What is VANFLYTA used for?

1 INDICATIONS AND USAGE VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ] . VANFLYTA is a kinase inh

How does VANFLYTA work?

11 DESCRIPTION VANFLYTA (quizartinib) is a kinase inhibitor for oral use.

What pharmaceutical form is VANFLYTA available in?

VANFLYTA: Tabletki powlekane 17,7 mg (doustna)

What are the side effects of VANFLYTA?

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation, Torsades de Pointes, and Cardiac Arrest [see Warnings and Precautions (5.1) ] The most common (>20%) adverse reactions, including laboratory abnormalities, are lymphocytes decreased, potassium decreased, albumin decreased, phosphorus decreased, alkaline phosphatase increased, magnesium decreased, febrile neutropenia, diarrhea, mucositis, nausea, calcium decreased,

Who should NOT take VANFLYTA?

4 CONTRAINDICATIONS VANFLYTA is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes [see Warnings and Precautions (5.1) ]. Contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes. ( 4 , 5.1 )

Does VANFLYTA interact with other medications?

7 DRUG INTERACTIONS Table 7: Effect of Other Drugs on VANFLYTA Strong CYP3A Inhibitors Clinical Impact VANFLYTA is a CYP3A substrate. Concomitant use of VANFLYTA with a strong CYP3A inhibitor increases quizartinib systemic exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of VANFLYTA adverse reactions. Prevention or Management Reduce the dosage of VANFLYTA [see Dosage and Administration (2.4) ]. Strong or Moderate CYP3A Inducers Clinical Impact Concomit

Can VANFLYTA be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, VANFLYTA can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on VANFLYTA use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral administration of quizartinib to pregnant rats during organog

What precautions should be taken with VANFLYTA?

This product may pose a risk to the environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures VANFLYTA?

Daiichi Sankyo Europe GmbH (Niemcy)

What ATC class does VANFLYTA belong to?

VANFLYTA: ATC L01EX11. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

VANFLYTA

17,7 mg, Tabletki powlekane

INN: Quizartinibum

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

17,7 mg

Route

doustna

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].‍‍‍‍‍ Tablet Strength Tablet Description Package Configuration NDC 17.7 mg White, round, film-coated, debossed with "DSC511" , 28-count bottle 65597-504-28 14-count bottle 65597-504-04 26.5 mg Yellow, round, film-coated, debossed with "DSC512" 28-count bottle 65597-511-28 14-count bottle 65597-511-04

User Reviews

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