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Vitrakvi

Vitrakvi

larotrectinib

Manufacturer:

Bayer

Distributor:

Zuellig
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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. Confirm NTRK gene fusion in a tumor specimen using a validated test before treatment.
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Dosage/Direction for Use
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. Patients 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: Swallow whole, do not open/chew/crush.
Contraindications
Hypersensitivity.
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Special Precautions
Can cause transaminase elevations. Monitor liver function including ALT & AST assessments. Neurologic/psychiatric treatment-emergent adverse events. May influence ability to drive & use machines. Advise female patients 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 to a pregnant woman. Discontinue breastfeeding during treatment & for 1 wk following final dose.
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Adverse Reactions
Fatigue, nausea, dizziness, vomiting, anemia, ALT & AST increased, cough, constipation, diarrhea.
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Drug Interactions
Increased plasma conc w/ strong CYP3A inhibitors, P-gp & BCRP inhibitors (eg, itraconazole). Avoid co-administration w/ strong CYP3A4 inhibitors (eg, atazanavir, clarithromycin, itraconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, or voriconazole); grapefruit or grapefruit juice. Decreased plasma conc w/ strong CYP3A & P-gp inducers (eg, rifampin). Avoid co-administration w/ strong CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifabutin, or rifampin); St. John's wort. Increased Cmax & 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.
Presentation/Packing
Form
Vitrakvi cap 25 mg
Packing/Price
56's
Form
Vitrakvi cap 100 mg
Packing/Price
56's
Form
Vitrakvi oral soln 20 mg/mL
Packing/Price
1's
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