Possible Side Effects

VITRAKVI® may cause serious side effects, including:

  • Central Nervous System (CNS) problems: VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or they get worse.
  • Bone Fractures. Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in ability to move around, or bone abnormalities.

  • Liver problems. Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with VITRAKVI as needed. Tell your healthcare provider right away if you develop new or worsening symptoms of liver problems including:

    • yellowing of skin or the white part of your eyes (jaundice)
    • dark or brown urine
    • pain in the upper right side of your stomach (abdomen)
    • bruising or bleeding more easily than normal
    • tiredness
    • nausea or vomiting
    • loss of appetite

The most common side effects of VITRAKVI include:

  • low red blood cell and white blood cell counts
  • muscle and bone pain
  • tiredness
  • low levels of protein called albumin in the blood
  • increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
  • increase in certain liver blood tests
  • cough
  • constipation
  • diarrhea
  • dizziness
  • low levels of calcium in the blood
  • nausea
  • vomiting
  • fever
  • stomach (abdomen) pain

VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects with VITRAKVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is important to always talk with your healthcare provider about any side effects you have while taking VITRAKVI.

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What is VITRAKVI?

VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

  • are caused by certain abnormal NTRK genes and
  • have spread or if surgery to remove their cancer is likely to cause severe complications, and
  • there is no acceptable treatment option or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

It is not known if VITRAKVI is safe and effective in children younger than 28 days of age.

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

NTRK, neurotrophic receptor tyrosine kinase; TRK, tropomyosin receptor kinase.

Important Safety Information and Indication

VITRAKVI may cause serious side effects, including:

  • Central Nervous System (CNS) problems: VITRAKVI may cause dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep problems. Tell your healthcare provider if you develop any of these symptoms or they get worse.
  • Bone Fractures: Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in ability to move around, or bone abnormalities
  • Liver problems: Abnormal liver blood tests may occur with VITRAKVI and can sometimes become serious. Your healthcare provider will do blood tests to check your liver function before starting and during treatment with VITRAKVI as needed. Tell your healthcare provider right away if you develop new or worsening symptoms of liver problems including:
  • yellowing of skin or the white part of your eyes (jaundice)
  • dark or brown urine
  • pain in the upper right side of your stomach (abdomen)
  • bruising or bleeding more easily than normal
  • tiredness
  • nausea or vomiting
  • loss of appetite

Your healthcare provider may decrease your dose, temporarily stop or permanently stop your treatment with VITRAKVI if you develop serious side effects.

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

  • have liver problems
  • have nervous system (neurological) problems
  • are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with VITRAKVI or think you may be pregnant.
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you
    • Males with female partners who are able to become pregnant should use effective birth control during treatment with VITRAKVI and for 1 week after the last dose of VITRAKVI
  • are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VITRAKVI

While on VITRAKVI, you should avoid:

  • VITRAKVI can make you feel dizzy. Do not drive or operate machinery until you know how VITRAKVI affects you.
  • Avoid taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Certain other medicines may affect how VITRAKVI works and VITRAKVI may affect how other medicines work.

The most common side effects with VITRAKVI include:

  • low red blood cell and white blood cell counts
  • muscle and bone pain
  • tiredness
  • low levels of protein called albumin in the blood
  • increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems)
  • increase in certain liver blood tests
  • cough
  • constipation
  • diarrhea
  • dizziness
  • low levels of calcium in the blood
  • nausea
  • vomiting
  • fever
  • stomach (abdomen) pain

VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects with VITRAKVI. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is VITRAKVI?

VITRAKVI is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:

  • are caused by certain abnormal NTRK genes and
  • have spread or if surgery to remove their cancer is likely to cause severe complications, and
  • there is no acceptable treatment option or the cancer grew or spread on other treatment.

Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.

It is not known if VITRAKVI is safe and effective in children younger than 28 days of age.

VITRAKVI was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of VITRAKVI for this use.

NTRK, neurotrophic receptor tyrosine kinase; TRK, tropomyosin receptor kinase.

For important risk and use information about VITRAKVI, please see the full Prescribing Information.

For Bayer products, you can report these directly to Bayer by clicking here.

© 2023 Bayer. Bayer, the Bayer Cross, and VITRAKVI are registered trademarks of Bayer, and TRAK Assist and VITRAKVI Commitment Program are trademarks of Bayer. All other trademarks are the property of their respective owners.

This site is intended for US audiences only.

 

Last updated on 09/2023