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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 is 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.

How does larotrectinib work?

Larotrectinib 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 Larotrectinib shows anti-tumor activity in cells in which these mutated genes occur.

What are the possible side effects of larotrectinib?

As with any medication, when taking larotrectinib, adverse effects may occur. Possible side effects of larotrectinib 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. (Please note this list is not exhaustive.)

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

Things to know about larotrectinib

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

Because of the changes in laboratory tests (especially liver enzyme levels), individuals taking this medication should get ALT and AST levels checked every two weeks in the first month of taking larotrectinib, 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 larotrectinib, do not take St. John’s wort, eat grapefruit, or drink grapefruit juice.2

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

Dosing information

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. Vitrakvi may be taken with or without food. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their Vitrakvi regimen.

If adverse reactions occur, depending on the severity of the adverse reaction, dosage modifications might need to be made. It’s not recommended that larotrectinib 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.

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

Last reviewed: January 2020.
  1. FDA Approves Vitrakvi (Larotrectinib) for Tumors with Certain Genetic Change. American Cancer Society. https://www.cancer.org/latest-news/fda-approves-vitrakvi-larotrectinib-for-tumors-with-certain-genetic-change.html Published November 28, 2018. Accessed October 23, 2019.
  2. Vitrakvi prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf 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. https://www.fda.gov/news-events/press-announcements/fda-approves-oncology-drug-targets-key-genetic-driver-cancer-rather-specific-type-tumor Published November 26, 2018. Accessed October 23, 2019.