Goserelin Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Prostate Cancer

For the palliative treatment of advanced carcinoma of the prostate:
3.6 mg or 10.8 mg subcutaneously into the upper abdominal wall once.
The 3.6 mg dosage may be repeated every 28 days.
The 10.8 mg dosage may be repeated every 12 weeks.

Intended for long-term administration unless clinically inappropriate.

For use in the treatment of Stage B2-C prostate cancer: When administered in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostate cancer, treatment should be started 8 weeks prior to initiating radiotherapy and should continue during radiotherapy.

Usual Adult Dose for Endometriosis

For use in the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy: 3.6 mg subcutaneously into the upper abdominal wall once.
The 3.6 mg dosage may be repeated every 28 days.

The recommended duration of therapy is 6 months.

Usual Adult Dose for Breast Cancer-Palliative

For use in the palliative treatment of advanced breast cancer: 3.6 mg subcutaneously into the upper abdominal wall once.
The 3.6 mg dosage may be repeated every 28 days.

Intended for long-term administration unless clinically inappropriate.

Usual Adult Dose for Bleeding

For use as an endometrial thinning agent prior to endometrial ablation for dysfunctional uterine bleeding: 1 or 2 of the 3.6 mg subcutaneous depot injections (with each depot given four weeks apart). When one depot is administered, surgery should be performed at 4 weeks. When two depots are administered, surgery should be performed within 2 to 4 weeks following administration of the second depot.

Renal Dose Adjustments

No dosing adjustment is necessary in patients with renal impairment.

Liver Dose Adjustments

No dosing adjustment is necessary in patients with hepatic impairment.

Dose Adjustments

Treatment of endometriosis with goserelin should be limited to a period of 6 months.

Goserelin may be used for the treatment of endometrial thinning for a period of 4 to 8 weeks.

For the treatment of anemia caused by uterine fibroids, goserelin may be used with supplemental iron for up to 3 months prior to surgery.

Precautions

The use of goserelin in patients at risk of developing ureteral obstruction or spinal cord compression should be considered carefully and the patient should be monitored closely during the first month of therapy. Patients with ureteral obstruction or spinal cord compression should have appropriate treatment prior to initiation of goserelin.

FDA has identified a potential increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists. Most of the studies reviewed reported small, but statistically significant increased risks of diabetes and/or cardiovascular events. The review is ongoing and no final conclusions on increased risk have been determined. The benefits and risks of GnRH agonists should be carefully weighed when determining treatment choices. Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

For the management of advanced prostate cancer and breast cancer, the drug is intended for long-term administration in the absence of progressive disease. However, continued use of goserelin during progression of prostate cancer may be appropriate to (theoretically) keep the hormone responsive cells from growing during new therapy aimed at hormone refractory cells.

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