r tests including ALT and AST every 2 weeksduring the first month of treatment, then monthly thereafter and asclinically indicated. Withhold and modify dosage, or permanentlydiscontinue VITRAKVI based on severity. (2.6, 5.2)
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females withreproductive potential of potential risk to the fetus and to use effectivecontraception. (5.3, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) with VITRAKVI were fatiguenausea, dizziness, vomiting, increased AST, cough, increased ALT,constipation, and diarrhea. (6).
To report SUSPECTED ADVERSE REACTIONS, contact BayerHealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4inhibitors with VITRAKVI. If coadministration cannot be avoided, reducethe VITRAKVI dose. (2.4, 7.1)
• Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4inducers with VITRAKVI. If coadministration cannot be avoided, increasethe VITRAKVI dose. (2.5, 7.1)
• Sensitive CYP3A4 Substrates: Avoid coadministration of sensitiveCYP3A4 substrates with VITRAKVI. (7.2)
USE IN SPECIFIC POPULATIONS
• Lactation: Advise not to breastfeed. (8.2)
• Hepatic Impairment: Reduce the starting dose of VITRAKVI in patientswith moderate (Child-Pugh B) to severe (Child-Pugh C) hepaticimpairment. (2.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION andFDA-approved patient labeling
Revised: 11/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosage
2.3 Dosage Modifications for Adverse Reactions
2.4 Dosage Modifications for Coadministration with Strong CYP3A4
Inhibitors
2.5 Dosage Modifications for Coadministration with Strong CYP3A4
Inducers
2.6 Dosage Modifications for Patients with Hepatic Impairment
2.7 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Neurotoxicity
5.2 Hepatotoxicity
5.3 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on VITRAKVI
7.2 Effects of VITRAKVI on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:
• have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquiredresistance mutation,
• are metastatic or where surgical resection is likely to result in severe morbi |
