WARNINGS
Before taking VITRAKVI, tell your healthcare provider about all of your medical conditions,
including if you:
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:
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:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
USES
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.
HOW TO USE
Take VITRAKVI exactly as your healthcare provider tells you.
Do not change your dose or stop taking VITRAKVI unless your healthcare provider tells you.
VITRAKVI comes in capsules and as an oral solution.
If your healthcare provider prescribes VITRAKVI oral solution:
Your healthcare provider will provide you with the VITRAKVI oral solution, oral syringes and bottle adaptors or send you to a pharmacy that can provide you with VITRAKVI oral solution, oral syringes and bottle adaptors.
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 is usually taken by mouth 2 times a day.
Swallow VITRAKVI capsules whole with water. Do not chew or crush the capsules.
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 regularly scheduled time.
If you take too much VITRAKVI, call your healthcare provider or go to the nearest hospital emergency room right away.
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 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 your skin or the white part of
your eyes (jaundice)
dark or brown urine
pain in the upper right side of your
stomach area (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.
The most common side effects of 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 doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of VITRAKVI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VITRAKVI for a condition for which it was not prescribed. Do not give VITRAKVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about VITRAKVI that is written for health professionals.
What are the ingredients in VITRAKVI?
Active ingredient: larotrectinib
Inactive ingredients:
Capsule: gelatin, titanium dioxide and edible ink
Oral Solution Packaged in One Bottle Containing 100 mL: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.
Oral Solution Packaged in Two Bottles Each Containing 50 mL: purified water, hydroxypropyl betadex, sucralose, sodium citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.
OVERDOSE
If you take too much VITRAKVI, call your healthcare provider or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room, right away.
MISSED DOSE
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 regularly scheduled time.
STORAGE
Store VITRAKVI capsules at room temperature between 68-degrees F to 77-degrees (20-degrees C to 25-degrees C).
Store VITRAKVI oral solution in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C). Do not freeze.
Throw away (dispose of) any unused VITRAKVI oral solution:
Bottle of 100 mL: remaining 90 days after first opening the bottle
Bottle of 50 mL: remaining 31 days after first opening the bottle
Keep VITRAKVI and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 04/2025
Prescribing Information: revision date 04/2025
1.) Effects of Other Drugs on VITRAKVI
Strong and Moderate CYP3A4 Inhibitors
Coadministration of VITRAKVI with a strong or moderate CYP3A4 inhibitor may increase larotrectinib plasma concentrations, which may result in a higher incidence of adverse reactions. Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors, including grapefruit or grapefruit juice. If coadministration of strong CYP3A4 inhibitors cannot be avoided, modify VITRAKVI dose as recommended. In patients coadministered a moderate CYP3A4 inhibitor with VITRAKVI, monitor for adverse reactions more frequently and reduce the VITRAKVI dosage based on the severity of emergent adverse reactions.
Strong and Moderate CYP3A4 Inducers
Coadministration of VITRAKVI with a strong or moderate CYP3A4 inducer may decrease larotrectinib plasma concentrations, which may decrease the efficacy of VITRAKVI. Avoid coadministration of VITRAKVI with strong CYP3A4 inducers, including St. John’s wort. If coadministration of strong CYP3A4 inducers cannot be avoided, modify VITRAKVI dose as recommended. For coadministration with moderate CYP3A4 inducers, modify VITRAKVI dose as recommended.
2.) Effects of VITRAKVI on Other Drugs
Sensitive CYP3A4 Substrates
Coadministration of VITRAKVI with sensitive CYP3A4 substrates may increase their plasma concentrations, which may increase the incidence or severity of adverse reactions. Avoid coadministration of VITRAKVI with sensitive CYP3A4 substrates. If coadministration of these sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs.
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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the counter 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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
