Vitrakvi Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Larotrectinib

Indications/Uses

Treatment of adult & ped patients w/ solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion w/o a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, & have no satisfactory treatment options.

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Dosage/Direction for Use

Confirm presence of NTRK gene fusion in a tumour specimen using a validated test prior to treatment initiation. Adult 100 mg bd (total dose 200 mg) until no clinical benefit from therapy or unacceptable toxicity. Ped patient 1 mth to 18 yr 100 mg/m² bd w/ a max of 100 mg/dose (max total dose 200 mg) until no clinical benefit from therapy or unacceptable toxicity. Patient w/ moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment Reduce starting dose by 50%.

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Overdosage

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Administration

May be taken with or without food: Hard cap: Swallow whole w/ water. Do not open/chew/crush. Oral soln: Administer by mouth or enterally by naso- or gastric-feeding tube w/ a dosing syringe.

Contraindications

Hypersensitivity.

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Special Precautions

Can cause transaminase elevations. Consider baseline assessment of liver function, including transaminase levels, before the 1st dose & mthly for the 1st 3 mth of treatment, then periodically during treatment, w/ more frequent testing in patients who develop transaminase elevations. Risk of neurologic/psychiatric treatment-emergent adverse events. May influence ability to drive & use machines. Advise females of reproductive potential & males of reproductive potential w/ a non-pregnant female partner of child-bearing potential to use highly effective contraception during treatment & for at least 1 mth after the final dose. Risk of fetal harm when administered to a pregnant woman. Discontinue breastfeeding during treatment & for 1 wk following final dose. No data in ped patients <1 mth of age. Oral soln: Contains Na benzoate which may increase jaundice in newborn babies (up to 4 wk old).

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue, cough, increased ALT, constipation, diarrhea, dizziness, anemia, increased AST, vomiting, nausea, pyrexia.

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Drug Interactions

Increased plasma conc w/ strong CYP3A inhibitors, P-gp & BCRP inhibitors. Avoid co-administration w/ strong CYP3A4 inhibitors (eg, atazanavir, clarithromycin, itraconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, voriconazole, grapefruit or grapefruit juice). Decreased plasma conc w/ strong CYP3A & P-gp inducers. Avoid co-administration w/ strong CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifabutin, or rifampin); St. John's wort. Increased C_max & AUC of midazolam (sensitive CYP3A substrate). Exercise caution w/ concomitant use of CYP3A substrates w/ narrow therapeutic range (eg, fentanyl, cyclosporine, dihydroergotamine, pimozide, quinidine, sirolimus, or tacrolimus).

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Storage

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Description

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Action

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MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX12 - larotrectinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Vitrakvi hard cap 25 mg

Packing/Price

56's

Form

Vitrakvi hard cap 100 mg

Packing/Price

56's

Form

Vitrakvi oral soln 20 mg/mL

Packing/Price

50 mL x 2 × 1's

Vitrakvi

larotrectinib

Manufacturer:

Bayer

Distributor:

Zuellig