- KYPROLIS® (carfilzomib) is a prescription medication used to treat 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 dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.
- KYPROLIS® is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one or more previous treatments for multiple myeloma. KYPROLIS is approved for use alone to treat relapsed or refractory multiple myeloma.
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FOR RELAPSED MULTIPLE MYELOMA
FUEL YOUR DETERMINATION
TO LIVE LONGER WITH KYPROLIS®.
If multiple myeloma comes back, let your doctor know that you will do what it takes to live longer.
In two clinical studies with patients with relapsed or refractory multiple myeloma, two KYPROLIS®combinations kept multiple myeloma from getting worse and helped patients live longer.
KYPROLIS® and dexamethasone kept the disease from getting worse longer than Velcade® and dexamethasone (median of 18.7 months compared with 9.4 months) and helped patients live longer (median of 47.6 months compared with 40 months).
KYPROLIS® with Revlimid® and dexamethasone kept the disease from getting worse longer than Revlimid and dexamethasone (median of 26.3 months compared with 17.6 months) and helped patients live longer (median of 48.3 months compared with 40.4 months).
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- 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, 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 or with lenalidomide plus dexamethasone.
- 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. 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.
- 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 avoid becoming pregnant during treatment with KYPROLIS. Men should avoid fathering a child during treatment with KYPROLIS. 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, low white blood cell count, diarrhea, difficulty breathing, tiredness (fatigue), low platelets, fever, sleeplessness (insomnia), muscle spasm, cough, upper airway (respiratory tract) infection, and decreased potassium levels.
- The most common side effects occurring in at least 20% of patients receiving KYPROLIS when used alone (monotherapy) in trials are: low red blood cell count, tiredness (fatigue), low platelets, nausea, fever, difficulty breathing, diarrhea, headache, cough, swelling of the lower legs or hands.
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 USES
- KYPROLIS® (carfilzomib) is a prescription medication used to treat 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 dexamethasone or with lenalidomide plus dexamethasone, which are other medicines used to treat multiple myeloma.
- KYPROLIS® is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one or more previous treatments for multiple myeloma. KYPROLIS is approved for use alone to treat relapsed or refractory multiple myeloma.
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