Glasdegib (glas-DEG-ib)

Treats acute myeloid leukemia.

Brand Name(s):

Daurismo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine with or without food at about the same time each day. Swallow the tablet whole. Do not break, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is less than 12 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses of this medicine within 12 hours. If you vomit after you take a dose, do not take an extra dose. Just take your next dose at your regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how glasdegib works. Tell your doctor if you are also using efavirenz, ketoconazole, rabeprazole, or rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 30 days after the last dose. Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant. Male patients with female partners should use an effective form of birth control (even after a vasectomy) during treatment and for 30 days after the last dose.
• Do not breastfeed during treatment and for at least 30 days after the last dose.
• Do not donate blood or blood products or sperm while you are using this medicine and for at least 30 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart failure, electrolyte imbalance, or a history of heart or blood vessel disease or heart rhythm problems (including long QT syndrome).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause heart rhythm problems.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat
• Lightheadedness, dizziness, or fainting

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach pain
• Headache
• Nausea, vomiting, decreased appetite

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088