Download TRIPTORELIN (Gonapeptyl Depot® or Decapeptyl

Gwent Shared Care Protocol
TRIPTORELIN
for confirmed central precocious puberty
Protocol No. 21
General guidance
PLEASE CHECK http://www.gpmtc.wales.nhs.uk
FOR THE LATEST VERSION OF THIS PROTOCOL
The ABHB Medicines and Therapeutics Committee has endorsed this protocol. It outlines
shared care arrangements for both triptorelin preparations licensed for the treatment of
central precocious puberty:
 3.75mg prefilled syringe (Gonapeptyl Depot®) – administered every 4 weeks
 11.25mg vial (Decapeptyl SR®) – administered every 3 months
This document should be read in conjunction with:
1. The Shared Care Agreement Form (attached below)
2. The appropriate Summary of Product Characteristics (see links in section 16 below)
1. Licensed indication
Treatment of confirmed central precocious puberty (girls under 9 years, boys under 10 years).
2. Therapeutic use &
Background
information
Central precocious puberty (CPP) is characterized by early pubertal changes, acceleration of
growth velocity, and rapid bone maturation that often result in reduced adult height. An onset
of pubertal signs before the age of 8 years in girls (or menarche before age 9 years) and before
9 years in boys should always be evaluated. A combination of clinical signs, bone age, pelvic
echography in girls, and hormonal data are required to diagnose CPP and make a judgment
concerning progression and prognosis. The estimated incidence is 1 in 5,000 to 10,000.
Not all children with apparently true CPP require medical intervention. The main reasons for
treatment are to prevent compromised adult height and to avoid psychosocial or behavioural
problems.
Triptorelin is a synthetic decapeptide analogue of the natural gonadotrophin-releasing
hormone (GnRH). GnRH is synthesised in the hypothalamus and regulates the biosynthesis and
release of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone)
by the pituitary. Triptorelin stimulates the pituitary more strongly to secretion of LH and FSH
than a comparable dose of gonadorelin, whereas the duration of action is longer.
The increase of LH and FSH levels will initially lead to an increase of serum testosterone
concentrations in boys or serum oestrogen concentrations in girls. Chronic administration of a
GnRH agonist results in an inhibition of pituitary LH- and FSH-secretion.
3. Contraindications
 Known hypersensitivity to triptorelin, poly-(d,l lactide coglycolide), dextran, or to any of
the excipients
 Progressive brain tumours
Special Warnings/Precautions
1. The chronological age at the beginning of therapy should be under 9 years in girls and
under 10 years in boys.
2. After finalising the therapy, development of puberty characteristics will occur. Information
with regards to future fertility is still limited but at present no evidence suggests this is
compromised. In most girls menses will start on average one year after ending the therapy,
which in most cases is regular.
3. Pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropinindependent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia)
should be precluded.
4. Allergic and anaphylactic reactions have been reported in children (with a higher reporting
rate than in adults). These include both local site reactions and systemic symptoms.
4. Typical Dosage
regimens
Notes on administration:
1. injection site should be rotated to prevent atrophy and nodule formation.
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2011 (Revised March 2013)
Approved by: ABHB MTC
Page 1 of 4
Review Date: March 2015
2. following reconstitution of the dry triptorelin powder it should be used immediately.
Decapeptyl SR: by intramuscular injection
Body-weight > 30kg
11.25mg every 3 months
Note Each vial includes an overage to allow accurate
administration of 11.25mg dose
Gonapeptyl: by subcutaneous OR by intramuscular injection
Body-weight < 20kg
initially 1.875mg on days 0, 14, and 28, then 1.875mg every 4
weeks
Body-weight 20 to 30kg
initially 2.5mg on days 0, 14, and 28, then 2.5mg every 4
weeks
Body-weight > 30kg
initially 3.75mg on days 0, 14, and 28, then 3.75mg every 4
weeks; discontinue when bone maturation consistent with
age over 12 years in girls and over 13 years in boys
Note may be given every 3 weeks if necessary.
5. Drug interactions
6. Adverse drug
reactions
Drugs which raise prolactin levels (e.g. antipsychotics) reduce the level of GnRH receptors in
the pituitary and should not be prescribed concomitantly.
Oestrogen-containing medicines should not be used during treatment with triptorelin.
