What is Gilteritinib 40mg Tablets?

Gilteritinib 40mg Tablets is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with an 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 Gilteritinib 40mg Tablets are right for you. It is not known if Gilteritinib 40mg Tablets is safe and effective in children.

What is the most important information I should know about Gilteritinib 40mg Tablets?

Differentiation Syndrome is one of the major negative effects that Gilteritinib 40mg Tablets may cause. Blood cell disorders such as Differentiation Syndrome can be fatal or life-threatening if left untreated. During the first three months of treatment, and even as soon as one day after commencing Gilteritinib 40mg Tablets, Differentiation Syndrome can occur. If you experience any of the following differentiation syndrome symptoms while taking Gilteritinib 40mg Tablets: fever, cough, dizziness or lightheadedness, rapid weight gain, difficulty breathing, swelling of your arms or legs, rash, decreased urination, call your healthcare provider or head straight to the nearest hospital emergency room. If you experience any of these differentiation syndrome symptoms, your doctor may prescribe a corticosteroid medication as well as monitor you in the hospital.

Who should not take Gilteritinib 40mg Tablets?

Do not take Gilteritinib 40mg Tablets if you are allergic to Gilteritinib or any of the ingredients in Gilteritinib 40mg Tablets.

What are the possible side effects of Gilteritinib 40mg Tablets?

Gilteritinib 40mg Tablets may cause serious side effects including:

See “What is the most important information I should know about Gilteritinib 40mg Tablets?” above.

Syndrome of Posterior Reversible Encephalopathy (PRES). If you use Gilteritinib 40mg Tablets, you can run the risk of getting PRES, a brain disorder. If you experience a seizure or rapidly worsening symptoms like headache, decreased alertness, disorientation, diminished vision, blurred vision, or other visual issues, notify your healthcare professional straight away. To screen for PRES, your healthcare professional will do a test. If you get PRES, your doctor will discontinue giving you Gilteritinib 40mg Tablets.

QTc prolongation is the term for alterations in your heart’s electrical activity. Life-threatening irregular heartbeats can result from QTc prolongation. Both before and throughout your Gilteritinib 40mg Tablet treatment, your healthcare practitioner will perform an electrocardiogram (ECG) to measure the electrical activity of your heart. If you experience fainting, dizziness, or lightheadedness, notify your healthcare professional right away. Low levels of potassium or magnesium in the blood increase the risk of QT prolongation. Blood tests will be performed by your healthcare practitioner to measure your magnesium and potassium levels both before and throughout Gilteritinib 40mg Tablet treatment.

pancreatitis, or inflammation of the pancreas. If you experience severe stomach pain that does not go away, you should notify your healthcare professional straight away. This pain may occur in the presence or absence of nausea and vomiting.

The most common side effects of Gilteritinib 40mg Tablets include:

Changes in liver function tests

Joint or muscle pain

Tiredness

Fever

Pain or sores in mouth or throat

Swelling of arms or legs

Rash

Diarrhea

Shortness of breath

Nausea

Cough

Constipation

Eye problems

Headache

Dizziness

Low blood pressure

Vomiting

Decreased urination

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking Gilteritinib 40mg Tablets if you develop certain side effects during treatment with Gilteritinib 40mg Tablets.

These are not all of the possible side effects of Gilteritinib 40mg Tablets. Call your doctor for medical advice about side effects.

What should I tell my doctor before taking Gilteritinib 40mg Tablets?

Tell your doctor:

About all of your medical conditions.

If you suffer from cardiac issues, such as long QT syndrome.

If you experience issues with abnormal levels of sodium, potassium, or magnesium in your body.

If you are or intend to get pregnant. Gilteritinib 40mg Tablets may be harmful to the developing fetus. If you become pregnant while taking Gilteritinib 40mg Tablets or suspect you might be pregnant, notify your doctor at away.

If you can become pregnant, your healthcare provider may perform a pregnancy test 7 days before you start treatment with Gilteritinib 40mg Tablets.

Females who can become pregnant should use effective birth control (contraception) during treatment with Gilteritinib 40mg Tablets and for 6 months after the last dose of Gilteritinib 40mg Tablets.

Males who have female partners who can become pregnant should use effective birth control (contraception) during treatment with Gilteritinib 40mg Tablets and for 4 months after the last dose of Gilteritinib 40mg Tablets.

If you are breastfeeding or plan to breastfeed. It is not known if Gilteritinib 40mg Tablets pass into your breast milk. Do not breastfeed during treatment with Gilteritinib 40mg Tablets and for 2 months after the last dose of Gilteritinib 40mg Tablets.

nearly every medication you take, including vitamins, herbal supplements, and both prescription and over-the-counter medications. The effects of other medications on Gilteritinib 40mg Tablets and the effects of other medications on Gilteritinib 40mg Tablets may coexist.

How should I take Gilteritinib 40mg Tablets?

Take Gilteritinib 40mg Tablets exactly as your healthcare provider tells you.

Do not change your dose or stop taking Gilteritinib 40mg Tablets unless your healthcare provider tells you to.

Take Gilteritinib 40mg Tablets 1 time a day at about the same time each day.

Swallow Gilteritinib 40mg Tablets tablets whole.

Gilteritinib 40mg Tablets can be taken with or without food.

Do not break, crush, or chew Gilteritinib 40mg Tablets tablets.

If you miss a dose of Gilteritinib 40mg Tablets, take your dose as soon as possible on the same day at least 12 hours before your next scheduled dose. Start your routine again the next day. Never take two doses in 12 hours.