Vitrakvi Dosage/Direction for Use

Dosing Considerations: Confirm the presence of an NTRK gene fusion in a tumour specimen using a validated test prior to initiation of treatment with VITRAKVI (see Pharmacology: Mechanism of Action under Actions).
Recommended Dose and Dosage Adjustment: Adults: The recommended dose of VITRAKVI in adults is 100 mg taken orally, twice daily (total dose of 200 mg) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Pediatrics: Dosing in pediatric patients is based on body surface area (BSA). The recommended dose of VITRAKVI in pediatric patients (1 month to 18 years) is 100 mg/m² taken orally, twice daily with a maximum of 100 mg per dose (maximum total dose of 200 mg) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. For those subjects following the BSA-based dosing algorithm (mg/m²), oral solution dose volumes under 1.0 mL can be rounded to the nearest 0.1 mL. Oral solution dose volumes above 1.0 mL can be rounded to the nearest 0.5 mL.
Geriatrics: Clinical data indicate that age has no effect on the systemic exposure of larotrectinib (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Geriatrics under Actions). No dose adjustment is necessary in elderly patients.
Patients with Hepatic Impairment: Clinical data from a pharmacokinetic study indicate that larotrectinib exposure was increased in patients with hepatic impairment up to 3.2-fold (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Hepatic Insufficiency under Actions). Reduce the starting dose of VITRAKVI by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment. No dose adjustment is recommended for patients with mild (Child-Pugh A) hepatic impairment.
Patients with Renal Impairment: Clinical data from a pharmacokinetic study indicate that larotrectinib exposure was increased 1.46-fold in patients with end-stage renal disease (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Renal Insufficiency under Actions). No dose adjustment is required for patients with renal impairment.
Dose Modifications: For an adverse reaction ≥ Grade 3, consider interrupting dosing of VITRAKVI and reevaluating regularly at least weekly. VITRAKVI can be withheld for up to 4 weeks to allow recovery to Grade 1 or back to baseline and resumed at the next dosage modification. Permanently discontinue VITRAKVI if an adverse reaction does not resolve within 4 weeks of the start of withholding the dose.
Recommended dose modifications for VITRAKVI for adverse reactions are provided in Table 7. (See Table 7.)

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Permanently discontinue VITRAKVI in patients who are unable to tolerate VITRAKVI after three dose modifications.
For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised.
Administration: VITRAKVI is for oral use and may be administered with or without food. VITRAKVI is available as a capsule or oral solution formulation with equivalent oral bioavailability, and may be used interchangeably.
Capsule: The patient should be advised to swallow the capsule whole with water. The capsule should not be opened, chewed, or crushed.
Oral solution: Administer the oral solution by mouth or enterally by naso- or gastric-feeding tube with a dosing syringe.
Missed Dose: If a dose is missed, the patient should not take two doses at the same time to make up for a missed dose. Patients should take the next dose at the next scheduled time.
If the patient vomits after taking a dose, the patient should not take an additional dose to make up for vomiting.