SOMATROPIN ( Genotropin, Humatrope, Norditropin,

Transcription

1 Shared Care Guidelines DRUG: SOMATROPIN ( Genotropin, Humatrope, Norditropin, Saizen and Omnitrope ) (Adults) Introduction: Indication: Growth hormone deficiency in adults Dosage & administration: micrograms daily by subcutaneous injection, gradually increased to a maximum of 1mg daily (requirements may decrease with age) Formulations: Products available: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen and Zomacton See BNF for details of all The specialist will clearly state the dose and product for each individual. Where a separate pen device is required for administration of injection cartridges this will be provided by the clinic as the pens are not prescribable on the NHS. Contraindications & Warnings: Interactions: Cautions Diabetes mellitus, insulin dependant patients may require dose adjustment. Secondary care with monitor HbA1C and blood glucose Papilloedema- fundoscopy recommended Relative deficiencies of other pituitary hormones notably hypothyroidism- secondary care with monitor thyroid function tests. History of malignant disease Disorders of the epiphysis of the hip - monitor for limping Resolved intracranial hypertension- monitor closely. Contra-indications Hypersensitivity to the active substance or to any of the excipients. Pregnancy and breast feeding. Evidence of tumour activity, (complete antitumour therapy and ensure intracranial lesions inactive before starting). Not for use after renal transplantation. Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated Corticosteroids - Growth promoting effect of somatropin may be inhibited by doses of corticosteroids above replacement doses. Oestrogens - Increased doses of somatropin may be needed (when Name: SOMATROPIN Shared Care Guideline Page 1 of 5

2 oestrogens are used as an oral replacement therapy) Antidiabetics - somatropin may reduce insulin sensitivity causing hyperglycaemia and increase the risk of insulin resistance. Insulin doses and doses of oral agents may need adjusting after somatrotropin therapy is introduced. Secondary care will make any adjustments necessary Drugs metabolised by CYP3A4 (e.g anti-epileptics,ciclosporin and corticosteroids and sex hormones) - Somatropin may theoretically increase the clearance of these drugs and reduce their levels, but clinical significance unknown Adverse Effects: Headaches / Papilloedema- Headache may be noted transiently in some patients on higher dosage regimens. Rarely benign intracranial hypertension has been observed in some patients. Fundoscopy is therefore recommended if severe or recurrent headaches, visual problems, nausea and vomiting to check if papilloedema is present and help confirm the diagnosis. In such cases refer patient back to the specialist who will arrange Ophthalmological review Fluid retention, arthralgia, carpel tunnel syndrome- usually dosedependant, consider reducing the dose Hypothyroidism- Secondary care will monitor thyroid function tests Insulin resistance, hyperglycaemia, hypoglycaemia- Insulin dose or those of oral agents may need adjusting. Secondary care will make any adjustments necessary Antibody formation has been reported but seldom clinically relevant. Reactions at injection site- Local discomfort at the site of injection, and frequent subcutaneous injections into the same site may result in tissue atropy. Injection sites should therefore be rotated. of the specialist initiating treatment: General: To assess the suitability of the patient for treatment, ensuring they meet the standards in NICE guidance Somatropin for adults with growth hormone deficiency (TA 64 Aug 2003) To ensure that the patient/carer has received counselling and understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects, and is aware of actions to take if adverse effects are suspected. Teach injection technique (or arrange for the manufacturer to teach injection technique) When secondary care is doing the initial injection technique training issue the patient with their first sharps bin Inform the GP of the information provided to the patient To review the patient as agreed intervals and copy any relevant results to the GP Name: SOMATROPIN Shared Care Guideline Page 2 of 5

3 Carry out disease and drug monitoring as listed below Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care. Prescribing: Prescribe growth hormone for the first 3 months of treatment Ensure that the patient and/or carer receives the right device and the education in using and storing the medication (most somatropin medication preparations need to be kept in the refrigerator) by an appropriate medical professional. Monitor bloods according to schedule: Insulin like growth factor (IGF1) Baseline and at every clinic visit which will be 3-12 monthly dependant upon patient and duration of treatment Liver Function test Thyroid function tests Luteinising Hormone Follicle Stimulating Hormone Prolactin Cortisol HbA1C Baseline and then annually of other prescribers: Discuss shared care arrangement with patient Support and advise GPs as required Assess response to treatment and initiate any dose changes as clinically appropriate according to symptoms present and an IGF-1 (Somatropin should be discontinued if the quality of life has not improved sufficiently by 9 months this is assessed as per NICE guidance ) General and Prescribing: Reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Prescribe as recommended by the specialist. The GPs will be asked to take up the prescribing of somatropin 3 months after initiation. Note - the manufacturer will issue sharps bins to a patient (or carer). Notify Consultant if treatment with somatropin is discontinued. Ensure there are no drug interactions with any other medications initiated in primary care. Secondary care will normally carry out all routine blood monitoring as listed above. GP to monitor for side effects, drug interactions etc. To refer back to the specialist if the patient s condition deteriorates. Name: SOMATROPIN Shared Care Guideline Page 3 of 5

