routinely in the Unit.

Investigation of any episode of illness which might be CMV related, at any stage following a transplant operation.

An EDTA (9 ml or 3 x 2.5 mls sample for CMV should be sent to Virology whenever is clinically relevant. ON request form include details of illness (e.g. pyrexia or hepatitis etc.) Request CMV PCR and CMV culture. Please try to ensure samples reach Virus Lab by midday. The rapid culture may provide an answer sooner than PCR in some cases.

It will often be appropriate to send respiratory or other samples to virology - bronchoalveolar lavage or induced sputum for investigation as usual or colon biopsies.

Treatment of CMV disease

Patients in whom the diagnosis of CMV disease has been made with positive CMV PCR should be treated with 2 weeks IV ganciclovir followed by oral valgangiglovir. This should be continued until two consecutive negative CMV results have been obtained.

Dose of IV gancyclovir will depend on creatinine clearance:

Creatinine clearance (ml/min) Prophylactic dose >70 5mg/kg every 12 hours 50 to 69 2.5mg/kg every 12 hours 25 to 49 2.5mg/kg/day 10 to 24 1.25mg/kg/day <10 1.25mg/kg/day after haemodialysis

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Renal Allograft Biopsy << >> HUS and TMA

This page last modified 03.12.2009 10:33 by Emma Farrell. www.edren.org is produced by staff of the Renal Unit at the Royal Infirmary of Edinburgh. Please exercise caution in interpreting the information published here, we are fallible and do make mistakes, and written info cannot substitute for expert medical advice. We regret that we cannot give remote advice on the management of individual patients. More about edren, including our confidentiality and privacy policy. Let us know of anything that could be better: contact us. Design modified from an original by Andreas Viklund. This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 UK: Scotland Licence (more info)

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Renal allograft biopsies are usually performed under USS guidance in x-ray department by the radiologist. If it is a non urgent biopsy the request should be made on TRAK. Urgent biopsy requests should be discussed with a Consultant Radiologist.

All patients must have:

1. Consent

must be obtained by the doctor performing the biopsy. patients informed of risks:

- significant bleeding (requiring blood transfusion / further surgical intervention) is approximately 1-2%.

- the risk of graft loss is <1 in 250 biopsies

2. Clotting screen

For biopsy to proceed results required:

- blood pressure - platelets > or = to 60 x 109L. - PT - prolongation of < 3 seconds. - if patient on Warfarin an INR of < or = 1.5. APTT normal. - Group and save.

3. FBC

4. Heparin discontinued

5. Aspirin / Warfarin discontinued.

6. Oral Fluids only

7. 10mls clotted blood sample for HLA antibodies should be sent to the BTS lab.

Results and Pathology Form must be attached to front of case notes for the attention of radiologist (if samples are required for EM and immunofluorescence then this must be clearly indicated on the request card. These are required if de novo / recurrence of a primary glomerulonephritis is suspected).

Pathology Department contacted and told of the biopsy and arrangements made to collect the specimens.

Pathology request forms:

Must be filled in by the doctor requesting the biopsy.

Clinical problem stated on the form.

Unless otherwise stated it will be assumed that samples for light microscopy and frozen section are required.

If sample for immunofluorescense or electron microscopy is required this must be stated on the form.

Request form must be attached to the front of the case notes.

Dr. Chris Bellamy (bleep 5044 or tel. 27150) and Professor David Harrison (contact through switchboard) are the contacts for pathology.

Weekend on call Pathologist can be contacted via RIE switchboard.

Post biopsy observations should be recorded - every 15 mins for first 30 mins, every 30 mins for 2 hours, 4 hourly.

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Biopsy results must be documented in the patient’s case notes and on Proton problem list/ transplant screen (when available).

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Treating rejection << >> CMV

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