Important Safety Information for ELIGARD

Eligard is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists analogs, or any of the components of Eligard. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Eligard is also contraindication in women who are pregnant or may become pregnant. Expected hormonal changes that occur with Eligard treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman.

Eligard, like other GnRH agonists, causes a transient increase in serum testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms during the first weeks of treatment, including bone pain, neuropathy, hematuria, spinal compression, or bladder outlet obstruction. Cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using GnRH agonists.

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. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.

Please see full Prescribing Information and full mixing and administration instructions.