Larotrectinib Dosage
Medically reviewed by Drugs.com. Last updated on Dec 29, 2023.
Applies to the following strengths: 25 mg; 100 mg; 20 mg/mL
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
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.
- 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.
- 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
- 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.
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