Formulary
Leuprorelin acetate: Indications, Dosing, Side Effects and Interactions
Administration of gonadorelin analogues produces an initial phase of stimulation; continued administration is followed by down-regulation of...
MedNext Academy | 4 min read
Leuprorelin acetate: Indications, Dosing, Side Effects and Interactions
Administration of gonadorelin analogues produces an initial phase of stimulation; continued administration is followed by down-regulation of...
Drug action
Administration 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.
Indications and dose
**Prostate cancer (specialist use only)**
- **Adult** (By Subcutaneous Injection): 11.25 mg every 3 months.
**Endometriosis (specialist use only)**
- **Adult** (By Subcutaneous Injection, Or By Intramuscular Injection): 3.75 mg every month for maximum duration of 6 months (not to be repeated), to be started during first 5 days of menstrual cycle.
**Pre- and perimenopausal breast cancer (specialist use only)**
- **Adult** (By Subcutaneous Injection): 3.75 mg every month, for further information on use with adjuvant treatments, consult product literature.
**Endometrial thinning before intra-uterine surgery (specialist use only)**
- **Adult** (By Subcutaneous Injection, Or By Intramuscular Injection): 3.75 mg for 1 dose, dose to be given as a single dose between day 3 and 5 of menstrual cycle, 5-6 weeks before surgery.
**Reduction of size of uterine fibroids and of associated bleeding before surgery (specialist use only)**
- **Adult** (By Subcutaneous Injection, Or By Intramuscular Injection): 3.75 mg every month usually for 3-4 months (maximum 6 months).
**Preservation of ovarian function (specialist use only)**
- **Adult** (By Subcutaneous Injection, Or By Intramuscular Injection): Initially 3.75 mg as a single dose 2 weeks before starting chemotherapy, followed by 3.75 mg every month for the duration of chemotherapy treatment.
**Gonadotrophin-dependent precocious puberty (specialist use only) for Prostap 3 DCS**
- **Child (body-weight up to 19 kg)** (By subcutaneous injection): 5.625 mg every 3 months, dose may be increased if necessary. Discontinue when bone maturation consistent with age of 12 years in girls or 13 years in boys.
- **Child (body-weight 20 kg and above)** (By subcutaneous injection): 11.25 mg every 3 months, dose may be increased if necessary. Discontinue when bone maturation consistent with age of 12 years in girls or 13 years in boys.
**Gonadotrophin-dependent precocious puberty (specialist use only) for Prostap PD DCS**
- **Child (body-weight up to 19 kg)** (By subcutaneous injection): 1.88 mg every month, dose may be increased if necessary. Discontinue when bone maturation consistent with age of 12 years in girls or 13 years in boys.
**Gonadotrophin-dependent precocious puberty (specialist use only) for Prostap SR DCS**
- **Child (body-weight up to 19 kg)** (By subcutaneous injection): 1.88 mg every month, dose may be increased if necessary. Discontinue when bone maturation consistent with age of 12 years in girls or 13 years in boys.
- **Child (body-weight 20 kg and above)** (By subcutaneous injection): 3.75 mg every month, dose may be increased if necessary. Discontinue when bone maturation consistent with age of 12 years in girls or 13 years in boys.
Cautions
Diabetes; family history of osteoporosis; patients with metabolic bone disease (decrease in bone mineral density can occur); risk of spinal cord compression in men with prostate cancer; risk of ureteric obstruction in men with prostate cancer
Contraindications
DCS Undiagnosed vaginal bleeding Contra-indications For Prostap SR DCS Undiagnosed vaginal bleeding
Side effects
Common or very common With parenteral use Appetite decreased; arthralgia; bone pain; breast abnormalities; depression; dizziness; fatigue; gynaecomastia; headache; hepatic disorders; hot flush; hyperhidrosis; insomnia; mood altered; muscle weakness; nausea; paraesthesia; peripheral oedema; sexual dysfunction; testicular atrophy; vulvovaginal dryness; weight change Uncommon With parenteral use Alopecia; diarrhoea; fever; myalgia; palpitations; visual impairment; vomiting Rare or very rare With parenteral use Haemorrhage Frequency not known With parenteral use Anaemia; dyslipidaemia; glucose tolerance impaired; hypertension; hypotension; idiopathic intracranial hypertension; insulin resistance; interstitial lung disease; leucopenia; metabolic syndrome; osteoporosis; paralysis; pulmonary embolism; QT interval prolongation; seizure; severe cutaneous adverse reactions (SCARs); skin reactions; spinal fracture; thrombocytopenia; urinary tract obstruction; vulvovaginal infection Side-effects, further information In prostate cancer, during the initial stage (1-2 weeks) increased production of testosterone may be associated with progression of prostate cancer. In susceptible patients this tumour 'flare' may cause spinal cord compression, ureteric obstruction or increased bone pain.
Interactions
**Other interactions (1):**
- Men: Since androgen deprivation treatment may prolong the QT interval, the concomitant use of PROSTAP 3 with medicinal products known to prolong the QT interval or associated with Torsade de pointes...
Pregnancy
Avoid-teratogenic in animal studies.
Breast feeding
Avoid.
Medicinal forms
Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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