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Kyprolis Warnings and Precautions

If you have problems with your kidneys, liver, or heart, it may not be safe for you to start treatment with Kyprolis. Having certain medical conditions during chemotherapy treatment with this drug may increase your risk for complications, such as heart problems, high blood pressure, and breathing problems. Other precautions for using Kyprolis safely include warnings for women who are pregnant or breastfeeding.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving Kyprolis™ (carfilzomib) if you have:
 
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Heart problems, including congestive heart failure, heart block, or a condition known as long QT syndrome
  • Had a heart attack in the last six months
  • Had a herpes zoster (shingles) infection
  • Dehydration or have difficulty drinking enough fluids throughout the day
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings for Kyprolis

Some warnings and precautions to be aware of prior to using this medication include the following:
 
  • Kyprolis has been reported to cause heart problems, including new or worsening heart failure and heart attacks. In some cases, the heart attacks have led to death. Your healthcare provider will monitor you for heart problems during treatment. People with preexisting heart problems or who have had a heart attack in the six months preceding treatment may have a higher risk for heart complications from Kyprolis.
 
  • This medication may cause a condition known as pulmonary hypertension (high blood pressure in the blood vessels of the lungs). Let your healthcare provider know if you experience symptoms of this condition, such as:
    • Shortness of breath
    • Lightheadedness
    • Swelling of the legs, ankles, or feet.
 
  • Some people have experienced breathing problems during Kyprolis treatment. Although rare, in some cases, the breathing problems caused death. Let your healthcare provider know if you experience shortness of breath or difficulty breathing during treatment.
 
  • Your healthcare provider will give you other medicine before your Kyprolis dose to help prevent a potentially serious allergic-type reaction known as an infusion reaction. Such a reaction can occur while you are receiving your dose, or up to 24 hours later. Let your healthcare provider know immediately if you develop signs of this complication, such as:
    • Fever
    • Chills
    • Muscle or joint pain
    • Sudden warmth and redness of the face (flushing)
    • Swelling of the face
    • Vomiting
    • Weakness
    • Shortness of breath
    • Dizziness
    • Fainting
    • Chest pain or tightness.
 
  • Although rare, there have been reports of a condition known as tumor lysis syndrome occurring in people treated with Kyprolis. Tumor lysis syndrome happens when cancer cells are rapidly destroyed and release their contents into the bloodstream faster than the body can remove them. This can ultimately lead to serious problems, including kidney failure.

    People who have many tumors may have a higher risk for this complication. Your healthcare provider will monitor you for tumor lysis syndrome and treat you for it if necessary.
 
  • Kyprolis causes a decrease in the number of platelets in your blood, which can increase your risk for potentially dangerous bleeding. Platelets are usually at their lowest about eight days after each dose.

    Your healthcare provider will monitor your platelet counts with a blood test frequently throughout treatment. You may need a break in treatment, or a lower Kyprolis dosage, if your platelet counts drop too low. Let your healthcare provider know if you experience any abnormal bleeding or bruising.
 
  • In rare cases, liver failure has occurred in people treated with Kyprolis. Your healthcare provider will monitor your liver function during treatment. You may need to miss doses, or stop treatment altogether, if you begin to have signs of liver problems.
 
  • This medicine may increase blood glucose (blood sugar) levels. If you have diabetes, your healthcare provider may ask you to check your blood sugar levels more often during Kyprolis treatment.
 
  • You may become extremely tired, dizzy, or faint during Kyprolis treatment. Do not drive, operate heavy machinery, or perform any other activity that requires alertness if you experience any of these side effects.
   
  • Kyprolis is a pregnancy Category D medication, which means it may harm an unborn child if used during pregnancy (see Kyprolis and Pregnancy).
 
  • It is unknown whether this medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Kyprolis and Breastfeeding).
 
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