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How it is administered
Quizartinib is taken by mouth as a film-coated tablet. It should be swallowed whole, not cut, crushed, or chewed. The medication is usually taken once daily at about the same time each day, with or without food. The specific dosing regimen depends on the phase of therapy (induction, consolidation, or maintenance) and is determined by your healthcare provider. If a dose is missed, it should be taken as soon as possible on the same day, but two doses should not be taken on the same day. If a dose is vomited, do not take an extra dose; wait until the next scheduled dose.
Quizartinib is supplied in tablets containing 17.7 mg or 26.5 mg of the active ingredient, which are equivalent to 20 mg and 30 mg of quizartinib dihydrochloride, respectively.
How it works
Quizartinib is a type of targeted therapy known as a kinase inhibitor. It works by blocking the activity of a protein called FLT3, which is found on the surface of certain leukemia cells. In some patients with acute myeloid leukemia (AML), a mutation called FLT3-ITD causes this protein to be overactive, leading to the uncontrolled growth of leukemia cells.
By inhibiting FLT3, quizartinib prevents the leukemia cells from receiving signals that tell them to grow and divide. This helps slow down or stop the progression of the disease. Quizartinib and its active metabolite (AC886) specifically bind to the ATP-binding domain of FLT3, blocking its kinase activity and downstream signaling pathways that promote cell survival and proliferation. This targeted action makes quizartinib especially useful for patients whose AML tests positive for the FLT3-ITD mutation.
Common side effects
- Decreased lymphocytes (a type of white blood cell)
- Low potassium, magnesium, phosphorus, calcium, and albumin levels
- Increased alkaline phosphatase (a liver enzyme)
- Febrile neutropenia (fever with low white blood cell count)
- Diarrhea
- Mucositis (mouth and throat sores)
- Nausea and vomiting
- Abdominal pain
- Sepsis (serious infection)
- Neutropenia (low neutrophil count)
- Headache
- Increased creatine phosphokinase (muscle enzyme)
- Upper respiratory tract infection
- Hypertransaminasemia (increased liver enzymes)
- Thrombocytopenia (low platelets)
- Decreased appetite
- Fungal and herpesvirus infections
- Insomnia
- Prolonged QT interval on ECG
- Eye irritation
Serious heart rhythm problems, including QT prolongation, torsades de pointes, and cardiac arrest, have also been reported.
Who Should take it
Quizartinib is indicated for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as determined by an FDA-approved test. It is used in combination with standard chemotherapy (cytarabine and anthracycline) during induction and consolidation phases, and as maintenance therapy following consolidation chemotherapy.
Quizartinib is not intended for use as maintenance therapy after a stem cell transplant, as its benefit in that setting has not been demonstrated. Your doctor will determine if quizartinib is appropriate for you based on the genetic testing of your leukemia cells and your overall treatment plan.
Who should not take it
Quizartinib should not be taken by patients who have severe low potassium (hypokalemia), severe low magnesium (hypomagnesemia), long QT syndrome, or a history of certain serious heart rhythm problems (such as ventricular arrhythmias or torsades de pointes). It should also not be started if your electrocardiogram (ECG) shows a QTc interval greater than 450 ms.
Patients with significant heart disease, recent heart attack, uncontrolled high blood pressure, or other conditions that increase the risk of abnormal heart rhythms should avoid quizartinib. Pregnant women should not take quizartinib due to the risk of harm to the unborn baby. Women who are breastfeeding should also avoid this medication.
Commonly used with
Quizartinib is commonly used in combination with standard chemotherapy agents for AML, specifically cytarabine and an anthracycline (such as daunorubicin or idarubicin) during the induction and consolidation phases. It is also used as a single agent (monotherapy) during the maintenance phase after chemotherapy.
Your healthcare provider may adjust other medications to avoid interactions, especially those that can affect heart rhythm or the way quizartinib is metabolized.
Commonly tested with
Quizartinib has been tested in clinical trials with standard AML chemotherapy regimens, including cytarabine and anthracyclines (daunorubicin or idarubicin). It has also been evaluated as maintenance therapy following consolidation chemotherapy.
Drug interaction studies have evaluated quizartinib with medications that affect the CYP3A enzyme system, such as ketoconazole (a strong CYP3A inhibitor) and efavirenz (a CYP3A inducer), as well as with drugs that can prolong the QT interval.
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