Zoladex (goserelin acetate)

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to goserelin or any ingredient in the formulation, other gonadotropin-releasing hormone (GnRH) agonists, or GnRH. The implant containing 10.8 mg of goserelin should not be used in women, since there are insufficient data available to date to determine whether this preparation is associated with reliable suppression of serum estradiol. Known or suspected pregnancy unless being used for palliative treatment of advanced breast cancer. Abnormal vaginal bleeding of unknown etiology.

There are no contraindication contraindications for this drug.

• Congenital long QT syndrome
• Depression
• Hypocalcemia
• Hypokalemia
• Hypomagnesemia
• Pregnancy
• Prolonged QT interval

• Acute myocardial infarction
• Bone metastases
• Cerebrovascular accident
• Chronic heart failure
• Diabetes mellitus
• Hypercalcemia
• Hypercholesterolemia
• Hypertension
• Obesity
• Tobacco smoker
• Urinary tract obstruction

Initial (usually during the first weeks of therapy) transient increases in serum testosterone occur in most men receiving goserelin and may be associated with temporary worsening in manifestation of prostate cancer. Similarly, initial increases in serum estrogen concentrations occur in most women receiving goserelin and may be associated with transient worsening in the manifestations of breast cancer. Transient changes in blood pressure (hypotension or hypertension) have occurred in patients receiving goserelin.

Adverse effects occurring in 5% or more of men include hot flushes (flashes), sexual dysfunction, decreased erections, lower urinary tract symptoms, lethargy, pain (worsened in the first month), edema, upper respiratory tract infection, rash, sweating, anorexia, chronic obstructive pulmonary disease, congestive heart failure, dizziness, insomnia, and nausea. Decreases in bone mineral density, osteoporosis, and bone fracture have been reported in men receiving goserelin for prostate cancer. Concurrent use of bisphosphonates may minimize bone mineral loss in men receiving GnRH agonists.

Adverse effects occurring in 5% or more of women include hot flushes (flashes), vaginitis, headache, emotional lability, decreased/increased libido, sweating, depression, acne, breast atrophy, seborrhea, edema (may be peripheral), breast enlargement, pelvic symptoms, pain (e.g., abdominal, breast, back), dyspareunia, infection, asthenia, nausea, hirsutism, insomnia, flu-like syndrome, dizziness, application site reaction, and pharyngitis. Decreases in bone mineral density have occurred in women receiving goserelin; concurrent use of hormone replacement therapy or bisphosphonates (e.g., alendronate) may minimize bone mineral loss associated with GnRH agonist therapy without compromising efficacy of these drugs in the management of endometriosis. (See Cautions: Endocrine Effects andsee Precautions and Contraindications, in Leuprolide Acetate 68:18.08.) Currently available data suggest that recovery of bone loss occurs following cessation of GnRH agonist therapy in most patients.

More Frequent

• Angina
• Diabetes mellitus
• Dyspnea

Less Frequent

• Anemia
• Bone pain
• Cardiac arrhythmia
• Chronic heart failure
• Gout
• Hypercalcemia
• Hypertension
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Osteoporosis
• Peripheral vascular disease
• Pneumonia
• Severe chronic obstructive pulmonary disease
• Skin rash

Rare or Very Rare

• Acute generalized exanthematous pustulosis
• Acute myocardial infarction
• Anaphylaxis
• Cerebrovascular accident
• Deep venous thrombosis
• DRESS syndrome
• Drug-induced psychosis
• Hematuria
• Hemorrhage
• Ovarian cyst
• Ovarian hyperstimulation syndrome
• Pituitary apoplexy
• Pituitary neoplasm
• Psychiatric disorder
• Pulmonary thromboembolism
• Seizure disorder
• Sepsis
• Spinal cord compression
• Stevens-johnson syndrome
• Suicidal
• Suicidal ideation
• Toxic epidermal necrolysis
• Tumor flare reaction
• Urinary tract obstruction
• Urticaria

More Frequent

• Acne vulgaris
• Arthralgia
• Breast size decreased
• Depression
• Drug-induced hot flash
• Erectile dysfunction
• Flu-like symptoms
• Headache disorder
• Hyperglycemia
• Hyperhidrosis
• Injection site sequelae
• Libido changes
• Mood changes
• Peripheral edema
• Seborrhea
• Urinary incontinence
• Urinary retention
• Vaginitis

Less Frequent

• Abdominal distension
• Acute abdominal pain
• Alopecia
• Anorexia
• Breast engorgement
• Constipation
• Cough
• Cramps in legs
• Diarrhea
• Dizziness
• Dry eye
• Dry skin
• Dyspareunia
• Edema
• Fatigue
• Fever
• General weakness
• Gynecomastia
• Herpes simplex infection
• Hypertonia
• Hypotension
• Insomnia
• Lethargy
• Malaise
• Mastalgia
• Myalgia
• Nausea
• Pain
• Palpitations
• Paresthesia
• Pelvic pain
• Pruritus of skin
• Symptoms of anxiety
• Upper respiratory infection
• Urinary tract infection
• Vomiting
• Weight gain

Rare or Very Rare

• Bullous dermatitis
• Ecchymosis
• Erythema multiforme
• Exfoliative dermatitis
• Xerostomia

No enhanced messaging available.

Safety and efficacy not established in children.

Goserelin may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. (See Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)

Goserelin is distributed into milk in animals. Discontinue nursing or drug, taking into account the importance of the drug to the woman.

Clinical studies for use in prostate cancer have been conducted principally in patients 65 years of age and older since prostate cancer occurs mainly in this patient population. The drug has not been studied in female patients older than 65 years of age.