Approved Use

KYPROLIS® (carfilzomib) is a prescription medication used to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS® is approved for use in combination with daratumumab plus dexamethasone, dexamethasone or with lenalidomide plus dexamethasone, or isatuximab plus dexamethasone, which are other medicines used to treat multiple myeloma.
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IMPORTANT SAFETY INFORMATION

KYPROLIS® (carfilzomib) can cause serious side effects:

  • Heart problems: KYPROLIS can cause heart problems or worsen pre-existing heart conditions. Death due to cardiac arrest has occurred within one day of KYPROLIS administration. Before starting KYPROLIS, you should have a full medical work-up (including blood pressure and fluid management). You should be closely monitored during treatment.
  • Kidney problems: There have been reports of sudden kidney failure in patients receiving KYPROLIS. Your kidney function should be closely monitored during treatment.
  • Tumor lysis syndrome (TLS): Cases of TLS have been reported in patients receiving KYPROLIS, including fatalities. You should be closely monitored during treatment for any signs of TLS.
  • Lung damage: Cases of lung damage have been reported in patients receiving KYPROLIS, including fatal cases.
  • 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 patients receiving KYPROLIS. Your lung function should be closely monitored during treatment.
  • High blood pressure: Cases of high blood pressure, including fatal cases, have been reported in patients receiving KYPROLIS. Your blood pressure should be closely monitored during treatment.
  • Blood clots: There have been reports of blood clots in patients receiving KYPROLIS. If you are at high risk for blood clots, your doctor can recommend ways to lower the risk.
  • If you are using KYPROLIS in combination with dexamethasone or with lenalidomide plus dexamethasone or with daratumumab and dexamethasone, your doctor should assess and may prescribe another medicine to help lower your risk for blood clots.
  • If you are using birth control pills or other medical forms of birth control associated with a risk of blood clots, talk to your doctor and consider a different method of birth control during treatment with KYPROLIS in combination with dexamethasone, with lenalidomide plus dexamethasone, or with daratumumab and dexamethasone.
  • Infusion-related reactions: Signs and symptoms of infusion-related reactions included fever, chills, joint pain, muscle pain, facial flushing and/or swelling, swelling of the larynx (voice box), 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. If you experience any of these symptoms, contact your doctor immediately.
  • Severe bleeding problems: Fatal or serious cases of bleeding problems have been reported in patients receiving KYPROLIS. Your doctor should monitor your signs and symptoms of blood loss.
  • Very low platelet count: Low platelet levels can cause unusual bruising and bleeding. You should 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 should be closely monitored during treatment.
  • Blood problems: Cases of a blood disease called thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal cases, have been reported in patients who received KYPROLIS. Your doctor should monitor your signs and symptoms.
  • Brain problems: A nerve disease called Posterior Reversible Encephalopathy Syndrome (PRES), formerly called Reversible Posterior Leukoencephalopathy Syndrome (RPLS), has been reported in patients receiving KYPROLIS. It can cause seizure, headache, lack of energy, confusion, blindness, altered consciousness, and other visual and nerve disturbances, along with high blood pressure. Your doctor should monitor your signs and symptoms.
  • Cases of a brain infection called Progressive Multifocal Leukoencephalopathy (PML), including fatal cases, have been reported in patients receiving KYPROLIS. Your doctor should monitor your signs and symptoms.
  • KYPROLIS should not be combined with melphalan and prednisone: Newly diagnosed transplant ineligible multiple myeloma patients have shown an increased risk of serious and fatal side effects when using KYPROLIS in combination with melphalan and prednisone.
  • Possible fetal harm: KYPROLIS can cause harm to a fetus (unborn baby) when given to a pregnant woman. Women should use effective contraception during treatment with KYPROLIS and for 6 months following the final dose. Men should use effective contraception during treatment with KYPROLIS and for 3 months following the final dose. KYPROLIS can cause harm to a fetus if used during pregnancy or if you or your partner become pregnant during treatment with KYPROLIS.
You should contact your doctor immediately if you experience any of the following:
  • Shortness of breath
  • Prolonged, unusual or excessive bleeding
  • Yellowing of the skin and/or eyes (jaundice)
  • Headaches, confusion, seizures, or loss of sight
  • Pregnancy (women should not receive KYPROLIS if they are pregnant or breastfeeding)
  • Any other side effect that bothers you or does not go away
What are the possible side effects of KYPROLIS?
  • The most common side effects occurring in at least 20% of patients receiving KYPROLIS in the combination therapy trials are: low red blood cell count, diarrhea, high blood pressure (hypertension), tiredness (fatigue), upper airway (respiratory tract) infection, low platelets, fever, cough, difficulty breathing and sleeplessness (insomnia).

These are not all the possible side effects of KYPROLIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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

APPROVED USE

  • KYPROLIS® (carfilzomib) is a prescription medication used to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma. KYPROLIS is approved for use in combination with daratumumab plus dexamethasone, dexamethasone or with lenalidomide plus dexamethasone, or isatuximab plus dexamethasone, which are other medicines used to treat multiple myeloma.