Multikinase inhibitors
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Larotrectinib Dosage

Drug Detail:Larotrectinib (Larotrectinib [ lar-oh-trek-ti-nib ])

Drug Class: Multikinase inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Usual Adult Dose for Solid Tumors

Body surface area least 1 m2:
100 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:

  • Select patients for treatment with this drug based on the presence of a NTRK gene fusion in tumor specimens.

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 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:
  • Select patients for treatment with this drug based on the presence of a NTRK gene fusion in tumor specimens.

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

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

  • Mild hepatic impairment (Child-Pugh A): No adjustment recommended.
  • Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment: Reduce the initial dose by 50%.

Dose Adjustments

Recommended Dose Modifications for Adverse Reactions:
FIRST DOSE REDUCTION:

  • Adult and pediatric patients with body surface area (BSA) of at least 1 m2: Reduce dose to 75 mg orally 2 times a day.
  • Pediatric patients with BSA less than 1 m2: Reduce dose to 75 mg/m2 orally 2 times a day.
SECOND DOSE REDUCTION:
  • Adult and pediatric patients with BSA of at least 1 m2: Reduce dose to 50 mg orally 2 times a day.
  • Pediatric patients with BSA less than 1 m2: Reduce dose to 50 mg/m2 orally 2 times a day.
THIRD DOSE REDUCTION:
  • Adult and pediatric patients with BSA of at least 1 m2: Reduce dose to 100 mg orally once a day.
  • Pediatric patients with BSA less than 1 m2: Reduce dose to 25 mg/m2 orally 2 times a day.

Permanently discontinue therapy in patients who are unable to tolerate this drug after 3 dose modifications.

Dose Modifications for Coadministration with Strong CYP450 3A4 Inhibitors:
  • Avoid coadministration of strong CYP450 3A4 inhibitors with this drug
  • If coadministration cannot be avoided, reduce the dose of this drug by 50%
  • After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the dose of this drug taken prior to initiating the CYP450 3A4 inhibitor.

Dose Modifications for Coadministration with Strong CYP450 3A4 Inducers:
  • Avoid coadministration of strong CYP450 3A4 inducers with this drug.
  • If coadministration cannot be avoided, double the dose of this drug.
  • After the inducer has been discontinued for 3 to 5 elimination half-lives, resume the dose of this drug taken prior to initiating the CYP450 3A4 inducer.

Dosage Modifications for Adverse Reactions:
FOR GRADE 3 OR 4 ADVERSE REACTIONS:
  • Withhold therapy until adverse reaction resolves or improves to baseline or Grade 1.
  • Resume at the next dosage modification if resolution occurs within 4 weeks.
  • Permanently discontinue therapy if an adverse reaction does not resolve within 4 weeks.

Precautions

CONTRAINDICATIONS:

  • None

Safety and efficacy have not been established in patients less than 28 days old.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • This drug may be taken with or without food.
  • The capsule or oral solution may be used interchangeably.
  • Do not make up a missed dose within 6 hours of the next scheduled dose.
  • If vomiting occurs after taking a dose, take the next dose at the scheduled time.
  • Swallow capsules whole with water. Do not chew or crush.
  • Discard any unused oral solution remaining after 90 days of first opening the bottle.
  • Prior to preparing an oral dose for administration, refer to the instructions for use.

Storage requirements:
  • Store capsules at room temperature 20C to 25C (68F to 77F); temperature excursions between 15C and 30C (59F to 86F) are permitted.
  • Store the oral solution in the refrigerator at 2C to 8C (36F to 46F); do not freeze.

Monitoring:
  • Liver function tests.

Patient advice:
  • Read the approved patient labeling.
  • Notify your healthcare provider if you experience new or worsening
neurotoxicity.
  • Do not drive or operate hazardous machinery if you are experiencing neurologic adverse reactions.
  • This drug can harm a developing fetus.
  • Males and females of reproductive potential should use effective contraception during therapy with this drug and for at least 1 week after.
  • Inform your healthcare provider of a known or suspected pregnancy.

Frequently asked questions

  • What type of drug is Vitrakvi (larotrectinib)?
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