Leuprorelin acetate
lDRUG ACTIONAdministration of gonadorelin analogues
produces an initial phase of stimulation; continued
administration is followed by down-regulation of
gonadotrophin-releasing hormone receptors, thereby
reducing the release of gonadotrophins (follicle
stimulating hormone and luteinising hormone) which in
turn leads to inhibition of androgen and oestrogen
production.lINDICATIONS AND DOSE
PROSTAP 3 DCS®
Gonadotrophin-dependent precocious puberty
▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
INJECTION
▶Child: 11. 25 mg every 12 weeks, injections may be
required more frequently in some cases
PROSTAP SR DCS®
Gonadotrophin-dependent precocious puberty
▶BY SUBCUTANEOUS INJECTION, OR BY INTRAMUSCULAR
INJECTION
▶Child: 3. 75 mg every 4 weeks, half this dose is
sometimes used in children with body-weight under
20 kg, injections may be required more frequently in
some caseslUNLICENSED USENot licensed for use in children.
lCONTRA-INDICATIONSUndiagnosed vaginal bleeding
lCAUTIONSPatients with metabolic bone disease (decrease
in bone mineral density can occur)
lSIDE-EFFECTS
▶Common or very commonAcne.emotional lability.
gastrointestinal discomfort.haemorrhage.headache.
metrorrhagia.nausea.vaginal discharge.vomiting
▶Frequency not knownSeizure
lPREGNANCYAvoid—teratogenic inanimalstudies.
lBREAST FEEDINGAvoid.
lMONITORING REQUIREMENTSMonitor bone mineral
density.
lDIRECTIONS FOR ADMINISTRATIONRotate injection site to
prevent atrophy and nodule formation.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder and solvent for suspension for injection
▶Prostap 3 DCS(Takeda UK Ltd)
Leuprorelin acetate 11.25 mgProstap 3 DCS 11. 25 mg powder and
solvent for suspension for injection pre-filled syringes| 1 pre-filled
disposable injectionP£ 225. 72 DT = £ 225. 72
▶Prostap SR DCS(Takeda UK Ltd)
Leuprorelin acetate 3.75 mgProstap SR DCS 3. 75 mg powder and
solvent for suspension for injection pre-filled syringes| 1 pre-filled
disposable injectionP£ 75. 24 DT = £ 75. 24Triptorelin 27-Apr-2017
lDRUG ACTIONAdministration of gonadorelin analogues
produces an initial phase of stimulation; continued
administration is followed by down-regulation of
gonadotrophin-releasing hormone receptors, thereby
reducing the release of gonadotrophins (follicle
stimulating hormone and luteinising hormone) which in
turn leads to inhibition of androgen and oestrogen
production.lINDICATIONS AND DOSE
DECAPEPTYL®SR 11.25MG
Gonadotrophin-dependent precocious puberty
▶BY INTRAMUSCULAR INJECTION
▶Child: 11. 25 mg every 3 months, discontinue when
bone maturation consistent with age of 12 years in girls
or 13 – 14 years in boys
GONAPEPTYL DEPOT®
Gonadotrophin-dependent precocious puberty
▶BY SUBCUTANEOUS INJECTION, OR BY DEEP INTRAMUSCULAR
INJECTION
▶Child (body-weight up to 20 kg):Initially 1. 875 mg every
2 weeks for 3 doses, to be administered on days 0 , 14 ,
and 28 of treatment, then 1. 875 mg every 3 – 4 weeks,
discontinue when bone maturation consistent with age
over 12 years in girls and over 13 years in boys
▶Child (body-weight 20–30 kg):Initially 2. 5 mg every
2 weeks for 3 doses, to be administered on days 0 , 14 ,
and 28 of treatment, then 2. 5 mg every 3 – 4 weeks,
discontinue when bone maturation consistent with age
over 12 years in girls and over 13 years in boys
▶Child (body-weight 31 kg and above):Initially 3. 75 mg
every 2 weeks for 3 doses, to be administered on days 0 ,
14 , and 28 of treatment, then 3. 75 mg every 3 – 4 weeks,
discontinue when bone maturation consistent with age
over 12 years in girls and over 13 years in boyslCONTRA-INDICATIONSUndiagnosed vaginal bleeding
lSIDE-EFFECTS
▶Common or very commonDepression.mood altered
▶UncommonAnaphylactic reaction.haemorrhage.nausea.
vaginal discharge.vomiting
▶Frequency not knownAlopecia.angioedema.
epiphysiolysis.gastrointestinal discomfort.headache.hot
flush.malaise.myalgia.nervousness.pain.skin
reactions.vision disorders.weight increased
lCONCEPTION AND CONTRACEPTIONNon-hormonal, barrier
methods of contraception should be used during entire
treatment period. Pregnancy should be excluded before
treatment, thefirst injection should be given during
menstruation or shortly afterwards or use barrier
contraception for 1 month beforehand.
lPREGNANCYAvoid.
lBREAST FEEDINGAvoid.
lMONITORING REQUIREMENTSMonitor bone mineral
density.
lDIRECTIONS FOR ADMINISTRATIONRotate injection site to
prevent atrophy and nodule formation.
lPRESCRIBING AND DISPENSING INFORMATION
DECAPEPTYL®SR 11.25MGEach vial includes an overage
to allow accurate administration of an 11. 25 mg dose.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder and solvent for suspension for injection
▶Decapeptyl SR(Ipsen Ltd)
Triptorelin 11.25 mgDecapeptyl SR 11. 25 mg powder and solvent for
suspension for injection vials| 1 vialP£ 207. 00 DT = £ 207. 00
▶Gonapeptyl Depot(Ferring Pharmaceuticals Ltd)
Triptorelin (as Triptorelin acetate) 3.75 mgGonapeptyl Depot
3. 75 mg powder and solvent for suspension for injection pre-filled
disposable devices| 1 pre-filled disposable injectionP£ 81. 69472 Gonadotrophin responsive conditions BNFC 2018 – 2019
Endocrine system6