glasdegib

What is the most important information I should know about glasdegib?

What is glasdegib?

Glasdegib is used 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 use standard chemotherapy due to other medical conditions.

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

What should I discuss with my healthcare provider before taking glasdegib?

• If you are a woman who is able to get pregnant, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.
• If you are a man, use condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Keep using condoms for at least 30 days after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using glasdegib.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because glasdegib can harm an unborn baby.

Tell your doctor if you have ever had:

• heart problems;
• long QT syndrome (in you or a family member); or
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

How should I take glasdegib?

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, and cytarabine is given as an injection under your skin. Your doctor will determine how long to treat you with this medicine.

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

If you vomit shortly after taking glasdegib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

What happens if I miss a dose?

Take 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 at one time or use more than one dose in a 12-hour period.

What happens if I overdose?

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

What should I avoid while taking glasdegib?

You must not donate blood or sperm while you are using glasdegib, and for at least 30 days after your last dose. If donated blood containing glasdegib is given to a pregnant woman, it could cause birth defects.

What are the possible side effects of glasdegib?

• 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;
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
• low white blood cell counts --fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing.

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

Common side effects may include:

• bleeding, low platelet count;
• fever, low blood cell counts;
• mouth sores, changes in your sense of taste;
• 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.

What other drugs will affect glasdegib?

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

Other drugs may affect glasdegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about glasdegib.