Treatment of prostate cancer responding to hormonal treatment.
Composition:
1 subcutaneous implant contains 10.8 mg of goserelin (as acetate).
Action:
Goserelin is a synthetic analogue of a naturally occurring hormone - gonadoliberin (LHRH). As a result of long-term administration, goserelin inhibits the secretion of the pituitary luteinizing hormone (LH), which leads to a decrease in blood testosterone in men. Approximately 21 days after the first injection of the subcutaneous implant, the testosterone concentration decreases to the concentration values characteristic of the castration state. The Next dose given every 12 weeks supports this suppression. The drug administered every 12 weeks ensures the maintenance of therapeutic concentration without clinically significant accumulation in the tissues. Goserelin binds to a small extent to plasma proteins. T0,5 in the elimination phase ranges from 2-4 hours in patients with normal renal function; in patients with renal failure is prolonged, however, if administered every 12 weeks, this difference does not affect the accumulation of goserelin.
Contraindications:
Hypersensitivity to goserelin, other LHRH analogues or any of the excipients.
Precautions:
Do not use in women or children. In patients who are at increased risk of ureteral obstruction or vertebral compression with compression of the spinal cord, the drug should be used with caution and during the first month. Patients should be closely monitored. The use of an antiandrogen (eg cyproterone acetate 300 mg daily) should be considered 3 days before goserelin treatment and 3 weeks after the first implant injection - this prevents the occurrence of increased testosterone levels in the initial period of use of LHRH analogues. If there are or symptoms of compression of the spinal cord or renal failure due to ureteral obstruction, standard treatment of these complications should be introduced.
Pregnancy and lactation:
The drug is not indicated for use in women.
Side effects:
The following may occur: joint pain, paresthesia, mild skin rash, hot flushes, increased sweating, reduced potency, transient worsening of bone pain (receding after symptomatic treatment), reduction of bone mineral density. Uncommon: swelling and pain in the breast glands. Rare: hypersensitivity reactions (including anaphylaxis). Occasional: changes in arterial blood pressure (hypotension or hypertension, generally transient, rarely requiring medical intervention or discontinuation of goserelin treatment).
Dosage:
Subcutaneously (in the front wall of the abdomen). Adult men (including the elderly): 1 implant every 12 weeks. No dosage adjustment is necessary for patients with liver or kidney failure.
(C)
