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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 1 month 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:

Nervous system problems. Tell your healthcare provider if you develop any symptoms such as confusion, difficulty speaking, dizziness, coordination problems, tingling, numbness, or burning sensation in your hands and feet. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop symptoms of a nervous system problem with VITRAKVI.

Liver problems. Your healthcare provider will do blood tests to check your liver function during treatment with VITRAKVI. 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 last 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.

The most common side effects with VITRAKVI include:

Tiredness

Cough

Nausea

Constipation

Dizziness

Diarrhea

Vomiting

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.