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 bone pain, urine outlet blockage, blood in urine, and numbness and/or pain from nerve damage.
- If your cancer has spread to the spine, this may 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, increased risk of diabetes, high lipids (such as cholesterol and triglycerides), and/or the accumulation of liver fat without drinking alcohol can occur in men using LUPRON DEPOT. Your doctor will monitor for these changes.
- 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.
- Treatment with LUPRON DEPOT may cause severe skin reactions that can be life-threatening or fatal. Get medical help right away if you develop any signs or symptoms of a severe skin reaction, including fever or flu-like symptoms; blisters in the mouth, nose, throat, or eyes; severe rash or rash that continues to get worse; sores or blistering or peeling of the skin; or swollen lymph nodes.
- 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.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
US-LUPR-240147
