Golexin

Adults:

Goserelin 3.6 mg: should be administered subcutaneously every 28 days into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician. While a delay of a few days is permissible, every effort should be made to adhere to the 28-day schedule. Stage B2-C Prostatic Carcinoma: When Goserelin is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiation therapy. A treatment regimen using a Goserelin 3.6 mg depot 8 weeks before radiotherapy, followed in 28 days by the Goserelin 10.8 mg depot, can be administered. Alternatively, four injections of 3.6 mg depot can be administered at 28-day intervals, two depots preceding and two during radiotherapy. Prostatic Carcinoma: For the management of advanced prostate cancer, Goserelin is intended for long-term administration unless clinically inappropriate. Endometriosis: For the management of endometriosis, the recommended duration of administration is 6 months. Currently, there are no clinical data on the effect of treatment of benign gynecological conditions with Goserelin for periods in excess of 6 months. Retreatment cannot be recommended for the management of endometriosis since safety data for retreatment are not available. If the symptoms of endometriosis recur after a course of therapy, and further treatment with Goserelin is contemplated, consideration should be given to monitoring bone mineral density. Clinical studies suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to Goserelin is effective in reducing the bone mineral loss which occurs with Goserelin alone without compromising the efficacy of Goserelin in relieving the symptoms of endometriosis. The addition of Hormone Replacement Therapy may also reduce the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism. The optimal drugs, dose and duration of treatment has not been established. Endometrial Thinning: For use as an endometrial-thinning agent prior to endometrial ablation, the dosing recommendation is one or two depots (with each depot given four weeks apart). When one depot is administered, surgery should be performed at four weeks. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot. Breast Cancer: For the management of advanced breast cancer, Goserelin is intended for long-term administration unless clinically inappropriate. Renal or Hepatic Impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment. Goserelin 10.8 mg: should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician. While a delay of a few days is permissible, every effort should be made to adhere to the 12-week schedule. Stage B2-C Prostatic Carcinoma: When Goserelin is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiation therapy. A treatment regimen using one Goserelin 3.6 mg depot, followed in 28 days by one Goserelin 10.8 mg depot, should be administered. Prostatic Carcinoma: For the management of advanced prostate cancer, Goserelin is intended for long-term administration unless clinically inappropriate. Renal or Hepatic Impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment. Women: Goserelin 10.8 mg implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol. For female patients requiring treatment with goserelin, refer to prescribing information for Goserelin 3.6 mg implant.