4 Stop treatment on the advice of the specialist. Withhold or discontinue treatment with somatropin when necessary and refer to the specialist when judged clinically appropriate by the GP e.g symptomatic or severe adverse effects. Identify adverse effects if the patient presents with any signs and liaise with the hospital specialist where necessary. To report adverse effects to the specialist and where appropriate to the Commission on Human Medicines/MHRA (Yellow Card scheme). Monitoring If patients presents with severe or recurrent headache, visual problems, nausea and/or vomiting fundoscopy for papilloedema is recommended to exclude a diagnosis of benign intracranial hypertension. Refer patients with these symptoms back to the specialist who will arrange for ophthalmological review. of the Patient / Carer: Communication: General : To choose a device suitable for their needs. To undertake education in self injection or injection on behalf of patient. Training will be provided by secondary care or the manufacturer. To have an understanding of the use and storage of the medication and the side effects. To dispose of any needles and used injections in an appropriate sharps bin. The first sharps bin will be provided by the person carrying out initial injection technique training (either secondary care or the manufacturer). Subsequent bins will be provided by the manufacturer. Contact the local council to arrange for disposal of waste contained in sharps bin or alternatively return to the person who issued the sharps bin. To have understanding in the use and storage of the medication and the side effects. To report any concerns or side effects to relevant medical professional including Consultant, GP, SpR or Endocrine Nurse. Ensure they have adequate supply of medication. Attend appointments. As above contact GP or initiating team if side effects develop (see adverse effects) and attend appointments including those for routine blood tests/investigations Specialist to GP: The specialist will inform the GP when they have initiated somatropin and when there are any subsequent changes in treatment standard clinic letter Send a copy (either electronically or paper copy) of the Shared Care Guideline to the GP and ask whether they are willing to participate in shared care Name: SOMATROPIN Shared Care Guideline Page 4 of 5

5 Inform the GP of the information provided to the patient. GP to Specialist: To reply to the request for shared care within 2 weeks of receipt of the Consultant letter. Irrespective of whether you accept prescribing responsibility or not, you should inform the consultant of relevant medical information regarding the patient and changes to the patient s medication regime irrespective of indication Notify Consultant if treatment with somatropin is discontinued. Contact names & details: If you have any concerns regarding individual patients, see consultant letter for medical contact details or contact one of the following: Name Title/Location Telephone / Bleep Dr P Jennings Consultant Endocrinologist Dr J Thow Dr V Jayagopal Consultant Endocrinologist. Consultant Endocrinologist Ottilia Buch Specialist Endocrine Nurse Scarborough Endocrinology secretaries Dr David Humphriss, Dr Tadeusz Pawlak Costs: Cost of individual products can be accessed via the BNF 1. Summary of Product Characteristics - Updated Genotropin References: (2.4.12) Humatrope ( ) Norditropin ( ) Omnitrope ( ) Saizen (2.5.12) 2. BNF March NICE TA 64 Aug 2003 Document Control: This information is not inclusive of all prescribing information and potential adverse effects. Please refer to the SPC (data sheet) or BNF for further prescribing information. The original Microsoft Word file of this document is located on: Teaching Hospital NHS Foundation Trust Pharmacy Department X:\MEDICINES INFORMATION\Shared Care Guidelines\Approved Shared Care Guidelines\SOMATROPIN Shared Care Guideline V1.0 Shared Care Guidelines are available electronically via Prepared by: Checked by: Eunice Barry, Endocrine Specialist Nurse Jane Crewe (Pharmacist YH) Diane Tomlinson (Pharmacist NY and Humber Commissioning Support Unit) Version: 1.0 Date of Issue / Review: November 2013 Date for next Review: November 2015 Approved by: Drug & Therapeutics Committee November 2013 Name: SOMATROPIN Shared Care Guideline Page 5 of 5