Azacitidine (ay-za-SYE-ti-deen)

Treats acute myeloid leukemia (AML).

Brand Name(s):

Onureg

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 at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• You may also receive medicines to help prevent nausea and vomiting at least 30 minutes before each dose of this medicine.
• If the powder from the tablet comes in contact with your skin, wash the area right away with soap and water. If it comes in contact with your eyes or mouth, rinse the area right away with water.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, do not take an extra dose on the same day. Go back to your regular dosing schedule the next day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store this medicine in its original container.

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 azacitidine works. Tell your doctor if you are also using omeprazole.

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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or bone marrow problem.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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 could cause infertility. Talk with your doctor before using this medicine if you plan 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
• Chest pain, trouble breathing
• Fever, chills, body aches, unusual headaches
• Unusual bleeding, bruising, severe tiredness, severe weakness

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

• Constipation, diarrhea, decreased appetite, nausea, vomiting, stomach pain
• Dizziness
• Joint, arm, or leg pain

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