How to take VITRAKVI®

Dosing guidance

  • Take VITRAKVI exactly as your healthcare provider tells you and report any side effects you may experience

  • Your healthcare provider may stop treatment or change your dose of VITRAKVI if you have side effects. Do not change your dose or stop taking VITRAKVI unless your healthcare provider tells you

  • If you have any questions, talk to your healthcare provider or pharmacist

Additional VITRAKVI dosing considerations

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VITRAKVI is usually taken by mouth 2 times a day. Take VITRAKVI with or without food

  • If you vomit after taking a dose of VITRAKVI, wait and take the next dose at your scheduled time

  • If you miss a dose of VITRAKVI, take it as soon as you remember. If your next scheduled dose is due within 6 hours, skip the missed dose and take your next dose at your regular time

VITRAKVI comes in capsules and a liquid formulation

VITRAKVI® (larotrectinib) Capsule Icon

  • The liquid formulation can be given to children under 18 years old or adults

  • Swallow VITRAKVI capsules whole with water. Do not chew or crush the capsules

If your healthcare provider prescribes VITRAKVI liquid formulation

  • Your healthcare provider will provide you with the VITRAKVI liquid formulation, oral syringes, and bottle adaptors or send you to a pharmacy that can provide you with VITRAKVI liquid formulation, oral syringes, and bottle adaptors

  • Your healthcare provider should show you how to correctly measure and give a dose of VITRAKVI liquid formulation

  • See the detailed Instructions for Use that come with VITRAKVI liquid formulation for information about the correct way to measure and give a dose of VITRAKVI liquid formulation

Keep VITRAKVI liquid formulation in the refrigerator. Do not freeze

VITRAKVI® (larotrectinib) Liquid Form Icon

Throw away any unused VITRAKVI liquid formulation

  • after 90 days of first opening a 100 mL bottle and

  • after 31 days of first opening a 50 mL bottle

  • If you take too much VITRAKVI, call your healthcare provider or go to the nearest hospital emergency room right away

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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