Vitrakvi: Uses, Side Effects and Dosage

What VITRAKVI is used for:

What is a Notice of Compliance with Conditions (NOC/c)?

A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.

Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.

Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.

How VITRAKVI works:

TRK fusion cancer always has a change in a gene called “Neurotrophic Tyrosine Receptor Kinase” (NTRK). The alteration in this gene causes the body to make a protein called “TRK fusion”. TRK fusion proteins can lead to uncontrolled cell growth and cancer.

VITRAKVI stops the TRK fusion proteins from working and may slow or stop the cancer from growing. It may also help to shrink the cancer.

The ingredients in VITRAKVI are:

Medicinal ingredient: larotrectinib (as larotrectinib sulfate)

Capsules

Non-medicinal ingredients: ammonia solution, dimethicone, FD&C Blue #2 aluminum lake, gelatin, propylene glycol, shellac, titanium dioxide.

Oral Solution

Non-medicinal ingredients: citric acid, hydroxypropyl betadex, purified water, sodium benzoate, sodium citrate, strawberry flavour, sucralose.

VITRAKVI comes in the following dosage forms:

Capsules: 25 mg and 100 mg

Oral solution: 20 mg/mL

Do not use VITRAKVI if:

• you are allergic to larotrectinib or any of the other ingredients of this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VITRAKVI. Talk about any health conditions or problems you may have including if you:

• Have liver disease

Other warnings you should know about:

Take VITRAKVI only under the care of a doctor who knows how to use anti-cancer drugs.

Female Patients: Pregnancy and Breast-feeding Information

Talk to your healthcare provider before taking VITRAKVI if you are pregnant, may become pregnant or are breast-feeding.

• Avoid getting pregnant when on VITRAKVI. There may be a risk of harm or birth defects to the baby.
• Before starting on VITRAKVI, your doctor should make sure that you are not pregnant.
• Use effective birth control while taking VITRAKVI and for at least one month after the last dose. Ask your doctor about the best birth control method for you.

Tell your doctor right away if you become pregnant while taking VITRAKVI or in the first month after your last dose.

It is not known if VITRAKVI passes into breast milk. Do not breast-feed while taking VITRAKVI and for one week after the last dose.

Male Patients: Do not father a child while VITRAKVI is in your body

Avoid fathering a child by using effective birth control methods. Do this during treatment with VITRAKVI and for at least one month after the final dose.

Sodium benzoate: VITRAKVI oral solution contains 2 mg of sodium benzoate in each mL of oral solution. It may increase the risk of jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

Driving and Using Machines

VITRAKVI may cause Neurologic/Psychiatric Reactions. This may make you feel dizzy or tired. It may affect your ability to walk and think clearly. If this happens, do not drive, cycle, or operate machinery. Wait until you know how you react to VITRAKVI before you do tasks which require special attention.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Some medicines can affect the level of VITRAKVI in your body. Also, VITRAKVI can affect the way some other medicines work. The medicines listed here may not be the only ones that could interact with VITRAKVI.

The following may interact with VITRAKVI:

• itraconazole, ketoconazole, posaconazole, voriconazole, and clarithromycin – used to treat fungal and bacterial infections
• atazanavir, nelfinavir, rifabutin, ritonavir, saquinavir, and efavirenz – used to treat HIV infection
• phenytoin, carbamazepine, phenobarbital – used to treat seizures
• St. John’s wort – a herbal medicine, used to treat depression
• rifampin – used to treat bacterial infections
• cyclosporine, sirolimus, tacrolimus – used to prevent organ rejection in patients after transplantation
• quinidine – used to treat abnormal heart rhythms
• dihydroergotamine – used to treat migraine or cluster headache attack
• fentanyl – used for the treatment of chronic pain
• pimozide – an antipsychotic drug used to control motor or verbal tics

Avoid having grapefruit or its juice while on VITRAKVI. They may increase larotrectinib levels in your blood.

How to take VITRAKVI:

• Take exactly as prescribed for you by your healthcare provider. Continue to take VITRAKVI unless your healthcare provider tells you to stop. Treatment may continue as long as it is helpful to you.
• If you can’t take it as prescribed, or you feel you do not need it anymore, contact your healthcare provider right away.
• The total daily dose is usually divided in two and given twice a day. Some adults may get a reduced dose prescribed once a day.

• Take with or without food.

VITRAKVI is available as a capsule or oral solution. The capsules and oral solution are interchangeable. Your doctor will prescribe the correct dose.

• To take a VITRAKVI dose by:

  • Capsule: swallow whole with water. Do NOT open, chew, or crush.
  • Oral solution: swallow it by mouth or take it through a feeding tube. Always use a dosing syringe to measure the dose. Ask your pharmacist where to get a suitable dosing syringe.

Usual dose:

Depends on if you are a child or an adult. Your healthcare professional will monitor your condition. Your doctor may interrupt, reduce, increase, or stop your dose. This may occur based on your current health, if you have liver disease, take other medications, if your disease gets worse, or if you have too many side effects.

Child Usual Daily Dose:

Your child’s healthcare provider will work out the right daily dose in milligrams for your child. It is based on the child’s height and weight. The daily prescribed amount is then divided in two and given twice a day. They can take:

• Capsule(s): by mouth.

  or

• Oral Solution: by mouth or through a feeding tube.

Adult (from 18 years old) Usual Daily Dose 200 mg:

• Capsule(s) 100 mg by mouth twice a day.

  or

• Oral Solution: 5 mL (100 mg) twice a day by mouth or through a feeding tube.

Child and Adult Maximum Daily Dose 200 mg: 100 mg twice a day from capsules or the oral solution.

Overdose:

Missed dose:

If you miss a dose, take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you or your child vomits (are sick) after taking VITRAKVI, just take the next dose at the usual time.

Possible side effects from using VITRAKVI:

These are not all the possible side effects you may feel when taking VITRAKVI. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• feeling tired or weak
• headache
• fever
• nausea, vomiting, constipation, diarrhea
• cough, shortness of breath, stuffy nose
• swelling or pain of arms, legs, hands, or feet
• muscle weakness
• muscle, joints, abdominal, or back pain
• decreased appetite
• taste changes
• weight gain
• rash
• high blood pressure

VITRAKVI can cause abnormal physical exam and blood test results. Your doctor will do some tests before, during and after your treatment. These tests include checking for Neurologic/Psychiatric Reactions and any Liver Problems. The doctor will interpret the results. They will tell you if there are any abnormalities in your tests that might need treatment.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

• For capsules:

  • Store at room temperature 15 to 30°C.

• For oral solution

  • Store at 2°C to 8°C. Keep refrigerated. Do not freeze.
  • Discard 30 days after first opening.
• Keep out of reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the carton and the bottle label after “EXP”. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If you want more information about VITRAKVI:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.bayer.ca; or by calling Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

  Bayer Inc.

  2920 Matheson Blvd East

  Mississauga, Ontario

  L4W 5R6

  Canada

Date of Authorization: 2026-08-26

© 2026, Bayer Inc.

® TM see www.bayer.ca/tm-mc