KYPROLIS Takes Flight

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Kyprolis® (carfilzomib) for Injection is a type of medicine called a proteasome inhibitor that works as a single-agent therapy.

KYPROLIS is approved for the treatment of patients with multiple myeloma who have already received at least two other treatments including bortezomib and an immunomodulatory agent (lenalidomide and/or thalidomide), and whose disease has progressed (got worse) on their last therapy or within 60 days of their last therapy. Approval is based on how many patients responded to treatment. Improvement in survival or symptoms has not been proven.

Safety Information

The safety of KYPROLIS was studied in clinical trials of 526 patients with relapsed and/or refractory multiple myeloma.

  • Heart problems: KYPROLIS can cause heart problems or worsen pre-existing heart conditions. Death due to cardiac arrest has occurred within a day of KYPROLIS administration. You will be closely monitored during treatment
  • Pulmonary hypertension (high blood pressure in the lungs): There have been reports of pulmonary hypertension in patients receiving KYPROLIS

INDICATION AND IMPORTANT SAFETY INFORMATION

  • Kyprolis® (carfilzomib) for Injection is approved to treat patients with multiple myeloma who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and whose disease has progressed on or within 60 days of completion of the last therapy. Approval is based on how many patients responded to treatment. Improvement in survival or symptoms has not been proven
  • Before starting treatment with KYPROLIS, tell your doctor if you:
    • Are taking any other medications, including over-the-counter drugs, vitamins, and herbal supplements
    • Are on dialysis. KYPROLIS should be given after the dialysis procedure
    • Are pregnant or plan to become pregnant. Women should not take KYPROLIS while pregnant or breastfeeding and should use effective birth control to prevent pregnancy during treatment
  • KYPROLIS can cause serious side effects, including:
    • Heart problems: KYPROLIS can cause heart problems or worsen pre-existing heart conditions. Death due to cardiac arrest has occurred within a day of KYPROLIS administration. You will be closely monitored during treatment
    • Pulmonary hypertension (high blood pressure in the lungs): There have been reports of pulmonary hypertension in patients receiving KYPROLIS
    • Lung complications: Shortness of breath was reported in 35% of patients receiving KYPROLIS. Your lung function will be closely monitored during treatment
    • Infusion reactions: Symptoms of infusion reactions included fever, chills, joint pain, muscle pain, facial flushing and/or swelling, vomiting, weakness, shortness of breath, low blood pressure, fainting, chest tightness, and chest pain. These symptoms can occur immediately following infusion or up to 24 hours after administration of KYPROLIS
    • Tumor lysis syndrome (TLS): You will be closely monitored during treatment for any signs of TLS
    • Very low platelet count: You will have regular blood tests to check your platelet count during treatment
    • Liver problems: Cases of liver failure, including fatal cases, have been reported in patients receiving KYPROLIS. Your liver function will be closely monitored during treatment
    • Fetal harm: KYPROLIS can cause harm to a fetus when administered to a pregnant woman. Women should avoid becoming pregnant during treatment with KYPROLIS
  • Other serious side effects associated with KYPROLIS include pneumonia, sudden kidney failure, fever, and heart failure
  • The most common side effects seen in patients receiving KYPROLIS include feeling tired (fatigue), low red blood cell count (anemia), nausea, low platelet count (thrombocytopenia), shortness of breath, diarrhea, and fever
  • KYPROLIS may cause tiredness (fatigue), dizziness, fainting, and/or a drop in blood pressure. Do not drive or operate machinery if you experience any of these symptoms
  • You should contact your doctor if you experience any of the following:
    • Fever, chills, shivering, chest pain, cough, or swelling of the feet or legs
    • Shortness of breath
    • Dizziness, light-headedness, or fainting spells
    • Pregnancy (women should not receive KYPROLIS if they are pregnant or breastfeeding)
    • Any other side effect that bothers you or does not go away

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.

Please talk to your doctor and see the full Prescribing Information for additional important safety information.

Important Safety Information

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