Download SOMATROPIN for growth hormone deficiencies of

Gwent Shared Care Protocol
SOMATROPIN
for growth hormone deficiencies in CHILDREN
Protocol No. 12a
General guidance
PLEASE CHECK http://www.gpmtc.wales.nhs.uk
FOR THE LATEST VERSION OF THIS PROTOCOL
The Gwent Partnership Medicines and Therapeutics Committee has agreed this protocol. It
outlines shared care arrangements for children taking somatropin for the treatment of growth
disorders. This document should be read in conjunction with:
1. The Shared Care Agreement Form
2. The Summary of Product Characteristics (Data Sheet) that relates to the particular
brand of somatropin being prescribed see: http://www.medicines.org.uk/
For use of somatropin in growth hormone deficiencies in adults see Gwent Shared Care
Protocol No. 12b.
1. Licensed
indication
Somatropin is licensed for the treatment of short stature in the following conditions:
a. Growth hormone (GH) deficiency
b. Turner syndrome
c. Prader-Willi syndrome (PWS)
d. Chronic renal insufficiency (CR1) before puberty
e. Born small for gestational age with subsequent growth failure at 4 years of age or
later
f. Short stature homeobox-containing gene (SHOX) deficiency
These indications were approved by NICE (Technology Appraisal No.188, May 2010)
http://www.nice.org.uk/TA188
2. Background
information
GH deficiency remains primarily a clinical diagnosis, supported by auxological information
(measurements of height), biochemical and radiological findings. The diagnosis is usually
confirmed by appropriate GH provocation tests aimed at evaluating the GH reserve of the
children however it is recognised that the definition of a normal response is arbitrary, as there
is a continuous spectrum of GH secretion in childhood. In suspected isolated GH deficiency two
GH provocation tests with an evaluation of other aspects of pituitary function are required
3. Contraindications
 Not for use in seriously ill children (including those with active malignant tumours).
 Children with closed epiphyses.
 Hypersensitivity to the active substance or to any of the excipients.
Special Warnings/Precautions

Somatropin treatment should only be initiated after appropriate assessment by and on the
recommendation of a paediatrician with expertise in managing children with growth
disorders.
4. Dosage regimen
There are currently 6 preparations of somatropin available, in many different presentations. All
products have equivalent efficacy. The choice of agent depends on patient acceptability of the
different presentations and injection devices. The recommended dose varies according to the
condition being treated and should be individually determined for each patient. The dose often
needs to be increased during puberty.
A dose of 25 to 40micrograms/kg daily is recommended in GH deficiency, 45 to
50micrograms/kg daily in Turner syndrome and CR1 and 35 micrograms/kg daily for children
with PWS or who were born SGA.
Somatropin is self-administered at home as a subcutaneous injection each evening. Therapy
should normally be stopped when final height is approached and growth velocity is less than 2
cm total growth in 1 year. The decision to stop treatment should be made by the paediatrician
with special expertise in growth disorders and treatment may need to continue until reevaluation has been undertaken by an adult endocrinologist.
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2006 (Revised Dec.2010 & March 2013)
Approved by: GPMTC
Page 1 of 4
Review Date: July 2011
5. Drug interactions
The growth promoting effects of somatropin may be inhibited by corticosteroid therapy in
doses that exceed those required for replacement therapy.
6. Adverse drug
reactions
Common (1-10%): Transient local pain, discomfort and skin reactions may occur at the injection
site.
Other adverse effects are rare.
Lipoatrophy may occur at site of injection. This can be avoided by varying the site of
administration.
Headache. If severe, recurrent or associated with nausea and vomiting check for papilloedema.
If confirmed consider benign intracranial hypertension, stop treatment and inform Secondary
Care team.
Hypothyroidism has been observed with somatropin. Thyroid function should be monitored.
Insulin resistance, patients who are already diabetic may have increased insulin requirements.
Antibody formation is common but seldom clinically relevant.
Myalgia/Myositis a very rare adverse event that may be related to the preservative m-cresol.
Leukaemia. There is a slight increase in the incidence of acute leukaemia in GH deficient
children. A causal relationship with somatropin treatment has not been established. There is no
evidence to suggest that somatropin increases the incidence of relapse of leukaemia or regrowth of brain tumours.
