IMPORTANT SAFETY INFORMATION
KYPROLIS® (carfilzomib) can cause serious side effects:
You should contact your doctor immediately if you experience any of the following:
- 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 will be
closely monitored during treatment.
- Kidney problems: There have been reports of sudden kidney failure in patients receiving KYPROLIS.
Your kidney function will be closely monitored during treatment.
- Tumor lysis syndrome (TLS): Cases of TLS have been reported in patients receiving KYPROLIS, including
fatalities. You will be closely monitored during treatment for any signs of TLS. Interrupt KYPROLIS until
TLS is managed.
- Lung damage: Cases of lung damage have been reported in patients receiving KYPROLIS, including
- 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 will 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 will 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 will assess and may prescribe another medicine to help lower your risk for
- 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
- Very low platelet count: Low platelet levels can cause unusual bruising and bleeding. 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.
- 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 can 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 can
monitor your signs and symptoms.
- 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.
What are the possible side effects of KYPROLIS?
- Fever, chills, shivering, chest pain, cough, or swelling of the feet or legs, bleeding, bruising, weakness,
headaches, confusion, seizures, or loss of sight
- 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
- 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.
Please see accompanying Full Product Information