HOW VITRAKVI® CAN HELP

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204 out of 339 patients had a response to treatment

A responsea means that the cancer reduced in size and/or completely disappeared. Responses were analyzed across 3 clinical trials in 339 adults and children with TRK fusion cancer.

60% Response Rate
24%b (83 patients) had a complete response, which means that their large tumors reduced in size and were able to be removed by surgery or disappeared completely
36% (121 patients) had a partial response, which means that their target tumors reduced in size by 30% or more

How long patients responded to treatment at time of analysis

  • In patients who had their tumors disappear or shrink, responses lasted for a medianc of 43.3 months, with a range of 0.0+ months and 73.7+ monthsd
  • 64% of patients had a response that lasted more than 12 months
  • 45% of patients had a response that lasted more than 24 months
  • The medianc time it took patients to respond to treatment was 2.22 monthse

a A response is a sum of partial response and complete response. Partial response is defined as a reduction in size of target tumors by 30% or more and complete response is defined as complete disappearance of all target tumors.

b 5% were patients who had a partial response and were able to have surgery to be disease free when the study data was analyzed.

c The median is the middle number in a group of numbers.

d The duration of response is how long the response to treatment lasted.

e Range: 0.89 month to 35.84 months.

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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 neurotrophic receptor tyrosine kinase 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.

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

Important Safety Information

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 if they get worse.
  • 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: 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.

    Females who are able to become pregnant:

    • Your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI.
    • You 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:

    • You 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. Taking VITRAKVI with certain other medicines may affect the amount of VITRAKVI or other medicines in your blood and may cause side effects or affect the way that VITRAKVI works.

The most common side effects with VITRAKVI include:

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

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 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.

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 neurotrophic receptor tyrosine kinase 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.

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.

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Last updated on 06/2025