Vitrakvi

Generic name: Larotrectinib
Drug class: Multikinase inhibitors

Usage of Vitrakvi

Vitrakvi is a prescription medicine used to treat certain tumors that are caused by an abnormal "NTRK" gene. Larotrectinib is used when the cancer has spread to other parts of the body or cannot be removed with surgery or other cancer treatments.

Vitrakvi is sometimes given after other cancer treatments did not work or have stopped working.

Vitrakvi was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Vitrakvi side effects

Get emergency medical help if you have signs of an allergic reaction to Vitrakvi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe or ongoing stomach pain, vomiting, or diarrhea;

confusion, memory problems, severe dizziness;

problems with speech or coordination;

numbness, tingling, or burning pain in your hands or feet;

fever, flu symptoms, sore throat, cough;

sores or ulcers in your mouth or on your skin;

unusual tiredness, feeling light-headed or short of breath;

pale skin, cold hands and feet;

pain, warmth, redness, or swelling under your skin; or

liver problems - loss of appetite, stomach pain (upper right side), nausea, vomiting, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Vitrakvi side effects may include:

nausea, vomiting, diarrhea, constipation;

cough;

dizziness;

tiredness; or

abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Vitrakvi

To make sure Vitrakvi is safe for you, tell your doctor if you have ever had:

liver disease; or

nerve problems.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Larotrectinib can harm an unborn baby or cause birth defects if the mother or father is using this medicine. Keep using birth control for at least 1 week after your last dose.

Vitrakvi may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because larotrectinib can harm an unborn baby.

Do not breast-feed while using Vitrakvi, and for at least 1 week after your last dose.

Relate drugs

How to use Vitrakvi

Usual Adult Dose of Vitrakvi for Solid Tumors:

Body surface area least 1 m2: 100 mg orally 2 times a day until disease progression or unacceptable toxicity Comments: -Take this drug with or without food. -Select patients for treatment with this drug based on the presence of a NTRK gene fusion in tumor specimens. An FDA-approved test for the detection of NTRK gene fusion is not currently available. Use: For the treatment of adult patients with solid tumors that: -Have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation -Are metastatic or where surgical resection is likely to result in severe morbidity -Have no satisfactory alternative treatments or that have progressed following treatment

Usual Pediatric Dose of Vitrakvi for Solid Tumors:

28 days and older: -Body surface area at least 1 m2: 100 mg orally 2 times a day until disease progression or unacceptable toxicity -Body surface area less than 1 m2: 100 mg/m2 orally 2 times a day until disease progression or unacceptable toxicity. Comments: -Take this drug with or without food. -Select patients for treatment with this drug based on the presence of a NTRK gene fusion in tumor specimens. An FDA-approved test for the detection of NTRK gene fusion is not currently available. Use: For the treatment of pediatric patients with solid tumors that: -Have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation -Are metastatic or where surgical resection is likely to result in severe morbidity -Have no satisfactory alternative treatments or that have progressed following treatment

Warnings

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.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Certain other medicines may affect how larotrectinib works. Keep a list of all your medicines to show your healthcare provider and pharmacist.

What other drugs will affect Vitrakvi

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with larotrectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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