Hull & East Riding Prescribing Committee
Somatostatin analogues (Somatuline LA, Somatuline Autogel and Sandostatin LAR)
Patient’s Name: ……………………………………………. NHS Number: ………………
Patient’s Address: …………………………………………..(Use addressograph sticker)
GP’s Name:……………………………………………………….……..
We agree to treat this patient within this Prescribing Framework
Specialist Prescriber’s Name……………………………………… Prof Reg. No: .…………
Specialist Prescriber’s Signature: ………………………………… Date: ……………………
Where prescriber is not a consultant:
Consultant’s Name: ………………………………………………… GMC No: ……………….
Consultant’s Signature: ………………………...... ………………… Date: ……………………
GP’s Signature: ……………………………………………………… Date: ……………………
GP’s Name (if different from listed above): ……………………………………..
Communication
The front page of this form should be completed by the specialist and the form sent to the patient’s general practitioner.
The patient’s GP should sign and send back to specialist, to confirm agreement to enter into shared care arrangement. If the General Practitioner is unwilling to accept prescribing responsibility for the above patient the specialist should be informed within two weeks of receipt of this framework and specialist’s letter.
Prescribing framework for Somatostatin analogues Date ratified by the HERPC: July 2016 Updated May 2019 Review: May 2022 Page 1 of 4 Hull & East Riding Prescribing Committee 1. BACKGROUND
Secretion from many endocrine tumours is inhibited by natural somatostatin. Octreotide is a long- acting analogue of somatostatin which is effective in reducing growth hormone secretion in patients with acromegaly, and peptide hormone secretion from gastroenteropancreatic and carcinoid tumours.
In its native form octreotide is an octapeptide analogue of somatostatin administered by subcutaneous injection. Biological response is maintained for at least 8 hours following injection. A high percentage of patients currently prescribed subcutaneous octreotide find three injections unacceptable contributing to poor compliance (up to 50% of patients) with the additional problem that hormonal control escape may occur overnight. Three depot Octreotide analogues are available, Lanreotide (Somatuline LA) 30mg which is given every 10-14 days, Lanreotide (Somatuline Autogel) 60/90/120mgs given every 28 days, and Octreotide LAR (Sandostatin LAR) 10/20/30mg given every 28 days. Maximal inhibition of hormone secretion is usually achieved in 24 to 48 hours.
However there is often increasing resistance to octreotide over time, particularly in patients with malignant tumours, probably due to receptor down-regulation. At least 70% of growth hormone secreting adenomas and between 30 and 90% of gastroenteropancreatic tumours, depending on type, respond to octreotide.
This document should be read in conjunction with the guidance “Responsibility for prescribing between Primary & Secondary/Tertiary Care” https://www.england.nhs.uk/wp- content/uploads/2018/03/responsibility-prescribing-between-primary-secondary-care-v2.pdf
2. INDICATION
Symptoms associated with carcinoid tumours with features of Carcinoid Syndrome, VIPomas, Glucagonomas, Acromegaly and prevention of complications following pancreatic surgery.
3. DOSE
Acromegaly Lanreotide (Somatuline Autogel) initially usually 60mg, every 28 days by deep subcutaneous injection into the gluteal region, dose adjusted according to response, to a maximum dose of 120mg every 28 days. Higher doses and/or increased dosing frequency may be required in some cases and this is off-licensed use.
Octreotide (Sandostatin LAR) initially usually 20mg, given every 28 days by deep intramuscular injection into the gluteal muscle, dose adjusted according to response, to a maximum dose of 40mg every 28 days. Higher doses and/or increased dosing frequency may be required in some cases and this is off-licensed use.
Neuroendocrine tumours Lanreotide (Somatuline Autogel) initially usually 60mg, every 28 days by deep subcutaneous injection into the gluteal region, dose adjusted according to response, to a maximum dose of 120mg every 28 days. Higher doses and/or increased dosing frequency may be required in some cases and this is off-licensed use.
Octreotide (Sandostatin LAR) initially usually 20mg, given every 28 days by deep intramuscular injection into the gluteal muscle, dose adjusted according to response, to a maximum dose of 30mg every 28 days. Higher doses and/or increased dosing frequency may be required in some cases and this is off-licensed use.
