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What is Vitrakvi (larotrectinib)?

In November 2018, the US Food and Drug Administration (FDA) approved a new oncology drug called larotrectinib, brand name Vitrakvi. It was the first drug known as a “tissue agnostic” drug, which means it can be used to treat different types of cancer, as long as they all have the same biomarker. This drug can be used in both adults and children whose solid tumor cancers test positive for NTRK genes, cannot be surgically removed, and have progressed during other types of treatment.1

Tissue agnostic drugs are an exciting new breakthrough in cancer treatment because scientists are looking at the biology of the cancer, instead of merely the type of cancer, allowing for more specialized and targeted treatments. This will hopefully translate into more effective treatment, resulting in better quality of life.

What are the ingredients in Vitrakvi?

The capsules of Vitrakvi have the active ingredient larotrectinib sulfate enclosed in a hard gelatin capsule.2 Ingredients in the capsule include gelatin, titanium dioxide, and edible ink.2 The oral solution contains larotrectinib sulfate as the active ingredient, and inactive ingredients include: citric acid, sorbitol, purified water, hydroxypropyl betadex, sucrose, glycerin, sodium phosphate, sodium citrate dihydrate, propylene glycol, and flavoring.2 Preservatives include methylparaben and potassium sorbate.2

How does Vitrakvi work?

Vitrakvi inhibits tropomyosin receptor kinases, which are encoded by genes like NTRK1, NTRK2, and NTRK3.2 When there are mutations in these genes, these can facilitate oncogenic changes, leading to the development of cancer.2 Vitrakvi shows anti-tumor activity in cells in which these mutated genes occur.

What are the possible side effects of Vitrakvi?

As with any medication, when taking Vitrakvi, adverse effects may occur. The most commonly seen side effects of Vitrakvi include fatigue, peripheral swelling, increase in body temperature, nausea and vomiting, diarrhea, abdominal pain, dizziness, headache, cough, weight gain, muscle pain or weakness, joint pain, and hypertension.2 Laboratory counts may be affected as well, especially liver enzymes.

Neurological side effects noted during clinical trials included delirum, slurred or slowed speech, gait issues, memory impairment, and paresthesia.2

Things to know about Vitrakvi

If you are pregnant or breastfeeding, you should not take Vitrakvi, as it can harm a developing fetus or newborn baby.2

Because of the changes in laboratory tests (especially enzyme levels in the liver), individuals taking this medication should get ALT and AST levels checked every two weeks in the first month of taking Vitrakvi, and then monthly and as needed after that.3

This drug may interact with other medications. Tell your doctor about any other medication, drug, vitamin, over-the-counter drugs, or supplement that you take. While taking Vitrakvi, do not take St. John’s wort, eat grapefruit, or drink grapefruit juice.2

Vitrakvi may impair fertility in female individuals, so talk with your doctor if you have any concerns about this.2

Dosing information

For adults and children who have a body surface area of at least 1.0 meter-squared, the recommended dosage is 100 mg twice daily, taken orally.2 This can be taken with or without food, and should be taken until the disease progresses or until the side effects get to be too much to tolerate.2

For children with a body surface area less than 1.0 meter-squared, the recommended dosage of Vitrakvi is 100 mg/m2 twice daily, taken orally.2 This can be taken with or without food until the disease progresses or until the side effects are intolerable.2

If adverse reactions occur, depending on the severity of the adverse reaction, dosage modifications might need to be made. It’s not recommended that Vitrakvi be taken with strong CYP3A4 inhibitors, but if this is unavoidable, dosage modifications for coadministration should be made.2 Your doctor will talk with you further about what modifications and dosing schedules will be like.

This drug can be taken by capsule or by oral solution and can be used interchangeably. Capsules should be taken whole with water and not broken or crushed.2 The oral solution should be kept refrigerated and be disposed of within 90 days of opening the bottle.

For more information, read the full prescribing information of Vitrakvi.

Last reviewed: October 2019
  1. FDA Approves Vitrakvi (Larotrectinib) for Tumors with Certain Genetic Change. American Cancer Society. Published November 28, 2018. Accessed October 23, 2019.
  2. Vitrakvi prescribing information. Published November 2018. Accessed October 23, 2019.
  3. FDA Approves an Oncology Drug That Targets a Key Genetic Driver of Cancer, Rather Than a Specific Tumor. US Food and Drug Administration. Published November 26, 2018. Accessed October 23, 2019.