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

Larotrectinib 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

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

Larotrectinib 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

Larotrectinib 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 Larotrectinib:

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

Serious side effects are rare with Larotrectinib. 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 Larotrectinib:
• Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4 inhibitors with Larotrectinib. If coadministration cannot be avoided, reduce the Larotrectinib dose.
• Moderate CYP3A4 Inhibitors: Monitor for adverse reactions more frequently in patients coadministered a moderate CYP3A4 inhibitor with Larotrectinib and reduce the Larotrectinib dosage based on severity of adverse reactions
• Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4 inducers with Larotrectinib. If coadministration cannot be avoided, increase
• the Larotrectinib dose
• Moderate CYP3A4 Inducers: Increase the Larotrectinib dose
• Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with Larotrectinib

Various FDA-approved generic manufacturers

Larotrectinib can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Larotrectinib 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 Larotrectinib. Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after the last dose of Larotrectinib. 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 Larotrectinib and for 1 week after the last dose of
Larotrectinib. Larotrectinib may affect fertility in females and may affect your ability to become pregnant.

• Vitrakvi