Important Safety Information about BELEODAQ

  • Low Blood Cell Counts: Patients may experience low blood cell counts. Your doctor will do weekly blood tests to check your blood counts.
    • Low Platelet Count: Lower platelets may cause unusual bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away if this happens.
    • Low Red Blood Cell Count: Lower red blood cell counts may make you feel weak, feel tired, and/or get tired easily. You may appear pale and be short of breath. Contact your doctor if you experience any of these symptoms following treatment with BELEODAQ.
    • Low White Blood Cell Count: Lower white blood cell counts can reduce the body’s defenses against infection. If you have any of the following signs or symptoms of infection (fever, chills, cough, shortness of breath, pain or burning on urination, muscle aches, or worsening skin problems), tell your doctor right away. Serious illness or death could result if such infections are not treated when white blood cell counts are very low.
  • Serious Infections: BELEODAQ may lower the ability of your immune system to fight infections. People receiving BELEODAQ may develop serious infections that can sometimes lead to death. You should not receive BELEODAQ if you have an ongoing active infection. You should tell your doctor if you have any signs or symptoms of an infection.
  • Liver Problems: BELEODAQ may cause liver problems which can lead to death. Your doctor will do blood tests during your treatment with BELEODAQ to check for liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or the white part of your eyes, dark urine, itching, or pain in the right upper stomach area.
  • Tumor Lysis Syndrome (TLS): BELEODAQ can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. As tumor cells die, they break apart and release their contents into the blood causing a change in certain chemicals in the bloodstream, which may cause damage to organs, including the kidneys, heart, and liver. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
  • Nausea, Vomiting, and Diarrhea: Nausea, vomiting, and diarrhea are common with BELEODAQ and can sometimes be serious. Medicines can be given that may help reduce these symptoms. If you experience any of these symptoms, tell your doctor.
  • Pregnancy and Nursing: Tell your doctor if you are pregnant or plan to become pregnant. BELEODAQ can harm your unborn baby. BELEODAQ has not been studied in pregnant women. Tell your doctor if you are breastfeeding or plan to breast-feed. It is not known if BELEODAQ will pass into your breast milk. You and your doctor should decide if you will receive BELEODAQ or breastfeed. You should not do both.
  • Other common side effects may include:
    • – Fatigue
    • – Fever

    These are not all of the potential side effects of BELEODAQ. If you have any side effect that bothers you or that doesn’t go away, be sure to talk with your healthcare professional.

  • Tell your doctor about your medical conditions, including infection, chemotherapy treatment, liver and kidney problems, nausea, vomiting, or diarrhea.
  • Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how BELEODAQ works, and BELEODAQ may affect how other medicines work. Especially tell your doctor if you are also taking medications such as Nexavar (sorafenib), Tarceva (erlotinib), Lopid (gemfibrozil), or ketoconazole. Ask your doctor or pharmacist if you are not sure if your medicine should be avoided while taking BELEODAQ. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.

Please click here to see patient information within the full Prescribing Information for BELEODAQ.

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.

ISI-0154-096100