azacitidine (oral/injection)

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

What is azacitidine?

Azacitidine oral is used to treat acute myeloid leukemia in people who are in remission but cannot finish other treatments for this condition.

Azacitidine injection is used to treat certain types of bone marrow cancers and blood cell disorders.

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

What should I discuss with my healthcare provider before using azacitidine?

You should not be treated with azacitidine injection if you are allergic to mannitol, or if you have advanced liver cancer.

Tell your doctor if you have ever had:

• kidney disease; or
• liver disease.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use azacitidine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine. If you take Onureg, keep using birth control for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. If you take Onureg, keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Onureg or using Vidaza.

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

How should I use azacitidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Azacitidine oral (Onureg) is taken by mouth in a 28-day treatment cycle. You may need to take the medicine only during the first 2 weeks of each cycle.

Take Onureg 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 Onureg, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Azacitidine injection (Vidaza) is injected under the skin, or given as an infusion into a vein. A healthcare provider will give you this injection, usually for 7 days in a row every 4 weeks for at least 4 treatment cycles.

Your treatment schedule may be different. Your doctor will determine how long to treat you with this medicine. Onureg should not be used in place of Vidaza. The oral and injection forms of this medicine have different uses and dosages.

You may also be given medicine to reduce nausea and vomiting. Use this medicine only as prescribed.

Azacitidine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney function may also need to be tested. Your cancer treatments may be delayed based on the results.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while using azacitidine?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of azacitidine?

• severe ongoing nausea, vomiting, or diarrhea;
• redness, swelling, warmth, oozing, or other signs of skin infection;
• 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;
• signs of a lung infection --fever, cough with mucus, chest pain, feeling short of breath;
• kidney problems --pain in your lower back, blood in your urine, little or no urination, swelling in your feet or ankles;
• liver problems --upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of tumor cell breakdown --tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

• fever, chills, bruising, or other signs of low blood cell counts;
• lung infection;
• low potassium;
• nausea, vomiting, stomach pain, loss of appetite;
• constipation, diarrhea;
• joint pain, pain in your arms or legs;
• feeling weak or tired;
• dizziness; or
• redness where an injection was given.

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 azacitidine?

Other drugs may affect azacitidine, 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 doctor or pharmacist can provide more information about azacitidine.