【Drug Name】

Name: Gilteritinib Tablets

Product Name: GILLIDX

【Specification】

40mg

【Indications】

GILLIDX is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation when the disease has come back or has not improved after previous treatment(s).

Your healthcare provider will perform a test to make sure GILLIDX is right for you.

It is not known if GILLIDX is safe and effective in children. 

【Recommended Dosage】

Take GILLIDX exactly as your healthcare provider tells you.

• Do not change your dose or stop taking GILLIDX unless your healthcare provider tells you to.

• Take GILLIDX 1 time a day at about the same time each day.

• Swallow GILLIDX tablets whole with a cup of water.

• GILLIDX can be taken with or without food.

• Do not break, crush or chew GILLIDX tablets.

• If you miss a dose of GILLIDX, take your dose as soon as possible on the same day at least 12 hours before your next scheduled dose. Return to your normal schedule the following day. Do not take 2 doses within 12 hours. 

【Side Effects】

• Posterior Reversible Encephalopathy Syndrome (PRES). If you take GILLIDX, 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 GILLIDX if you develop PRES.

• Heart rhythm problems (QT prolongation). GILLIDX may 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 GILLIDX and during your treatment with GILLIDX. 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 GILLIDX.

• 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 most common side effects of GILLIDX include:

• joint or muscle pain

• changes in liver function tests

• fatigue

• fever

• swelling due to fluid retention

• rash

• nausea

• mouth sores

• infection that has spread through your body (sepsis)

• headache

• low blood pressure

• diarrhea

• shortness of breath

• pneumonia

• cough

• dizziness

• vomiting

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking GILLIDX if you develop certain side effects during treatment with GILLIDX. These are not all of the possible side effects of GILLIDX.

Call your doctor for medical advice about side effects. .

【Storage】

• GILLIDX comes in a child-resistant package.

• Store GILLIDX at room temperature between 68°F to 77°F (20°C to 25°C).

• Keep GILLIDX in the original container.

Keep CAMPAMDX and all medicines out of the reach of children.