Loxo Oncology, Inc.
Treatment For: TRK Fusion Cancers
Vitrakvi (larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins. Capsules
25 mg: Hard gelatin opaque white capsule size #2 with blue printing of "LOXO" and "LARO 25 mg" on the body of the capsule.
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60 count bottle NDC# 71777-390-01
100 mg: Hard gelatin opaque white capsule size #0 with blue printing of "LOXO" and "LARO 100 mg" on the body of the capsule.
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60 count bottle NDC# 71777-391-01
Store capsules at room temperature 20�C to 25�C (68�F to 77�F); temperature excursions between 15�C and 30�C (59�F to 86�F) are permitted [see USP Controlled Room Temperature].
Oral Solution
20 mg/mL: Clear yellow to orange solution.
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100 mL bottle NDC# 71777-392-01
Refrigerate oral solution at 2�C to 8�C (36�F to 46�F). Do not freeze. hese highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI.
VITRAKVI� (larotrectinib) capsules, for oral use
VITRAKVI� (larotrectinib) oral solution
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that:
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have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
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are metastatic or where surgical resection is likely to result in severe morbidity, and
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have no satisfactory alternative treatments or that have progressed following treatment.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials (1,14).
DOSAGE AND ADMINISTRATION
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Select patients for treatment with VITRAKVI based on the presence of a NTRK gene fusion (2.1, 14).
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Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared: 100 mg orally twice daily (2.2)
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Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1.0 Meter-Squared: 100 mg/m2 orally twice daily (2.2)
DOSAGE FORMS AND STRENGTHS
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Capsules: 25 mg, 100 mg (3)
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Oral Solution: 20 mg/mL (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Neurotoxicity: Advise patients and caretakers of the risk of neurologic adverse reactions. Advise patients not to drive or operate hazardous machinery if experiencing neurotoxicity. Withhold and modify dosage, or permanently discontinue VITRAKVI based on severity. (2.3, 5.1)
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Hepatotoxicity: Monitor liver tests including ALT and AST every 2 weeks during the first month of treatment, then monthly thereafter and as clinically indicated. Withhold and modify dosage, or permanently discontinue VITRAKVI based on severity. (2.6, 5.2)
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective contraception. (5.3, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (? 20%) with VITRAKVI were fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation, and diarrhea. (6).
To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4 inhibitors with VITRAKVI. If coadministration cannot be avoided, reduce the VITRAKVI dose. (2.4, 7.1)
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Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4 inducers with VITRAKVI. If coadministration cannot be avoided, increase the VITRAKVI dose. (2.5, 7.1)
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Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with VITRAKVI. (7.2)
USE IN SPECIFIC POPULATIONS
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Lactation: Advise not to breastfeed. (8.2)
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Hepatic Impairment: Reduce the starting dose of VITRAKVI in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment. (2.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 12/2018
