Indication

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

ELIGARD is contraindicated in women, pediatric patients, and patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of ELIGARD. Leuprolide acetate can cause fetal harm if administered to a pregnant woman.

ELIGARD, like other LHRH 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. Isolated 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 LHRH agonists.

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, testicular atrophy, and gynecomastia.

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Important Safety Information

ELIGARD is contraindicated in women, pediatric patients, and patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of ELIGARD. Leuprolide acetate can cause fetal harm if administered to a pregnant woman.

ELIGARD, like other LHRH 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. Isolated 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 LHRH agonists.

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, 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.


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US.LEU.10.05.010 Last Update: May 2010