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216993s000lbl.pdf
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👤 Author: fda/cder
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Summary

VANFLYTA (quizartinib) is a kinase inhibitor for oral use, initially approved in the US in 2023. It is indicated for treating adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive. The treatment is in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy. VANFLYTA has a warning for QT prolongation, torsades de pointes, and cardiac arrest, and its use is restricted through a Risk Evaluation and Mitigation Strategy (REMS) due to these risks. Contraindications include severe hypokalemia, severe hypomagnesemia, long QT syndrome, and history of ventricular arrhythmias or torsades de pointes. Common adverse reactions include lymphocytes decreased, potassium decreased, and febrile neutropenia.

Description

VANFLYTA (quizartinib) is a kinase inhibitor for oral use, initially approved in the US in 2023.

Technical Information

  • File Format: PDF
  • File Size: 778 KB
  • Pages: 22
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 119
  • Last Updated: 3 weeks ago

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