Glasdegib is used in adults in combination with cytarabine to treat acute myeloid leukemia. This combination is for use in adults who are 75 years or older, or who cannot receive chemotherapy due to other medical conditions.

Glasdegib may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Use effective birth control. Both men and women using glasdegib should use effective birth control to prevent pregnancy. Glasdegib can harm an unborn baby if the mother or father is using this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Glasdegib is given in a 28-day treatment cycle, usually for a total of 6 cycles. Glasdegib is taken by mouth. Your doctor will determine how long to treat you with glasdegib.

Take the medicine once a day at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking glasdegib, do not take another dose. Take your next dose as scheduled.

Your heart function may need to be checked using an electrocardiogram or ECG (sometimes called an EKG).

You will need frequent medical tests and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Acute Myeloid Leukemia:

100 mg orally once a day on days 1 to 28 in combination with cytarabine 20 mg subcutaneously 2 times a day on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control; for patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response

Use: This drug, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy

Usual Geriatric Dose for Acute Myeloid Leukemia:

75 years or older:
100 mg orally once a day on days 1 to 28 in combination with cytarabine 20 mg subcutaneously 2 times a day on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control; for patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response

Use: This drug, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy

Tell your doctor if you have ever had:

• heart problems;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• muscle pain or muscle spasms;

• kidney disease; or

• liver disease.

You will need to take a pregnancy test within 7 days of starting treatment with glasdegib.

May harm an unborn baby. You will need a pregnancy test to make sure you are not pregnant. Use effective birth control while using glasdegib and for at least 30 days after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 30 days after your last dose.

Men using glasdegib should use condoms during treatment, even after a vasectomy and for at least 30 days after treatment ends.

It may be harder for you to get a woman pregnant while you are using this medicine.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses within 12 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tiredness, nausea, vomiting, dizziness, feeling like you might pass out, thirst, and little or no urination.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not donate blood while taking glasdegib, and for at least 30 days following your last dose.

Do not donate semen while you are taking glasdegib, and for at least 30 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Glasdegib may cause serious side effects. Call your doctor at once if you have:

• irregular or fast heartbeats, shortness of breath, and sudden dizziness (like you might pass out);

• easy bruising, unusual bleeding, purple or red spots under your skin;

• any new or worsening muscle pain or muscle spasms; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of glasdegib may include:

• bleeding;

• fever, low blood cell counts;

• changes in your sense of taste;

• pain or sores in mouth or throat;

• loss of appetite, constipation, nausea;

• rash;

• muscle pain;

• swelling in your arms or legs;

• feeling tired; or

• trouble breathing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Glasdegib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect glasdegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests such as electrocardiograms (EKG, test that records the electrical activity of the heart) and blood tests before and during therapy to make sure it is safe for you to take glasdegib and to check your body's response to the medication.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.