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Vitrakvi is the brand name for larotrectinib oral capsules and solution.

Vitrakvi is available as a 25 mg and 100 mg oral capsule and a 20 mg/mL oral solution.

Vitrakvi is a kinase inhibitor indicated for the treatment of adult andpediatric 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

Vitrakvi works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

Vitrakvi is dosed as follows:

• Recommended Dosage in Adult and Pediatric Patients with Body Surface
• Area of 1 Meter-Squared or greater: 100 mg orally twice daily
• Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1 Meter-Squared: 100 mg/m2 orally twice daily

Vitrakvi is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Vitrakvi:

• Cough
• Leukopenia
• Constipation
• Diarrhea
• Dizziness
• Hypocalcemia
• Nausea
• Vomiting
• Fever
• Abdominal pain

Serious side effects are rare with Vitrakvi. Contact your doctor if you experience any of the following.

• Central nervous system (CNS) problems: dizziness, confusion, problems with concentration, attention, and memory, changes in your mood, and sleep
  problems
• Bone fractures: pain, changes in your ability to move around, or bone abnormalities
• Liver problems: yellowing of your skin or the white part of your eyes (jaundice), dark or brown urine, bruising or bleeding more easily than normal, tiredness, pain in the upper right side of your stomach area (abdomen), nausea or vomiting

• The following medications may interact with Vitrakvi:
• Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4 inhibitors with Vitrakvi. If coadministration cannot be avoided, reduce the Vitrakvi dose.
• Moderate CYP3A4 Inhibitors: Monitor for adverse reactions more frequently in patients coadministered a moderate CYP3A4 inhibitor with Vitrakvi and reduce the Vitrakvi dosage based on severity of adverse reactions
• Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4 inducers with Vitrakvi. If coadministration cannot be avoided, increase
• the Vitrakvi dose
• Moderate CYP3A4 Inducers: Increase the Vitrakvi dose
• Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with Vitrakvi

Bayer Healthcare

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.
If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Vitrakvi. Females who are able to become pregnant 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 should use effective birth control during treatment with Vitrakvi and for 1 week after the last dose of
Vitrakvi. Vitrakvi may affect fertility in females and may affect your ability to become pregnant.

• Larotrectinib