GiltedX (Gilteritinib)40mg

Generic Name: Gilteritinib

Brand Names: GiltedX (Gilteritinib)40mg

Dosage form: 40mg x 84Tablets

Indications and Usage

Gilteritinib is a 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.

Side effects needing medical attention

Joint or muscle pain, changes in liver function tests, fatigue, fever, diarrhea, shortness of breath, swelling due to fluid retention, rash, nausea, mouth sores, pneumonia, cough, infection that has spread through your body (sepsis), headache, low blood pressure, dizziness, vomiting.

Gilteritinib may cause serious side effects, including:

• Posterior Reversible Encephalopathy Syndrome (PRES). If you take gilteritinib, you may be at risk of developing a condition involving the brain called PRES. Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your healthcare provider will do a test to check for PRES. Your healthcare provider will stop gilteritinibif you develop PRES.
• Heart rhythm problems (QT prolongation). gilteritinibmay cause a heart problem called QT prolongation. Your healthcare provider should check the electrical activity of your heart with a test called electrocardiogram (ECG) before you start taking gilteritiniband during your treatment with gilteritinib. Tell your healthcare provider right away if you have a change in your heartbeat, or if you feel dizzy, lightheaded, or faint. The risk of QT prolongation is higher in people with low blood magnesium or low blood potassium levels. Your healthcare provider will do blood tests to check your potassium and magnesium levels before and during your treatment with gilteritinib.
• 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.

Administration

Oral Administration

Administer with or without food

Swallow whole; do not break or crush

Administer at same time each day

Missed dose

• Administer as soon as possible on the same day, and at least 12 hr prior to next scheduled dose; resume normal schedule the following day
• Do not administer 2 doses within 12 hr

Storage

Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

Keep in original container