Vidaza is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

Vidaza is supplied as lyophilized powder in 100 mg single-dose injection vials.

Both men and women using Vidaza 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 receive Vidaza if you have advanced liver cancer.

Azacitidine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

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

Vidaza injection 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 injection 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 Vidaza. Onureg (azacitidine) tablets should not be used in place of Vidaza 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. Your cancer treatments may be delayed based on the results.

Store Vidaza injection at 25º C (77º F); excursions are permitted to 15º-30º C (59º-86º F).

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

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 Vidaza if you are allergic to azacitidine.

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

To make sure this medicine 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 Vidaza if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine.

• If you are a man, use effective birth control if your sex partner is able to get pregnant.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is 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 Vidaza.

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.

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 Vidaza: 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 Vidaza 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.

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.