Adult Dosing
Stage T2b-T4 (Stage B2-C) carcinoma of the prostate (given in combination with radiotherapy and flutamide)
- Start 3.6 mg depot 8 wks before radiotherapy, followed in 28 days by the 10.8 mg depot SC x1. Alt: 4 injections of 3.6 mg depot can be administered at 28-day intervals, 2 depots preceding and 2 during radiotherapy
Advanced prostate carcinoma
- 3.6 mg SC q28 days or alternatively 10.8 mg SC q12 wks; intended for long-term administration unless clinically inappropriate
Endometriosis
- 3.6 mg SC q28 days x 6 months
Endometrial thinning
- 3.6 mg SC q28 days x 1-2 depots (each depot given 4 wks apart). When 1 depot is administered, surgery is performed at 4 wks; if 2 depots are administered, surgery is performed within 24 wks after administration of the 2nd depot
Advanced breast cancer
- 3.6 mg SC q28 days, intended for long-term administration unless clinically inappropriate
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Prior to initiation of therapy, pregnancy must be excluded for use in benign gynecological conditions; women of childbearing potential should be advised to avoid becoming pregnant
- Patients should be apprised of the potential hazard to the fetus with the use of drug during pregnancy for the palliative treatment of advanced breast cancer
- Transient worsening of tumor symptoms (prostate or breast cancer) may occur during the first few weeks of treatment, which may include ureteral obstruction and spinal cord compression in patients with prostate cancer. Monitor patients at risk for complications of tumor flare
- Patients receiving GnRH agonists reported an increased risk of developing diabetes (hyperglycemia) in men. Monitor blood glucose levels and/or glycosylated hemoglobin (HbA1c) periodically and manage with current clinical practice
- Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with the use of GnRH agonists in men. Monitor for signs and symptoms suggestive of cardiovascular disease and manage according to current clinical practice
- Hypercalcemia has been reported in prostate and breast cancer patients with bone metastases treated with goserelin; monitor and manage appropriately
- Hypersensitivity, antibody formation, and acute anaphylactic reactions have occurred in patients receiving goserelin
- Increase in cervical resistance may occur during therapy. Caution is recommended when dilating the cervix for endometrial ablation
Cautions: Use cautiously in
Pregnancy Category:D (advanced breast cancer), X (endometriosis and endometrial thinning)
Breastfeeding: Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.