LUCRIN
LEUPRORELIN ACETATE · by ABBOTT
Composition
Inj3.75 mg/5 mg/7.5 mg/11.25 mg/22.5 mg: Le-uprorelin acetate 3.75 mg/5 mg/7.5 mg/11.25 mg/22.5 mg; powder in microcapsule depot in vial plus 1 ml diluent.
Indications & Dosage
Advanced prostate cancer as an alternative to surgical castration, Adjuvant treatment to radiotherapy or radical prostatectomy in advanced prostate cancer, Metastatic prostate cancer: BY SC INJ: Adult: 11.25 mg every 3 months. BY SC OR IM INJ: Adult: 3.75 mg every month. Endometriosis: BY IM INJ: Adult: Initially 11.25 mg for 1 dose as a single dose in first 5 days of menstrual cycle, then11.25 mg every 3 months for max. 6 months(course not to be repeated). BY SC OR IM INJ: Adult: Initially 3.75 mg for 1 dose as a single dose in first 5 days of menstrual cycle, then3.75 mg every month for max. 6 months (course not to be repeated). Endometrial thinning before intra-uterine surgery: BY SC OR IM INJ: Adult: Initially 3.75 mg for 1 dose 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: BY SC OR IM INJ: Adult: Initially 3.75 mg every month usually for 3-4 months (max. 6 months).
Administration
Single-use kit: For a single IM injection. Prefilled dual-chamber syringe: Remove the needle guard and advance the plunger to expel air from the sy-ringe. Inject the entire contents of the syringe IM (Lupron) or SC (Eligard) as for a normal injection. Injection: Vary the injection site periodically. Use the syringes provided in the kit, if alternate syringes are needed, use insulin syringes. Depot-Ped: Must be administered under physician supervision as a single IM injection. Injection: May be administered by a patient/parent or healthcare provider as a single SC injection.
Stability
Injection: Store below room temperature (25C). Avoid freezing. Protect from light. Store vial in carton until use. Depot: Store at 25C, excursions is permitted to 15C-30C. The product does not contain a preservative; therefore discard if not used immediately.
Contraindications
Undiagnosed vaginal bleeding.
Precautions
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. Use barrier contraceptive. Caution with chronic use of other drugs which reduce bone density including alcohol and tobacco. To-reduce risk of flare on initial therapy, an anti-androgen may be administered 3 days before therapy and continued for 2-3 weeks. Patients at risk of ureteric obstruction and spinal cord compression; monitor in first few weeks and consider anti-androgens. In treatment of uterine fibroids, confirm diagnosis and exclude an ovarian mass before starting therapy. Warn patients of possibility of abnormal bleeding or pain due to acute degeneration of submucous fibroids. Exclude pregnancy before starting therapy.
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated, avoid
Side Effects
Altered glucose tolerance and blood lipids, anaphylaxis, anorexia, asthma, breast tenderness (males and females), changes in blood pressure, breast size and scalp and body hair, chills, decrease in trabecular bone density, depression, diarrhoea, dizziness, dyspareunia, fatigue, fever, GI disturbances, headache, hot flushes, hypersensitivity reactions, jaundice, leucopenia, local reactions at injection site, loss of libido, menopausal-like symptoms, migraine, mood changes, musculoskeletal pain and weakness, nausea, palpitation, paraesthesia, paralysis, pruritus, pulmonary embolism, rash, sexual dysfunction, sleep disturbances, spinal fracture, thrombocytopenia, urticaria, vaginal bleeding, vaginal dryness, visual disturbances, vomiting, weight changes