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Gilteritinib is available as a 40 mg oral tablet.

Gilteritinib is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

Gilteritinib works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

Gilteritinib is typically given as 120 mg by mouth once daily.

Gilteritinib is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Gilteritinib:

• Increased transaminase
• Joint/muscle pain
• Fatigue/malaise
• Fever
• Edema
• Rash
• Diarrhea
• Shortness of breath
• Nausea
• Cough
• Constipation
• Headache
• Dizziness
• Vomiting
• Low blood pressure

Serious side effects are rare with Gilteritinib. Contact your doctor right away if you experience:

• Posterior Reversible Encephalopathy Syndrome (PRES): Seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision, or other visual problems
• QTc prolongation: Can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
• Inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you have severe stomach (abdomen) pain that does not go away. This pain may happen with or without nausea and vomiting

The following medications may interact with Gilteritinib:

• Combined P-gp and Strong CYP3A Inducers: Avoid concomitant use
• Strong CYP3A Inhibitors: Consider alternative therapies. If the concomitant use of strong CYP3A inhibitors cannot be avoided, monitor patients more frequently for Gilteritinib adverse reactions
• P-gp, BCRP, OCT1 Substrates: Decrease the dose of the substrates when coadministered with Gilteritinib and as clinically indicated

Various FDA-approved generic manufacturers

Gilteritinib can cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Gilteritinib. If you are able to become pregnant, your healthcare provider may perform a pregnancy test 7 days before you start treatment with Gilteritinib. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Gilteritinib and for 6 months after the last dose of Gilteritinib. Males who have female partners that are able to become pregnant should use effective birth control
(contraception) during treatment with Gilteritinib and for 4 months after the last dose of Gilteritinib.

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