Short acting Octreotide
Prescribing framework for Somatostatin analogues Date ratified by the HERPC: July 2016 Updated May 2019 Review: May 2022 Page 2 of 4 Hull & East Riding Prescribing Committee The patient may also require rescue short acting subcutaneous somatostatin analogue treatment for their breakthrough symptoms. A rescue dosage schedule of Octreotide is between 50-500 micrograms three times daily in neuroendocrine tumours. Patients will be self taught to administer the drug by subcutaneous injection and the drug efficacy will be assessed by the clinical, biological and biochemical response.
4. DURATION OF TREATMENT
Will be advised by Consultant Endocrinologist/Oncologist may be long-term.
5. ADVERSE EFFECTS
Octreotide inhibits many gastrointestinal functions. The commonest side effects are thus steatorrheoa due to inhibition of pancreatic enzyme secretion and gallstone formation due to biliary stasis; gallstones are a potential contra-indication to use of the drug. Steatorrheoa may be overcome by the use of pancreatic enzyme supplements.
Due to its inhibitory action on growth hormone, glucagons and insulin release, octreotide may affect glucose regulation. Post prandial glucose tolerance may be impaired. In some instances a state of persistent hyperglycaemia and diabetes mellitus may be induced as a result of chronic administration. Hypoglycaemia has also been observed. In patients with concomitant Type I diabetes mellitus, Sandostatin LAR is likely to affect glucose regulation, and insulin requirements may be reduced.
For further information see www.bnf.org or www.medicines.org.uk)
6. INTERACTIONS
Lanreotide and Octreotide reduce plasma concentration of ciclosporin
For full list see www.bnf.org or www.medicines.org.uk.
7. MONITORING
Efficacy of treatment is determined by the clinical and biochemical response and to a lesser extent by change in tumour size.
Annual HbA1c level in patients without diabetes mellitus.
8. INFORMATION TO PATIENT
Patients will be educated as to the condition of which they suffer and advised about symptoms and side effects of Octreotide depot treatments. They have access in office hours to the Endocrinology Specialist Nurse for ongoing queries and support. Written support information is available from the Pituitary Foundation (www.pituitary.org) and the NET Patient Foundation (www.netpatientfoundation.com) and will be given to the patient if they wish to receive it.
Prescribing framework for Somatostatin analogues Date ratified by the HERPC: July 2016 Updated May 2019 Review: May 2022 Page 3 of 4 Hull & East Riding Prescribing Committee 9. RESPONSIBILITIES OF CLINICIANS INVOLVED
Stage of Hospital Specialist/Endocrinology General Practitioner Treatment Specialist Nurse Initiation Prescribe drug and monitor therapy until treatment and dose are stabilised (usually between one to three months)
Communicate with GP regarding diagnosis, drug name, strength and frequency.
Provide patient with information on diagnosis and treatment.
Maintenance Advise GP on need for pancreatic enzyme Prescribe ongoing treatment, including supplements pancreatic enzyme supplements, if advised by consultant. Arrange abdominal ultrasound for monitoring if indicated Prescribe subcutaneous octreotide as an adjunct to maintenance preparation when Train patient/carer on administration, required for breakthrough symptoms where the patient wishes to self/carer administer (Lanreotide Autogel only). Arrange SC administration by practice nurse (see information on administration on PIL Provide support materials and training and SPC) where needed on administration to GP Practice Nurses/Nurse Practioners. To organise an HbA1c level every 12 months in patients without diabetes mellitus. Offer patient the option of homecare delivery service and/or ongoing Monitor for adverse effects. administration of therapy with the homecare service nursing team. Phlebotomy for blood tests and urine collections may be needed to optimise efficacy of tests or for patient convenience.
Contact Details:
During Office hours: Consultant Endocrinologist on 01482 675367/675369 Endocrinology Specialist Nurse on 01482 675360
Out of hours: On-call Endocrinology Consultant or Registrar via HRI Switchboard (01482 875875).
APPROVAL PROCESS
Written by: Prashanth Takkallapally, Specialist Pharmacist – Endocrinology Professor T Sathyapalan, Senior Lecturer/Honorary Consultant, Endocrinology Leanne Ward, Endocrinology Specialist Nurse Consultation process: HUTH specialist team in Endocrinology and Oncology Approved by: MMIG Ratified by: HERPC July 2016 Updated May 2019 Review date: May 2022
Prescribing framework for Somatostatin analogues Date ratified by the HERPC: July 2016 Updated May 2019 Review: May 2022 Page 4 of 4