Onureg is a prescription medicine used for continued treatment of adults with acute myeloid leukemia (AML) who:

• had a first complete remission (CR) following intensive induction chemotherapy with or without recovery of your blood cell counts, and
• who are not able to complete intensive curative therapy.

It is not known if Onureg is safe and effective in children under 18 years of age.

Both men and women using Onureg should use effective birth control to prevent pregnancy. Azacitidine can harm an unborn baby if the mother or father is using this medicine.

Use Onureg exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Onureg tablets are 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.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

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

Your treatment schedule may be different. Your doctor will determine how long to treat you with azacitidine. Onureg tablets should not be used in place of Vidaza (azacitidine) injection. 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.

Store Onureg at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Keep the container tightly closed when not in use.

You should not use Onureg if you are allergic to azacitidine.

To make sure Onureg is safe for you, tell your doctor if you have:

• kidney disease; or

• liver disease.

Azacitidine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use Onureg 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.

Onureg 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.

You should not breastfeed while using Onureg. Also do not breastfeed for at least 1 week after your last dose of Onureg.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction to Onureg: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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 Onureg 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; or

• dizziness.

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.

Other drugs may interact with 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.