TRAFFORD MEDICINES MANAGEMENT GROUP
SHARED CARE GUIDELINE for Denosumab for Reference Number Osteoporosis NP071
Scope: Denosumab for Osteoporosis treatment Classification SHARED CARE GUIDELINE Issue date: February 2012 Replaces: New Author(s)/Originator(s) P Shah , Consultant Rheumatologist To be read in conjunction with the Pharmaceutical company’s patient information following documents leaflet (PIL) Summary of product characteristics (SPC) Authorised by Medicines Management Date: Jan 2012 Committee Review Date January 2017
1. Introduction Patients with osteoporosis are at increased risk of fractures. Denosumab significantly reduces the risk of vertebral, non vertebral and hip fractures. This has been demonstrated in post-menopausal women and in men with bone loss secondary to hormone deficiency
2. Scope
Shared care may be appropriate in the following situation:
Patients with osteoporosis who have been referred to secondary care for assessment and recommendation of a treatment regimen.
Osteoporosis treatment with Denosumab recommended by the secondary care clinician and a treatment outline defined for that particular patient, communicated to the GP and kept under regular review.
N.B. Where “consultant” is referred to throughout this document, a designated deputy may undertake the role depending on the systems in place.
Shared care must be agreed before the patient is directed to primary care. Patients must not be put in a position where they are unsure where to obtain supplies of their medication. In the event that a GP declines to take on shared care of a patient, the matter will be resolved by the PCT.
0c4497abd560a8eb9401238a53386e69.doc Page 1 of 6 Approved by Medicines Management Committee Jan 2012 Review date: Jan 2014 ** CHECK THE INTRANET TO ENSURE YOU ARE USING THE MOST RECENT VERSION ** 3. Clinical condition being treated
Primary or secondary osteoporosis, as defined by the Consultant to whom the patient is referred
4. Product information and treatment regimen to be used
Dose of 60mg administered as a single Subcutaneous injection once every 6 months into the thigh, abdomen, or back of arm
5. Regimen Management
Aspects of care for which the Consultant is responsible
The consultant will confirm the patient’s diagnosis and carry out any baseline tests necessary.
The consultant will ensure that the patient is educated and provided with written information about their treatment and the importance of treatment and compliance
The consultant will initiate Denosumab and prescribe for the first TWO injections, which are 6 months apart. Any intolerance or side effects should be clearly communicated to the GP
The consultant will determine whether shared care is appropriate for the patient’s condition and will contact the GP.
The consultant will issue the patient with a letter informing them of the shared care process. The GP is responsible for continuing the prescription and making provision for administration of the SC injection in the community.
The GP must ensure the patient is adequately supplemented with Calcium and Vitamin D.
The consultant will provide the patient’s general practitioner with the following information:
o Diagnosis of the patient’s condition with the relevant clinical details.
o Details of any treatment to date and treatments to be provided to the GP.
o A copy of this guideline when the drug is commenced.
0c4497abd560a8eb9401238a53386e69.doc Page 2 of 6 Approved by Medicines Management Committee Jan 2012 Review date: Jan 2014 ** CHECK THE INTRANET TO ENSURE YOU ARE USING THE MOST RECENT VERSION ** Whenever the consultant sees the patient, he/she will send a written summary within 14 days to the patient’s GP. Urgent information will be given to the patient to take to the practice.
The consultant or his representative will be available for information or advice to the GP.
The consultant will ensure that the patient is given the appropriate appointments for secondary care follow up and that defaulters from follow up are contacted to arrange alternative appointments.
Aspects of care for which the GP is responsible
Ensuring that he/she has sufficient information and knowledge to understand the therapeutic issues relating to the patients clinical condition.
Agreeing to the principles & responsibilities of this shared care agreement. Agreeing that in his/her opinion a particular patient should receive shared care for the diagnosed condition unless good reasons exist for the management to remain within secondary care.
Producing all prescriptions in an accurate, legible form according to the guidance in the current BNF. It is important to stress that the individual signing a prescription carries the legal liability for the consequences of prescribing the drug.
Following initiation of Denosumab treatment by the consultant, prescribing treatment on the recommendation of the consultant and continuing therapy in accordance with advice from the supervising consultant.
Keeping a copy of the shared care agreement in the practice.
