Use and Important Safety Information you should know about Lupron Depot® (leuprolide acetate for depot suspension)

Use for LUPRON DEPOT® (leuprolide acetate for depot suspension)

  • LUPRON DEPOT 7.5 mg for 1−month, 22.5 mg for 3−month, 30 mg for 4−month, and 45 mg for 6−month administration are prescribed for the palliative treatment of advanced prostate cancer.
  • LUPRON DEPOT is a prescription medication that must be administered in your doctor’s office.

Important Safety Information for LUPRON DEPOT

  • LUPRON DEPOT is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs.
  • LUPRON DEPOT is not for women who are or may become pregnant.
  • LUPRON DEPOT causes an increase in testosterone during the first few weeks of therapy.
    • Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain.
    • If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be life threatening.
    • You may require close medical attention during the first few weeks of therapy. Notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.
  • Regular blood tests are needed to check your testosterone and PSA levels.
  • High blood sugar and increased risk of diabetes can occur in men using LUPRON DEPOT. Your doctor will monitor your blood sugar during treatment.
  • Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting treatment and report any new symptoms during treatment.
  • Long-term use of LUPRON DEPOT can affect the electrical activity of your heart. Your doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially if you have congenital long QT syndrome, abnormal blood tests for electrolytes, congestive heart failure, or if you take medications to regulate your heartbeat.
  • LUPRON DEPOT may cause impotence.
  • The most common side effects of LUPRON DEPOT include: hot flashes/sweats, injection site reaction/pain, general pain, swelling, testicular shrinkage, difficulty urinating, fatigue/weakness, headache, and joint, GI, and respiratory problems.

For more information, talk with your health care provider.

Reference: LUPRON DEPOT [package insert]. North Chicago, IL: Abbott Laboratories.

Please see the full Prescribing Information for Lupron Depot.

Lupron Depot is available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).
If you cannot afford your medication, contact www.pparx.org or call the
toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

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