Goserelin

What it is and how it works

Mechanism of Action ZOLADEX is a synthetic decapeptide analogue of GnRH. ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation. In animal and in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor.

Indications

is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate Palliative treatment of advanced carcinoma of the prostate The management of endometriosis Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women Stage B2-C Prostatic Carcinoma ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy . Prostatic Carcinoma ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate . Endometriosis ZOLADEX is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy.

Dosage and administration (summary)

ZOLADEX, at a dose of 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. ZOLADEX 3.6 mg should be administered subcutaneously every 28 days ( 2.1 , 2.7 ) For the management of endometriosis, the recommended duration of administration is 6 months for women 18 years of age and older Stage B2-C Prostatic Carcinoma When ZOLADEX is given in combination with radiotherapy and flutamide for patients with Stage T2b-T4 (Stage B2-C) prostatic carcinoma, treatment should b…

Contraindications

Hypersensitivity Pregnancy unless used for treatment of advanced breast cancer Hypersensitivity Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in those patients who have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX . Pregnancy ZOLADEX is contraindicated during pregnancy unless ZOLADEX is being used for palliative treatment of advanced breast cancer.

Warnings and precautions

Women of Childbearing Potential and Pregnancy: Pregnancy must be excluded for use in benign gynecological conditions. Women should avoid pregnancy Tumor Flare Phenomenon: Transient worsening of tumor symptoms may occur during the first few weeks of treatment with ZOLADEX, which may include ureteral obstruction and spinal cord compression. Monitor patients at risk for complications of tumor flare ( 5.2 , 6.2 ) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs.

Pregnancy

Pregnancy ZOLADEX is contraindicated during pregnancy unless ZOLADEX is being used for palliative treatment of advanced breast cancer. There are no adequate and well-controlled studies in pregnant women using ZOLADEX.

Storage and supply

is supplied as a sterile and totally biodegradable D,L-lactic and glycolic acids copolymer impregnated with 3.8 mg goserelin acetate, equivalent to 3.6 mg of goserelin, in a disposable syringe device fitted with a 16-gauge x 36 +/- 0.5 mm siliconized hypodermic needle with protective needle sleeve [SafeSystem ® Syringe] (NDC 70720-950-36).

Source: Goserelin (Zoladex) — US FDA prescribing information, 2026-03-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.