Reporting any adverse effects in the treatment of the patient to the consultant.
A system should be in place to ensure detection of non-attendees.
Aspects of care for which the patient or carer is responsible
Making appointments and attending for injections at the advised intervals.
Attending for monitoring and follow up in primary and secondary care as required and rearranging appointments if unable to attend for whatever reason.
Reporting of any side effects to their GP
0c4497abd560a8eb9401238a53386e69.doc Page 3 of 6 Approved by Medicines Management Committee Jan 2012 Review date: Jan 2014 ** CHECK THE INTRANET TO ENSURE YOU ARE USING THE MOST RECENT VERSION ** Informing their GP and consultant of any other medication they may be taking including products purchased “over the counter” and herbal medicines.
Ensuring they have a clear understanding of their treatment.
6. Summary of cautions, contra indications, side-effects No adjustment is required for patients with renal impairment or in elderly patients. Ensure hypocalcaemia is corrected before use. Monitoring of patients at risk of hypocalcaemia is recommended e.g. patients with severe renal impairment. Contraindicated in patients with hypocalcaemia and known allergy to the active substance or any of the excipients (patients with rare fructose intolerance).
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving Denosumab. Known risk factors include: Cancer with bone lesions, concomitant therapies (inc. chemotherapy, antiangiogenic biologics, corticosteroids, radiotherapy to head and neck) , poor oral hygiene, dental extractions, co-morbidities ( pre-existing dental disease, anaemia, coagulopathy, infection) and previous treatment with bisphosphonate.
7. Special considerations Consider appropriate preventative dentistry prior to treatment in patients with concomitant risk factors. In at risk group, avoid invasive dental procedures if possible whilst on drug . Not recommended in pregnancy Avoid breast feeding whilst taking Denosumab
8. Back-up care available to GP from Hospital, including emergency contact procedures and help line numbers
Advice should be available from the hospital trust, both from the consultant and more junior medical staff and from nurse practitioners where appropriate. The hospital trust will lead or participate in educational sessions for GPs and practice nurses where appropriate.
Queries regarding treatment may be directed where appropriate to the hospital trust’s Medicines Information Department.
Trafford Healthcare NHS Trust Contacts:
Consultant rheumatologists: 0161 746 2395
Rheumatology helpline (answer phone – calls normally answered within 24 hours) 0161 746 2162 0c4497abd560a8eb9401238a53386e69.doc Page 4 of 6 Approved by Medicines Management Committee Jan 2012 Review date: Jan 2014 ** CHECK THE INTRANET TO ENSURE YOU ARE USING THE MOST RECENT VERSION ** 9. Statement of agreement
Shared care is an agreement between the GP and the Consultant. This form is a request by the consultant to share the suggested care pathway of your patient. If you are unable to agree to the sharing of care and initiating the suggested medication, please make this known to the consultant within 14 days, ideally stating the nature of your concern.
10.Written information provided to the patient
Written information can be downloaded as a PDF leaflet from the National Osteoporosis website. The most common side effects are urinary tract infection, chest infection, cataract, constipation, rash, sciatica and limb pain. Patients receiving denosumab may uncommonly develop skin infections (predominantly cellulitis). Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Your doctor may recommend blood tests prior to the injection to check that your blood calcium levels are not too low and your kidneys are functioning correctly. A rare adverse effect called osteonecrosis of the jaw (ONJ) has been linked with this treatment.
0c4497abd560a8eb9401238a53386e69.doc Page 5 of 6 Approved by Medicines Management Committee Jan 2012 Review date: Jan 2014 ** CHECK THE INTRANET TO ENSURE YOU ARE USING THE MOST RECENT VERSION ** Denosumab
Dose regimen: 60mg in single SC injection in prefilled syringe, once every 6 months
Hospital: To initiate and prescribe first 2 doses of treatment
GP: To take over prescribing and administration thereafter
Pre-treatment assessment:- Calcium level
Monitoring:- Bone Mineral Density no more than 2-3 yearly ,at the discretion of the Consultant
Pregnancy and breastfeeding:- The manufacturer advises animal studies suggest risk of poor dentition and brown growth in foetus, so avoid in pregnancy. Unknown whether drug is excreted in breast milk and thus avoid in breastfeeding.
See manufacturer’s summary of product characteristics for further information.
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