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Quizartinib is an oral, selective small molecule tyrosine kinase inhibitor specifically targeted at patients with acute myeloid leukemia (AML) with FLT3 gene mutations.
Generic name :Quizartinib
Trade name :VANFLYTA®
English name :Quiza rtinibTablets
In combination with standard cytarabine and anthracycline induction chemotherapy and cytarabine consolidation chemotherapy, and as maintenance monotherapy after consolidation chemotherapy, it is used for adults with newly diagnosed FLT3 internal tandem duplication (ITD)-positive acute myeloid leukemia (AML). Confirmation of FLT3-ITD mutations requires an FDA-approved test.
Restriction : Not suitable for maintenance monotherapy after allogeneic hematopoietic stem cell transplantation (HSCT).
Specifications :
17.7 mg tablet: white round film-coated tablet, engraved with "DSC511".
26.5 mg tablet: yellow, round, film-coated tablet, engraved with "DSC512".
Characteristics : Film-coated tablets, the content is white to off-white powder.
Active ingredient : Quizartinib.
Excipients : Hydroxypropyl betacyclodextrin, microcrystalline cellulose, magnesium stearate; coating contains hypromellose, talc, triacetin, titanium dioxide (26.5mg tablets also contain iron oxide yellow).
Induction period : 35.4 mg orally, once a day (starting on the 8th day of chemotherapy and lasting for 14 days).
Consolidation phase : 35.4 mg orally, once a day (starting on the 6th day of chemotherapy and lasting for 14 days).
Maintenance period :Initially 26.5 mg once a day, if QTcF ≤ 450 ms, increase to 53 mg once a day on the 15th day.
If you miss a dose of : Take it within 12 hours; skip if it exceeds 12 hours, and take the medicine as originally planned the next day.
Vomiting : No need to take additional doses, just take the medicine as originally planned the next day.
Diet : Can be taken with food or on an empty stomach.
QTcF prolongation :
481-500ms: dose reduction (such as 53mg → 35.4mg).
500ms: Pause dosing and reduce dose after recovery.
Adverse reaction : Non-hematological grade 3/4 toxicity requires suspension or dose reduction.
Concomitant use of strong CYP3A4 inhibitor : Reduce the dose by half (eg 53mg→26.5mg).
Electrocardiogram monitoring :Monitor QT interval, serum potassium and serum magnesium regularly before and during medication.
Contraindicated concomitant use of : Avoid concomitant use with strong/moderate CYP3A4 inducers (such as St. John's wort) or other QT prolonging drugs.
Pregnant women : may cause fetal malformation, effective contraception is required until 7 months (females) or 4 months (men) after the last dose.
Lactation : Avoid breastfeeding during treatment and within 1 month of stopping the drug.
Children : Safety has not been established.
Hepatic/renal insufficiency : No adjustment is required for mild to moderate, and no recommended dose for severe.
Common (≥20%) : Lymphopenia, hypokalemia, hypoalbuminemia, diarrhea, oral mucositis, nausea, abdominal pain, sepsis, headache.
Severe : QT prolongation (14%), torsade de pointes (0.2%), cardiac arrest (0.6%).
A history of severe hypokalemia, severe hypomagnesemia, long QT syndrome, ventricular arrhythmia or torsade de pointes.
Strong CYP3A4 inhibitor (such as ketoconazole): Need to reduce the dose.
QT prolonging drugs (such as moxifloxacin): Increase monitoring frequency.
Hormonal contraceptive : may be ineffective and you need to switch to non-hormonal contraception.
Save at 20°C-25°C (15°C-30°C allowed), the original bottle is sealed to prevent moisture.