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.

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

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

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.

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.

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.

If any Vidaza accidentally gets on your skin, wash it thoroughly with soap and warm water.

Your treatment schedule may be different. Your doctor will determine how long to treat you with azacitidine. 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.

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.

Usual Adult Dose for Myelodysplastic Syndrome:

FIRST TREATMENT CYCLE: 75 mg/m2 IV or subcutaneously daily for 7 days; repeat cycles every 4 weeks
SUBSEQUENT CYCLES: After 2 cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and if no toxicity other than nausea and vomiting has occurred
DURATION OF THERAPY: Minimum of 4 to 6 cycles; may continue treatment if the patient continues to benefit

Comments:
-Premedicate patients for nausea and vomiting.

Use: Treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB); refractory anemia with excess blasts in transformation (RAEB-T); and chronic myelomonocytic leukemia (CMMoL)

Usual Adult Dose for Acute Myeloid Leukemia:

FIRST TREATMENT CYCLE: 75 mg/m2 IV or subcutaneously daily for 7 days; repeat cycles every 4 weeks
SUBSEQUENT CYCLES: After 2 cycles, may increase dose to 100 mg/m2 if no beneficial effect is seen and if no toxicity other than nausea and vomiting has occurred
DURATION OF THERAPY: Minimum of 4 to 6 cycles; may continue treatment if the patient continues to benefit

Comments:
-Premedicate patients for nausea and vomiting.

Use: Treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB); refractory anemia with excess blasts in transformation (RAEB-T); and chronic myelomonocytic leukemia (CMMoL)

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

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.

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 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.

You should not breastfeed while using azacitidine. 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.

Call your doctor for instructions if you miss an appointment for your Vidaza injection.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep the two desiccant (drying agent) canisters in the bottle of medication to keep the tablets dry. Do not eat the desiccant canisters.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Azacitidine may cause serious side effects. 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 side effects of azacitidine 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to azacitidine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.