Big Bear ZAGUDX Quizartinib 17.7mg

Product Information

• Product name: ZAGUDX Quizartinib17 Quizartinib 17.7mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Quizartinib
• Current strength: 17.7mg
• SKU: Product ID 3144
• Site category: general medicines

Product Summary

ZAGUDX Quizartinib17 Quizartinib 17.7mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Quizartinib is the active ingredient used for this product page. Public prescribing information for Quizartinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Quizartinib is a small molecule inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation.

Reference Indications

Quizartinib 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 . Quizartinib is a kinase inhibitor 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.

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken recommended dosage of Quizartinib by phase of therapy . Take Quizartinib tablets orally once daily with or without food at approximately the same time each day.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST Quizartinib prolongs the QT interval in a dose- and concentration-related manner . Prior to Quizartinib administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECGs to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter . Torsades de pointes and cardiac arrest have occurred in patients receiving Quizartinib. Do not administer Quizartinib to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome . Do not initiate treatment with Quizartinib or escalate the Quizartinib dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms .

Common Adverse Reactions and Monitoring

Newly Diagnosed FLT3-ITD positive AML The safety of Quizartinib (35.4 mg orally once daily with chemotherapy, 26.5 mg to 53 mg orally once daily as maintenance) in adult patients with newly diagnosed FLT3-ITD positive AML is based on QuANTUM-First, a randomized, double-blind clinical trial of Quizartinib (n=265) or placebo (n=268) with chemotherapy . Among patients who received Quizartinib, 38% were exposed for 6 months or longer and 30% were exposed for greater than one year. On the Quizartinib plus chemotherapy arm, 65% and 44% of patients completed induction and consolidation therapy, respectively, compared to 65% and 34% of patients in the placebo plus chemotherapy arm.

Drug Interactions and Special Populations

Table 7: Effect of Other Drugs on Quizartinib Strong CYP3A Inhibitors Clinical Impact Quizartinib is a CYP3A substrate. Prevention or Management Reduce the dosage of Quizartinib . Strong or Moderate CYP3A Inducers Clinical Impact Concomitant use of Quizartinib with strong or moderate CYP3A inducers decreases quizartinib systemic exposure , which may reduce Quizartinib efficacy. Prevention or Management Avoid concomitant use of Quizartinib with strong or moderate CYP3A inducers . QT Interval Prolonging Drugs Clinical Impact Quizartinib prolongs the QT/QTc interval. Coadministration of Quizartinib with other drugs that prolong the QT interval may further increase the incidence of QT prolongation .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: VANFLYTA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.