GnRH analogue Pregnancy: Contraindicated in pregnancy and breast-feeding; exclude pregnancy before starting; foetal malformation has been reported. Usually inhibits ovulation and stops menstruation at the recommended 3-monthly dose, but contraception is not ensured — advise non-hormonal contraception.

Leuprorelin acetate

Brand names: Prostap, Lutrate, Lupron

Leuprorelin acetate is a GnRH (LHRH) agonist given as a depot injection, used in urology mainly for androgen-deprivation therapy in advanced or hormone-sensitive prostate cancer.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 11.25 mg

Route: Subcutaneous injection (three-month depot); intramuscular for endometriosis

Frequency: Every 3 months (administration interval 90 +/- 2 days)

Prostap 3 DCS 11.25 mg three-month depot; must be prepared, reconstituted and administered by healthcare professionals and used immediately; vary the injection site. Prostate cancer: 11.25 mg SC every 3 months; do not discontinue on remission/improvement; usually continued on development of castrate-resistant prostate cancer per guidelines; monitor PSA and serum testosterone (transient testosterone rise/'flare' in the first 4 days, castrate levels by 2-4 weeks). Endometriosis: 11.25 mg IM every 3 months for up to 6 months only; start during the first 5 days of the menstrual cycle; add-back HRT may be co-administered. Advanced breast cancer: 11.25 mg SC every 3 months. Early breast cancer: 11.25 mg SC every 3 months with tamoxifen or an aromatase inhibitor for up to 5 years; when combined with an aromatase inhibitor, start leuprorelin at least 6-8 weeks before the AI and confirm ovarian suppression (low FSH/estradiol). Central precocious puberty (paediatric, under a paediatric endocrinologist; individualised, weight-banded fixed dose, not per-kg): body weight >=20 kg - 11.25 mg (1 ml) SC every 3 months; body weight <20 kg - 5.625 mg (0.5 ml) SC every 3 months; monitor bone age and growth.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to leuprorelin, any excipient, or other synthetic GnRH analogues/derivatives
Women who are or may become pregnant, who are breast-feeding, or who have undiagnosed abnormal vaginal bleeding
Pre-/perimenopausal breast cancer: initiating an aromatase inhibitor before adequate ovarian suppression with leuprorelin is achieved
Girls with central precocious puberty: pregnancy, breast-feeding, undiagnosed vaginal bleeding

Side effects

Hot flushes (very common)
Hyperhidrosis (increased sweating)
Headache (occasionally severe)
Bone pain / muscle weakness; reduced bone mineral density and osteoporosis with long-term use
Nausea; depression and mood changes; initial tumour flare

Clinical monograph

How it works

Sustained GnRH-receptor agonism downregulates pituitary receptors after an initial stimulation, suppressing LH and FSH and reducing testosterone to castrate levels.

Prescribing in practice

An initial testosterone flare can transiently worsen disease, including risk of spinal cord compression or urinary obstruction in metastatic prostate cancer, so co-prescribe an anti-androgen around initiation.
Administer the depot at the scheduled interval by the licensed route (subcutaneous or intramuscular depending on preparation) and rotate sites.
Long-term androgen deprivation carries cardiometabolic and osteoporosis risks that should be assessed and managed.

Monitoring

Monitor testosterone and PSA for treatment response, alongside bone, metabolic and cardiovascular risk during prolonged use.

Counselling the patient

Symptoms may briefly worsen when treatment begins before improving.
Hot flushes, reduced libido and erectile dysfunction are common; report new bone pain or difficulty passing urine.

Evidence & guidelines

Leuprorelin and other GnRH agonists are an established standard for androgen-deprivation therapy in prostate cancer, supported by extensive trial evidence.

Reference: NICE NG131/NG73; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Drugs

Pathways