ZOLADEX (goserelin acetate)

There are 0 contraindications.

Drug contraindication overview.

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.

Adverse reaction overview.

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 Effectsandsee 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.

Safety and efficacy not established in children.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None