HOW TO TAKE VITRAKVI®

  • Take VITRAKVI exactly as your healthcare provider tells you
  • 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
  • Your healthcare provider will provide you with the VITRAKVI oral solution and oral syringes or send you to a pharmacy that can provide you with VITRAKVI oral solution and oral syringes
  • Your healthcare provider should show you how to correctly measure and give a dose of VITRAKVI oral solution
  • See the detailed Instructions for Use that comes with VITRAKVI oral solution for information about the correct way to measure and give a dose of VITRAKVI oral solution. If you have any questions, talk to your healthcare provider or pharmacist

VITRAKVI comes in capsules and an oral solution
  • The oral solution can be given to children under 18 years old or adults
  • Swallow VITRAKVI capsules whole. Do not chew or crush the capsule
  • VITRAKVI is usually taken by mouth 2 times a day
  • If you miss a dose of VITRAKVI, take it as soon as you remember, unless your next scheduled dose is due within 6 hours. Take the next dose at your regular time
  • If you vomit after taking a dose of VITRAKVI, wait and take the next dose at your scheduled time
Take VITRAKVI with or without food
If you take too much VITRAKVI, call your healthcare provider or go to the nearest hospital emergency room right away

Keep VITRAKVI and all medicines out of the reach of children and pets.




Tips to help you stay on track with your treatment

It is important to take VITRAKVI exactly as your healthcare provider tells you. Here are a few tips that may help you stay on track with your treatment:


Keep VITRAKVI capsules in a place where you will see them and remember to take them (for instance, next to your bed)
  • Use a pillbox to keep track of each day’s doses
  • Capsules should be stored at room temperature between 68°F and 77°F
Set a reminder on your phone or download a reminder app to alert you when it’s time to take VITRAKVI
Keep a small calendar or notepad near your medicine bottle so you can check off each time you take it
If you use the oral solution of VITRAKVI, keep it in the refrigerator between 36°F and 46°F. Do not freeze
  • Use a refrigerator magnet or calendar to help remember when to take VITRAKVI
  • Throw away (dispose of) any unused VITRAKVI oral solution remaining after 90 days of first opening the bottle

Talk with your healthcare provider if you are having trouble taking your medicine as prescribed. He or she may be able to help.


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 is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in other clinical trials.

Important Safety Information

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 starting 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:

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.

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.

NTRK, neurotrophic receptor tyrosine kinase.

Attention

You are now leaving the VITRAKVI.com website.
Bayer is not responsible for the content presented by any independent website, including any advertising claims, special offers, illustrations, names, or endorsements.

Thank you for visiting VITRAKVI.com.

Attention

The information provided in this section is intended
expressly for healthcare professionals in the United States.
Click 'OK' to enter if you are a US healthcare professional

Attention

You are now leaving the VITRAKVI.com website.
Bayer is not responsible for the content presented by any independent website, including any advertising claims, special offers, illustrations, names, or endorsements.

Thank you for visiting VITRAKVI.com.

Attention

You are now leaving the VITRAKVI.com website.
Bayer is not responsible for the content presented by any independent website, including any advertising claims, special offers, illustrations, names, or endorsements.

Thank you for visiting VITRAKVI.com.

Attention

You are now leaving the VITRAKVI.com website.
Bayer is not responsible for the content presented by any independent website, including any advertising claims, special offers, illustrations, names, or endorsements.

Thank you for visiting VITRAKVI.com.