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GREATER MANCHESTER INTERFACE PRESCRIBING GROUP On behalf of the GREATER MANCHESTER MEDICINES MANAGEMENT GROUP Reference Number SHARED CARE GUIDELINE for Growth Hormone in GROW 03 fnl Adults Scope: Growth Hormone for the treatment of pronounced Classification growth hormone deficiency in adults SHARED CARE GUIDELINE Issue date Replaces October 2003 version Author(s)/Originator(s) Manchester Prescribing Strategy Group To be read in conjunction with the following documents Pharmaceutical company’s patient information leaflet (PIL) Summary of product characteristics (SPC) Interface Prescribing Group Date October 2003 October 2005 Authorised by Review Date 1. Introduction These guidelines will look at the shared care management of pronounced growth hormone deficiency in adults. 2. Scope Growth hormone may be considered for shared care arrangements for the treatment of pronounced growth hormone deficiency in adults. This SCG has been updated to include the following guidance; “Prescribers are reminded that NICE technology appraisal no. 64 (2003) recommends continuation of therapy only if there is a satisfactory effect on patient quality of life after nine months of treatment, as defined in the above NICE TA. Shared care should not be sought until continuation of therapy has been confirmed. This 9 months assessment should be carried out by a consultant endocrinologist with a special interest in the management of growth hormone disorders prior to maintenance treatment being prescribed under a shared care agreement.” (Inserted by Interface group March 2008) 3. Clinical condition being treated The majority of adult patients with adult onset GHD have a pituitary adenoma or hypothalamic tumour or have received treatment for such a lesion with surgery and/or irradiation. In addition there are patients who had GHD diagnosed during childhood. In these patients GHD may be idiopathic or may be a consequence of a hypothalamic tumour or may GROW 03 fnl follow cranial irradiation for treatment of a cranial malignancy. The majority of adults with GH deficiency are both physically and psychologically compromised. Body composition is altered with an increased body fat percentage and an increased waist-hip ratio reflecting the predominantly central distribution of the fat. Exercise capacity, muscle strength and bone mineral density are significantly reduced and patients typically report a poor quality of life and lack of energy. In addition they have increased mortality from cardiovascular disease. Licensed indications: Replacement therapy in adults with pronounced growth hormone deficiency Monitoring Ongoing biochemical monitoring of the patient will be undertaken by specialist clinicians every 6-12 months 4. Product information and treatment regimen to be used Dose & Duration of treatment: Initial dose of 0.8iu per day as a single s.c injection increasing based on clinical response & IGF-1 level. Titration of the dose takes 3-4 months which is provided within the clinic. Treatment continues for a further 6 months and is reviewed. Only patients with proven benefit continue treatment with GH. The patient is supervised for the first injection of GH and subsequent treatment is self-administered at home. Preparation Drug Genotropin Somatropin Strength Dosage Somatropin Somatropin Somatropin Somatropin 4 mg (12 ml) vial 5. Regimen Management a) Aspects of care for which the Consultant is responsible GROW 03 fnl Assess the patient & establish the need for Growth Hormone with provision of appropriate information on GHD & it’s treatment Initiation of treatment & titration of dose including review of patient at monthly intervals Clinical & laboratory supervision of patient including assessment of Weight, blood pressure, HbA1c, Lipid profile, IGF-1, IGFBP-3, Fat distribution (waist-hip ratio & bioimpedence), clinical assessment of general health, assessment of quality of life by disease specific questionnaire Adjustment of dosage Hospital will provide supplies of growth hormone until shared care is agreed with GP & injection aids 6-12 monthly review of patient. Shared care should only take place after 9 months of secondary care supply, and the 9 month quality of life assessment. Send letter to GP inviting shared care for the patient Evaluation of any reported adverse event reported by GP or patient b) Aspects of care for which the GP is responsible The GP will notify the consultant if willing to accept shared care Assessment of continued well-being of patient including ADR/ Drug interaction monitoring Prescribing including adjustment of dosage in line with specialist recommendation after three month titration of dose Cessation of therapy or discussion with the named specialist physician in the unlikely event of severe adverse event 6. Summary of cautions, contra indications, side-effects NB: this will not replace the SPC and should be read in conjunction with it. Possible side effects of treatment Adverse event Peripheral oedema Arthralgia Myalgia Hypertension Diabetes mellitus Management Discuss with named specialist physician Discuss with named specialist physician 7. Special considerations No information provided 8. Back-up care available to GP from Hospital, including emergency contact procedures and help line numbers GROW 03 fnl For local decision 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 See attached information 11. Supporting References Acknowledgement: adapted from the shared care protocols produced by NW Growth Hormone panel Reference BNF date and version Reference SPC NICE Guidance TA64 - ‘Human growth hormone (somatropin) in adults with growth hormone deficiency’ August 2003 GROW 03 fnl