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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
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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
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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

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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
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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
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