Leuprorelin Acetate

Product: Prostap 3 DCS 11.25 mg powder and solvent for prolonged-release suspension for injection in prefilled syringe (leuprorelin acetate, three-month depot), UK SPC https://www.medicines.org.uk/emc/product/4651/smpc. ENDOMETRIOSIS ADD-BACK: 'In women receiving GnRH analogues for the treatment of endometriosis, the addition of hormone replacement therapy (HRT - an estrogen and progestogen) has been shown to reduce bone mineral density loss and vasomotor symptoms. Therefore if appropriate, HRT may be co-administered with PROSTAP 3 taking into account the risks and benefits of each treatment.' OTHER FEMALE INDICATIONS IN THE SAME SPC — note the different route (SUBCUTANEOUS, not intramuscular): advanced breast cancer, 11.25 mg as a single subcutaneous injection every 3 months; early breast cancer, 11.25 mg as a single subcutaneous injection every 3 months in combination with tamoxifen or an aromatase inhibitor, with a recommended adjuvant treatment duration of up to 5 years. In women receiving chemotherapy, leuprorelin should be commenced after completion of chemotherapy once pre-menopausal status has been confirmed. IN COMBINATION WITH AN AROMATASE INHIBITOR: leuprorelin must be initiated at least 6-8 weeks before starting the aromatase inhibitor, with a minimum of one injection given before the AI is commenced; ovarian suppression must be confirmed by low blood concentrations of FSH and estradiol before starting the AI and re-measured every three months during combination therapy; during AI treatment leuprorelin must not be interrupted, to avoid rebound increases in circulating oestrogens in premenopausal women. PROSTAP 3 should not be used for preservation of ovarian function. (The same SPC also covers prostate cancer — 11.25 mg by single subcutaneous injection every three months — which is outside the scope of this page.) CONTRACEPTION: when used 3-monthly at the recommended dose the product usually inhibits ovulation and stops menstruation, but contraception is NOT ensured — patients should use non-hormonal contraception during treatment and after cessation until the return of menses, and should be advised that missing successive doses may cause breakthrough bleeding or ovulation with the potential for conception. ELDERLY: as for adults. PAEDIATRIC: the SPC also carries a central precocious puberty regimen with weight-band dosing every 3 months, to be given under the overall supervision of a paediatric endocrinologist with the dosing scheme adapted individually and bone age monitored at 6-12 month intervals; those paediatric numbers are deliberately not reproduced here (out of scope for this obstetrics and gynaecology page) — verify any paediatric use against a children's formulary and the product SPC. paedDose is null because the SPC states fixed weight-band doses, not a per-kg dose. ADMINISTRATION SAFETY: sterile abscesses at the injection site often occurred when leuprorelin acetate was administered intramuscularly at higher than the recommended dosages; in such cases the product should be administered subcutaneously.