7. Monitoring
(by Secondary Care)
Regular assessment of growth at 3-6 monthly intervals.
Somatropin treatment should normally be discontinued if there is a poor response to
treatment, defined as an increase in height velocity of less than 50% from baseline, in the first
year of therapy.
Thyroid function to be checked every 1-2 years
Serum IGF-1/IGF-BP3 (GH dependent peptides) to be checked yearly. Somatropin dose to be
adjusted to maintain values within the age-related reference range.
8. Responsibilities
of Specialist Centre
 To confirm patient/carer understanding and consent to treatment.
 To advise the patient/carer on potential side effects (particularly severe or recurrent
headache, visual problems, nausea and/or vomiting) and the action to be taken should they
occur.
 To initiate treatment with somatropin and provide a minimum of one month’s supply.
 To provide training for patient/carer(s) and ensure family are familiar with how to
administer somatropin.
 To send the GP a Shared Care Agreement Form and invite them to participate in the shared
care management of the patient.
 To supply information to GP on brand of somatropin used, dose, frequency and any other
drugs patient is taking.
 To assess and monitor patient’s response to treatment, to adjust somatropin dose and to
perform the on-going monitoring (as above).
 To inform the GP of dosage schedule, monitoring measurements and progress of treatment
after each appointment.
 To inform the GP if the patient fails to attend an appointment and clearly indicate that the
patient is receiving somatropin.
 Stop the treatment when considered to be no longer appropriate.
9. Responsibilities
of patients/carers
 To attend hospital and GP clinic appointments Failure to attend will result in the
medication being stopped.
 To report any adverse events immediately to their specialist or GP.
10. Responsibilities
 To issue ongoing prescriptions for somatropin as per dosage schedule recommended by the
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2006 (Revised Dec.2010 & March 2013)
Approved by: GPMTC
Page 2 of 4
Review Date: July 2011
of Primary Care
specialist and to promote and monitor compliance.
 To inform the specialist services of severe untoward events or side effects and to report
these to the MHRA (using the Yellow Card scheme) as appropriate
11. Specialist centre
contact information
For further advice please contact:
Dr Rebekah Pryce
Consultant paediatrician, RGH 01633 234614
Grace Parfitt
Growth Nurse Specialist, RGH 01633 234525
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2006 (Revised Dec.2010 & March 2013)
Approved by: GPMTC
Page 3 of 4
Review Date: July 2011
Shared Care Agreement Form - CONFIDENTIAL
CONSULTANT REQUEST
To: Dr.
Your patient:
NHS No. (10digit):
was seen on:
with a diagnosis of:
I recommend that the following drug is initiated:
This drug has been accepted as suitable for shared care by the GPMTC. I agree to the responsibilities set out in the
protocol SCP No. 12a (copy attached). This should be read in conjunction with the definition of shared care at
http://www.wales.nhs.uk/sites3/Documents/371/Doc%202%20Defining%20shared%20care.pdf
I am requesting your agreement to sharing the care of this patient. The preliminary tests set out in the protocol have
been carried out. I am currently prescribing the stabilising treatment.
I would like you to undertake treatment from:
The initial treatment will be:
The baseline tests are:
If you undertake treatment I will reassess the patient in ____ weeks. You will be sent a written summary within 14 days.
I will accept referral for reassessment at your request.
The medical staff of the department are available at all times to give you advice.
Consultant Name:
Signature:
Department:
Hospital:
Date:
Contact Telephone Nos:
GP RESPONSE (Please circle the appropriate number below detailing your response)
1. I am willing to undertake shared care as set out in SCP No. _____ for this patient.
2. I would like further information. Please contact me on: _______________________
3. I am unable to undertake shared care for this patient because: (Please state)
_________________________________________________________________________________
G.P. Signature _________________________________________
Date _________
Practice Address/Stamp ________________________________________________
PLEASE RETURN WHOLE COMPLETED FORM OR TO THE REQUESTING CONSULTANT WITHIN 1 WEEK
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2006 (Revised Dec.2010 & March 2013)
Approved by: GPMTC
Page 4 of 4
Review Date: July 2011