Glasdegib

Glasdegib is used in adults along with cytarabine to treat acute myeloid leukemia. This combination is for adults who are 75 years or older, or who cannot have chemotherapy because of other medical issues.

Glasdegib may also be used for reasons not mentioned in this medication guide.

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.

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.

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.

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 right away 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 stopped 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.

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 responseUse: 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 responseUse: 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

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.

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.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may lead to more side effects or make the medicines work less well.

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

Other drugs can affect glasdegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.