Use1

  • LUPRON DEPOT® (leuprolide acetate for depot suspension) 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 Information1

Use

  • LUPRON DEPOT® (leuprolide acetate for depot suspension) 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

  • LUPRON DEPOT is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs.
  • 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 on 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.
  • 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.
  • 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.
  • 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.
  • Regular blood tests are needed to check your testosterone and prostate-specific antigen (PSA) levels.
  • LUPRON DEPOT may cause fetal harm if administered to a pregnant woman.
  • 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, gastrointestinal, and respiratory problems.

For more information, talk with your healthcare provider.

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.

US-LUPR-190306

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch call 1-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org for assistance.

Please see accompanying Full Prescribing information.