INDICATIONS

FULL PRESCRIBING INFORMATION

PATIENT INFORMATION

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IMPORTANT SAFETY INFORMATION

KRAZATI may cause serious side effects, including stomach and intestinal (gastrointestinal) problems, changes in the electrical activity of the heart called QTc prolongation, liver problems, and lung or breathing problems.

Before taking KRAZATI, tell your healthcare provider about all of your medical conditions, including if you:

 
  • have any heart problems, including heart failure and congenital long QT syndrome
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if KRAZATI can harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if KRAZATI passes into your breastmilk. Do not breastfeed during treatment and for 1 week after your last dose of KRAZATI

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KRAZATI can affect the way other medicines work, and other medicines can affect how KRAZATI works.

KRAZATI can cause serious side effects, including:

 
  • Stomach and intestinal (gastrointestinal) problems. Stomach and intestinal side effects including nausea, diarrhea, or vomiting, are common with KRAZATI but can also sometimes be severe. KRAZATI can also cause serious stomach and intestinal side effects such as bleeding, obstruction, inflammation of the colon (colitis), and narrowing (stenosis)

    • Call your healthcare provider if you develop any of the signs or symptoms of stomach or intestinal problems listed above during treatment with KRAZATI

    • Your healthcare provider may prescribe an antidiarrheal medicine or anti-nausea medicine, or other treatment, as needed
       
  • Changes in the electrical activity of your heart called QTc prolongation. Certain changes can occur in the electrical activity of your heart during treatment with KRAZATI, and can be seen on a test called an electrocardiogram (ECG or EKG). QTc prolongation can increase your risk for irregular heartbeats that can be life-threatening, such as torsades de pointes, and can lead to sudden death

    • You should not take KRAZATI if you have congenital long QT syndrome or if you currently have QTc prolongation. See “Before taking KRAZATI, tell your healthcare provider about all of your medical conditions, including if you:”

      • Your healthcare provider should monitor the electrical activity of your heart and the levels of body salts in your blood (electrolytes) especially potassium and magnesium before starting and during treatment with KRAZATI if you have heart failure, a slow heart rate, abnormal levels of electrolytes in your blood, or if you take a medicine that can prolong the QT interval of your heartbeat

      • Tell your healthcare provider if you feel dizzy, lightheaded, or faint, or if you get abnormal heartbeats during treatment with KRAZATI
  • Liver problems. Abnormal liver blood test results are common with KRAZATI and can sometimes be severe. Your healthcare provider should do blood tests before starting and during treatment with KRAZATI to check your liver function. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including:

    • your skin or white part of your eyes turns yellow (jaundice), dark or “tea-colored” urine, light-colored stools (bowel movements), tiredness or weakness, nausea or vomiting, bleeding or bruising, loss of appetite, pain, aching, or tenderness on the right side of your stomach area (abdomen)
       
  • Lung or breathing problems. KRAZATI may cause inflammation of the lungs that can lead to death. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough, or fever

The most common side effects

 
  • The most common side effects of KRAZATI when used alone for NSCLC include: nausea, diarrhea, vomiting, tiredness, muscle and bone pain, kidney problems, swelling, decreased appetite, trouble breathing

  • The most common side effects when KRAZATI is used in combination with cetuximab for CRC include: skin rash, nausea, diarrhea, vomiting, tiredness, muscle and bone pain, headache, dry skin, stomach pain, decreased appetite, swelling, low red blood cell count, cough, dizziness, constipation, nerve damage in the arms and legs

Certain abnormal blood test results are common during treatment with KRAZATI, when used alone or in combination with cetuximab. Your healthcare provider will monitor you for abnormal blood tests and treat you if needed.

KRAZATI may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of KRAZATI. Call your doctor for medical advice about side effects. You may report side effects to the FDA. Visit  fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to 1-844-647-2841.

Please see KRAZATI Patient Information. 

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