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. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop central nervous system symptoms with VITRAKVI

  • Bone fractures. Bone fractures can happen with VITRAKVI. Tell your healthcare provider if you develop pain, changes in your ability to move around, or bone abnormalities

  • Liver problems. Increased liver enzymes in blood tests are common in people who take VITRAKVI. Increased liver enzymes can sometimes lead to liver problems which can become serious. Your healthcare provider will do blood tests to check your liver function every 2 weeks during the first month of treatment with VITRAKVI, then monthly, as needed. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop liver problems with VITRAKVI

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)

  • 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 the 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. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop central nervous system symptoms with VITRAKVI
  • 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. Increased liver enzymes in blood tests are common in people who take VITRAKVI. Increased liver enzymes can sometimes lead to liver problems which can become serious. Your healthcare provider will do blood tests to check your liver function every 2 weeks during the first month of treatment with VITRAKVI, then monthly, as needed. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop liver problems with VITRAKVI

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. You should not become pregnant during treatment with VITRAKVI
    • 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 at least 1 week after the final 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 at least 1 week after the final 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 final dose of VITRAKVI
  • 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

While on VITRAKVI, you should avoid:

  • driving or operating machinery until you know how VITRAKVI affects you. VITRAKVI can make you feel dizzy
  • 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)
  • cough
  • constipation
  • diarrhea
  • dizziness
  • low levels of calcium in the blood
  • nausea
  • vomiting
  • fever
  • stomach (abdomen) pain

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.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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

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Last updated on 04/2021