Clinical condition specific to children with
reported frequency
Common (≥1/100 to <1/10):
Injection site reactions (pain
erythema) with i.m.
administration
Management
Contact specialist
Uncommon ( > 1/1000, < 1/100):
Vaginal bleeding and discharge
Expected only on initiation of triptorelin (warn family)
Nausea and vomiting
Contact specialist
Anaphylaxis
Follow APLS management. Contact specialist
7. Baseline
investigations (by
specialist centre)
To be performed by specialist centre
1. height, weight and pubertal staging
2. LH/FSH
3. oestradiol/testosterone
4. Bone age
5. Pelvic ultrasound (girls)
6. Consider MRI scan of head (inc. pituitary and hypothalamus)
8. Ongoing
monitoring (by
specialist centre)
Every 3 to 6 months: Growth and response to treatment – height and weight measurements as
well as pubertal staging.
Every 12 months: Bone age assessment.
As indicated: hormone measurements.
9. Pharmaceutical
aspects
10. Specialist centre
contact information
Only Gonapeptyl Depot 3.75mg should be stored in a refrigerator.
11. Criteria for Shared
Care
Prescribing responsibility will only be transferred when:
 Treatment is for a specified indication.
 Treatment has been initiated and established by the Specialist Centre.
 The patient’s initial reaction to and progress on the drug is satisfactory.
 The patient’s general physical, mental and social circumstances are such that he/she would
For further advice please contact:
Dr Rebekah Pryce
Consultant Paediatrician
Dr Christopher Bidder Consultant Paediatrician
Royal Gwent Hospital 01633 234614
Nevill Hall Hospital 01873 234525
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2011 (Revised March 2013)
Approved by: ABHB MTC
Page 2 of 4
Review Date: March 2015
benefit from shared care arrangements.
12. Responsibilities of
initiating specialist
 To confirm patient/carer understanding and consent to treatment.
 To advise the patient/carer on potential side effects and the action to be taken should they
occur.
 To initiate treatment with triptorelin and to administer the first two injections.
 To send the GP a Shared Care Agreement Form (Page 5 below) and invite them to
participate in the shared care management of the patient.
 To supply information to GP on particular triptorelin preparation used (including dose and
frequency) and any other drugs patient is taking.
 To assess and monitor patient’s response to treatment as above (section 8) and to make
any dose adjustments.
 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 triptorelin.
 To stop the triptorelin when considered to be no longer appropriate.
13. Responsibilities of
Primary Care
 To return the Shared Care Agreement Form (below) to the requesting consultant within
one week of receipt.
 To issue ongoing prescriptions for triptorelin as per dosage schedule recommended by the
specialist.
 To administer triptorelin.
 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
14. 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.
15. Responsibilities of
all prescribers
Any suspected serious adverse reaction to an established drug should be reported to MHRA
via the “yellow card scheme.” http://yellowcard.mhra.gov.uk/
16. Supporting
documentation/infor
mation
BNF for Children Section 6.4.2 Anti-androgens and precocious puberty
Summary of Product Characteristics:
Decapeptyl SR:
http://www.medicines.org.uk/EMC/medicine/13851/SPC/Decapeptyl+SR+11.25mg
Gonapeptyl Depot®:
http://www.medicines.org.uk/EMC/medicine/12870/SPC/Gonapeptyl+Depot+3.75+m
g/
Patient Information leaflets:
Decapeptyl SR:
http://www.medicines.org.uk/EMC/medicine/13849/PIL/Decapeptyl+SR+11.25mg/
Gonapeptyl Depot®:
http://www.medicines.org.uk/EMC/medicine/17988/PIL/Gonapeptyl+Depot+3.75mg/
Consensus statement on the use of GnRH analogs in children.
The European Society for Pediatric Endocrinology (ESPE) and the Lawson Wilkins Pediatric
Endocrine Society (LWPES)
Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone
analogs in children. Pediatrics. 2009 Apr;123(4):e752-762.
Other information
Shared care arrangements for triptorelin in CPP are also available to GPs in
1. Cardiff & Vale and Cwm Taf Health Board areas:
http://www.wmic.wales.nhs.uk/shared_care.php
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: July 2011 (Revised March 2013)
Approved by: ABHB MTC
Page 3 of 4
Review Date: March 2015
Shared Care Agreement Form - CONFIDENTIAL
CONSULTANT REQUEST
To: Dr.
Your patient:
NHS No. (10 digit):
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 ABHBMTC. I agree to the responsibilities set out in the
protocol SCP No. (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 2011 (Revised March 2013)
Approved by: ABHB MTC
Page 4 of 4
Review Date: March 2015