VITRAKVI Label.pdf

210861s000lbl.pdf
Preview of VITRAKVI Label
🔗 Source: accessdata.fda.gov
📊 Size: 770 KB
👤 Author: fda/cder
⬇️ Downloads: 52

Summary

VITRAKVI is indicated for adult and pediatric patients with solid tumors having a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, and is administered orally at 100 mg twice daily for patients with a body surface area of at least 1.0 meter-squared, or 100 mg/m2 twice daily for pediatric patients with a body surface area less than 1.0 meter-squared, with dosage modifications for adverse reactions, and has warnings for neurotoxicity, hepatotoxicity, and embryo-fetal toxicity.

Description

VITRAKVI is indicated for adult and pediatric patients with solid tumors having a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, and is administered...

Technical Information

  • File Format: PDF
  • File Size: 770 KB
  • Pages: 20
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 52
  • Last Updated: 1 month ago

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