Quizartinib is an innovative kinase inhibitor that received its first approval in the United States in 2023.

What are the Indications of Quizartinib?

Primary Therapeutic Area

Quizartinib is a kinase inhibitor.

It is used in the treatment of adult patients with newly diagnosed FLT3 internal tandem duplication (ITD)-positive acute myeloid leukemia (AML). The treatment regimen involves combination with standard cytarabine and anthracycline-based induction therapy, followed by cytarabine-based consolidation therapy, and subsequent use as a single-agent maintenance therapy after consolidation chemotherapy.

Patient Selection Criteria

Patients selected for AML treatment with VANFLYTA (the brand name of Quizartinib) should be based on detected positive FLT3-ITD mutation.

The FLT3-ITD status must be prospectively determined using a test method approved by the U.S. Food and Drug Administration (FDA).

Specifications and Properties of Quizartinib

Dosage Form and Specifications

17.7 mg tablet: Contains 17.7 mg of quizartinib, equivalent to 20 mg of quizartinib dihydrochloride. The tablet is white, round, film-coated, and imprinted with "DSC511".

26.5 mg tablet: Contains 26.5 mg of quizartinib, equivalent to 30 mg of quizartinib dihydrochloride. The tablet is yellow, round, film-coated, and imprinted with "DSC512".

Chemical Composition

The chemical name of quizartinib dihydrochloride is 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-(4-{7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl}phenyl)urea dihydrochloride.

Its molecular formula is C₂₉H₃₂N₆O₄S•2HCl, with a molecular weight of 633.6 (in salt form) and 560.7 (in free base form).

Core Tablet Ingredients

Hydroxypropyl betadex.

Microcrystalline cellulose.

Magnesium stearate.

Film-Coating Materials.

For 17.7 mg tablets: Hypromellose, talc, triacetin, and titanium dioxide.

For 26.5 mg tablets: All the ingredients of the 17.7 mg tablet coating, plus iron oxide as a colorant.

Storage Methods for Quizartinib

Standard Storage Conditions

Quizartinib must be stored at 20°C to 25°C (68°F to 77°F). Short-term storage within the range of 15°C to 30°C (59°F to 86°F) is permitted.

Packaging Protection Features

The medication is packaged in child-resistant caps, available in two specifications: 14-tablet bottles and 28-tablet bottles.

Bottle Design

Equipped with a silica gel desiccant.

Contains a polyester coil.

Protected with a child-resistant cap.

Key Storage Points

The bottle must be kept tightly closed at all times.

The medication should be stored in its original container; do not transfer it to other containers.

Ensure the medication is always kept out of the reach of children.

Dispensing and Usage Specifications

The medication may only be dispensed in its original container.

Keep the medication in a controlled room temperature environment.