Classes
DEA Class; Rx
Common Brand Names; Zoladex, Zoladex LA
- Antineoplastics, GNRH Agonist
Description
A synthetic gonadotropin-releasing hormone (GnRH) agonist
Used for the palliative treatment of advanced prostate cancer or breast cancer, for the management of endometriosis, dysfunctional uterine bleeding, and the adjunct medical management of uterine fibroids
A transient tumor flare may occur during the first few weeks of treatment, which may cause ureteral obstruction and spinal cord compression; monitor patients at risk for these complications
Indications
Indicated for the treatment of breast cancer.
Contraindications
Hypersensitivity to LHRH, LHRH-agonists, any component of product
Pregnancy (for endometriosis), lactation, undiagnosed abnormal vaginal bleeding
Adverse Effects
- Flushing (46-96%)
- Vaginitis (5-75%)
- Hot flashes (62%)
- Reduced libido (47-61%)
- Mood swings (60%)
- Depression (women 54%)
- Sweating (16-45%)
- Acne (42%)
- Diarrhea (40%)
- Breast atrophy (33%)
- Headache (women 32-75%)
- Seborrhea (26%)
- Tumor flare (23%)
- Sexual dysfunction (21%)
- Peripheral edema (21%)
- Erectile dysfunction (18%)
- Pain (8-17%)
- UTI (13%)
- Nausea (9%)
- Lethargy (8%)
- Rash (6%)
- Chronic obstructive pulmonary disease (5%)
- Congestive heart failure(5%)
- Cerebrovascular accident (1-5%)
- Renal impairment (1-5%)
- Headache (men 1-5%)
- Depression (men 1-5%)
- Immune hypersensitivity reaction (>1%)
Warnings
Manifestations of disease may worsen at beginning of therapy
Increase in cervical resistance may occur; caution is recommended when dilating the cervix for endometrial ablation
Avoid pregnancy; premenopausal women should use nonhormonal contraception until >12 wk following end of treatment
Risk of reduced glucose tolerance in men
Males at risk of ureteral obstruction or spinal compression
Risk of pituitary apoplexy (rare)
Ongoing analysis found that men receiving GnRH agonists for prostate cancer were at a small increased risk for diabetes, heart attack, stroke, and sudden death
Do not exceed 1 year treatment duration with GnRH angonists in women except when treating breast cancer
Androgen deprivation therapy may prolong the QT interval; consider risks and benefits
Hypercalcemia has been reported in patients with bone metastases treated with goserelin; monitor and manage appropriately
Increased risk of myocardial infarction, sudden cardiac death and stroke reported in association with use of GnRH analogs in men; monitor for cardiovascular disease and manage according to current clinical practice
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice
Pregnancy must be excluded for use in benign gynecological conditions
Transient worsening of tumor symptoms may occur during first few weeks of therapy, which may include ureteral obstruction and spinal cord compression; monitor patients at risk for complications of tumor flare
Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, reported; use extra care when administering to patients with low BMI and/or to patients receiving full dose anticoagulation
Pregnancy and Lactation
Pregnancy Category: D (advanced breast cancer); X (endometriosis, endometrial thinning)
Lactation: excretion in milk unknown; not recommended
Maximum Dosage
Males: 3.6 mg subcutaneously depot every 28 days or one 10.8 mg depot subcutaneously every 3 months.
Females: 3.6 mg subcutaneously depot every 28 days.
Males: 3.6 mg subcutaneously depot every 28 days or one 10.8 mg depot subcutaneously every 3 months.
Females: 3.6 mg subcutaneously depot every 28 days.
Safety and effectiveness have not been established.
Safety and effectiveness have not been established.
How supplied
Goserelin Acetate
