ZOLADEX
GOSERELIN · by ICI
Composition
Depot Inj: Goserelin (as acetate) 3.6 mg in a bio-degradable depot; single-dose syringe applicator, implant plus applicator.
Indications & Dosage
Locally advanced prostate cancer as an alternative to surgical castration, Adjuvant treatment to radiotherapy or radical prostatectomy, Neoadjuvant treatment prior to radiotherapy in advanced prostate cancer, Metastatic prostate cancer, Advanced breast cancer, Oestrogen-receptor-positive early breast cancer: BY SC INJ: Adult: 3.6 mg every 28 days, to be administered into the anterior abdominal wall. Endometriosis: BY SC INJ: Adult: 3.6 mg every to be administered into the anterior abdominal wall 28 days max. duration of treatment 6 months (do not repeat). Endometrial thinning before intra-uterine surgery: BY SC INJ: Adult: 3.6 mg to be administered into the anterior abdominal wall, dose may be repeated after 28 days if uterus is large or to allow flexible surgical timing. Before surgery in women who have anaemia due to uterine fibroids: BY SC INJ: Adult: 3.6 mg with supplementary iron, to be administered into the anterior abdominal wall, after every 28 days; max. duration of treatment 3 months.
Administration
Insert the hypodermic needle into the subcutaneous fat. Do not try to aspirate with the goserelin syringe. If the needle is in a large vessel, blood will immediately appear in the syringe chamber. Change the direction of the needle so it parallels the ab-dominal wall. Push the needle in until the barrel hub touches the patients skin. Fully depress the plunger to discharge. Withdraw needle and bandage the site. Confirm discharge by ensuring tip of the plunger is visible within the tip of the needle.
Stability
The unit is sterile and comes in a sealed, light and moisture-proof, aluminum foil laminate pouch containing a dessicant capsule. Store at room temperature (do not exceed 25C; 77F).
Contraindications
Undiagnosed vaginal bleeding, use longer than 6 months in endometriosis (do not repeat)
Precautions
Depression, diabetes, hypertension, patients with metabolic bone disease (decrease in bone mineral density can occur),polycystic ovarian disease, risk of spinal cord compression in men, risk of ureteric obstruction in men, patients at risk of osteoporosis. Consider use of antiandrogens to prevent initial flare. Non-hormonal methods of contraception should be used throughout treatment.
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated, avoid
Side Effects
Anaphylaxis, arthralgia, asthma, breast tenderness, changes in blood pressure, changes in breast size, changes in scalp and body hair, decrease in trabecular bone density, depression, dizziness, dyspareunia, GI disturbances, gynaecomastia, headache, heart failure, hot flushes, hypersensitivity reactions, menopausal-like symptoms, migraine, mood changes, musculoskeletal pain and weakness, myalgia, myocardial infarction, oedema of the face and extremities, ovarian cysts (withdraw), palpitation, paraesthesia, pruritus, rash, sexual dysfunction, sleep disorders, urticaria, vaginal bleeding, vaginal dryness, visual disturbances, weight change, withdrawal bleeding