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How it is administered
Quizartinib is taken by mouth as a tablet, once daily at about the same time each day. It can be taken with or without food. The tablets should be swallowed whole and not cut, crushed, or chewed.
Quizartinib is supplied as film-coated tablets in strengths equivalent to 20 mg and 30 mg quizartinib dihydrochloride. The dosing schedule depends on the phase of treatment (induction, consolidation, or maintenance) and is usually combined with other chemotherapy agents during the initial phases.
How it works
Quizartinib is a targeted therapy known as a kinase inhibitor. It works by blocking the activity of a protein called FLT3, which is a receptor tyrosine kinase. In some patients with acute myeloid leukemia (AML), a mutation called FLT3-ITD causes the FLT3 protein to be overactive, leading to the uncontrolled growth of leukemia cells.
Quizartinib and its active metabolite (AC886) bind to the ATP-binding domain of FLT3 and prevent its activation (autophosphorylation). This blocks the downstream signaling pathways that promote the survival and proliferation of leukemia cells with the FLT3-ITD mutation. By inhibiting this pathway, quizartinib helps to slow or stop the growth of cancerous cells in the bone marrow.
Common side effects
- Decreased lymphocytes (a type of white blood cell)
- Decreased potassium, magnesium, phosphorus, calcium, and albumin
- 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 (elevated liver enzymes)
- Thrombocytopenia (low platelets)
- Decreased appetite
- Fungal and herpesvirus infections
- Insomnia
- Prolonged QT interval on ECG (heart rhythm change)
- Eye irritation
Serious but less common side effects include torsades de pointes, cardiac arrest, and sudden death.
Who Should take it
Quizartinib is indicated for adult patients with newly diagnosed acute myeloid leukemia (AML) that is positive for the FLT3 internal tandem duplication (ITD) mutation. This medication is used in combination with standard chemotherapy (cytarabine and an anthracycline) during induction and consolidation phases, and as a single agent during maintenance therapy after consolidation chemotherapy.
It is important that patients are tested for the FLT3-ITD mutation using an FDA-approved test before starting quizartinib, as it is only effective in those whose leukemia cells carry this specific mutation.
Who should not take it
Quizartinib should not be taken by patients who have severe hypokalemia (very low potassium), severe hypomagnesemia (very low magnesium), long QT syndrome, or a history of ventricular arrhythmias or torsades de pointes. These conditions increase the risk of serious heart rhythm problems, which can be life-threatening.
Additionally, quizartinib is not recommended as maintenance therapy after allogeneic stem cell transplantation, as it has not been shown to improve survival in this setting. Women who are pregnant or may become pregnant should not take quizartinib due to the risk of harm to the unborn baby.
Commonly used with
Quizartinib is commonly used in combination with standard chemotherapy drugs for AML, specifically cytarabine and an anthracycline (such as daunorubicin or idarubicin) during induction and consolidation phases. After these phases, it may be used alone as maintenance therapy.
It is important to monitor for drug interactions, especially with medications that can prolong the QT interval or affect quizartinib metabolism.
Commonly tested with
Quizartinib has been tested in clinical trials in combination with standard AML chemotherapy regimens, including cytarabine and anthracyclines (daunorubicin or idarubicin). It has also been evaluated as a maintenance therapy after consolidation chemotherapy.
Patients are selected for quizartinib therapy based on the presence of the FLT3-ITD mutation, detected by an FDA-approved test.