Important Safety Information

ELIGARD®​ is used for the palliative treatment of advanced prostate cancer. ELIGARD is a prescription medication that must be administered by a health care professional.
  • ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any similar drugs.
  • ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., bone pain, urinary symptoms, or nerve problems such as numbness, during this period. If your cancer has spread to the urinary tract or spine, urinary blockage or pressure on the spine that can lead to paralysis may occur. Your doctor will discuss with you the benefits and risks of taking ELIGARD.
  • Increased risk of heart attack, sudden death due to heart problems and stroke have also been reported in men taking ELIGARD. ELIGARD may also affect electrical activity in the heart that can cause an irregular heartbeat. Your doctor will monitor you for heart conditions.
  • Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD. Your doctor will monitor blood sugar levels.
  • Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.
  • ELIGARD may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss.
  • ELIGARD may impair fertility in males of reproductive potential.
The most common injection site reactions are transient burning and stinging, pain, bruising, and redness. The most common side effects include hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, decreased erections and enlargement of breasts. Other side effects, including thinning of bones that may lead to fracture, and rare but serious problems with the pituitary gland in the brain, have been reported with ELIGARD.
These are not all the possible side effects of ELIGARD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see Full Prescribing Informationfor additional Important Safety Information.

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