Quizartinib is an oral, selective small molecule tyrosine kinase inhibitor specifically designed for acute myeloid leukemia (AML) patients with FLT3 gene mutations.

1. Drug name

Common name: Quizartinib

Product Name: VANFLYTA ®

English name: QuizartinibTablets

2. Indications

Combined standard cytarabine and anthracycline induction chemotherapy, as well as cytarabine consolidation chemotherapy, and used as maintenance monotherapy after consolidation chemotherapy, for newly diagnosed FLT3 internal tandem repeat (ITD) positive acute myeloid leukemia (AML) in adults. Confirmation of FLT3-ITD mutation through FDA approved testing is required.

Limitation: Not applicable for maintenance monotherapy after allogeneic hematopoietic stem cell transplantation (HSCT).

3. Specifications and characteristics

Specifications:

17.7mg tablets: white circular film coated tablets engraved with "DSC511".

26.5mg tablets: yellow circular film coated tablets engraved with "DSC512".

Appearance: Thin film coated tablets, with contents ranging from white to off white powder.

4. Main components

Active ingredient: Quizartinib.

Accessories: Hydroxypropyl betacyclodextrin, microcrystalline cellulose, magnesium stearate; The coating contains hydroxypropyl methylcellulose, talc powder, triacetin, and titanium dioxide (26.5mg tablets also contain iron oxide yellow).

5. Usage and dosage

Conventional dosage:

Induction period: 35.4mg orally, once daily (starting from the 8th day of chemotherapy and lasting for 14 days).

Consolidation period: 35.4mg orally, once daily (starting from the 6th day of chemotherapy and lasting for 14 days).

Maintenance period: Initially 26.5mg once daily, if QTcF ≤ 450ms, increase to 53mg once daily on the 15th day.

Missed dose: Take a replacement within 12 hours; Skip for more than 12 hours and take the medication according to the original plan the next day.

Vomiting: No need for supplementation, take the medication according to the original plan the next day.

Diet: Can be taken with food or on an empty stomach.

6. Dose adjustment

QTcF extension:

481-500ms: Reduce dosage (e.g. 53mg → 35.4mg).

500ms: Suspend administration and reduce dosage after recovery.

Adverse reactions: Non hematological grade 3/4 toxicity needs to be temporarily suspended or reduced.

Combination use of strong CYP3A4 inhibitors: dose halved (e.g. 53mg → 26.5mg).

7. Medication precautions

Electrocardiogram monitoring: Regularly monitor QT interval, blood potassium, and blood magnesium before and during medication.

Taboo combination drugs: Avoid combining with strong/medium acting CYP3A4 inducers (such as St. John's wort) or other QT prolonging drugs.

8. Medication for special populations

Pregnant women: May cause fetal malformation, effective contraception should be used until 7 months (female) or 4 months (male) after the last dose.

Breastfeeding period: Avoid breastfeeding during treatment and within one month of discontinuing medication.

Children: Safety has not been established.

Liver/kidney dysfunction: Mild to moderate without adjustment, severe without recommended dosage.

9. Adverse reactions

Common (≥ 20%): lymphopenia, hypokalemia, hypoalbuminemia, diarrhea, oral mucosal inflammation, nausea, abdominal pain, sepsis, headache.

Serious: QT prolongation (14%), apical torsion ventricular tachycardia (0.2%), cardiac arrest (0.6%).

10. Contraindications

History of severe hypokalemia, severe hypomagnesemia, long QT syndrome, ventricular arrhythmia, or apical torsion ventricular tachycardia.

11. Drug interactions

Strong CYP3A4 inhibitors (such as ketoconazole): need to be reduced.

QT prolonging drugs (such as moxifloxacin): increase monitoring frequency.

Hormonal contraceptive pills: may fail, non hormonal contraception should be used instead.

12. Storage method

Store at 20 ° C-25 ° C (15 ° C-30 ° C allowed), with the original bottle sealed to prevent moisture.

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