Azacitidine

Azacitidine is a prescription medication used to treat myelodysplastic syndrome. The bone marrow does not make enough healthy blood cells in this type of condition. Azacitidine belongs to a group of drugs called demethylation agents, which work by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

This medication is available in an injectable form to be given directly under the skin (subQ) or into the vein (IV) by a healthcare professional.

Common side effects of azacitidine include nausea, vomiting, fever, and constipation.

Azacitidine is a prescription medication used to treat the following myelodysplastic syndrome (MDS) subtypes:

• Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS)
• Refractory anemia with excess blasts (RAEB)
• Refractory anemia with excess blasts in transformation (RAEB-T)
• Chronic myelomonocytic leukemia (CMMoL)

MDS is a group of conditions in which the bone marrow produces blood cells that are irregularly shaped. As a result, not enough healthy blood cells are made.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Azacitidine may be found in some form under the following brand names:

• Onureg

• Vidaza

Serious side effects have been reported with azacitidine. See the “Drug Precautions” section.

Common side effects of azacitidine include the following:

• nausea
• vomiting
• fever
• diarrhea
• redness or irritation at the site of injection
• constipation
• purple bruises on the skin (ecchymosis)
• pin-point sized dots on the skin (petechiae)
• chills or shivering
• weakness
• lowered levels of potassium in the blood (hypokalemia)

This is not a complete list of azacitidine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No azacitidine drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with azacitidine including the following:

• lowered blood counts. This is medically known as bone marrow suppression. Your doctor may monitor for bone marrow suppression, as it can lead to thrombocytopenia, anemia, and neutropenia.
  • thrombocytopenia. This is a condition in which your blood has a lower than normal number of blood cell fragments called platelets. Tell your healthcare provider right away if you have the following signs and symptoms of thrombocytopenia:
    • mild to serious bleeding
    • purple, brown, and red bruises (purpura)
    • small red or purple dots on your skin (petechiae)
    • prolonged bleeding, even from minor cuts
    • bleeding or oozing from the mouth or nose, especially nosebleeds or bleeding from brushing your teeth
    • abnormal vaginal bleeding (especially heavy menstrual flow)
    • blood in the urine or stool or bleeding from the rectum. Blood in the stool can appear as red blood or as a dark, tarry color. Taking iron supplements also can cause dark, tarry stools.
    • headaches and other neurological symptoms. These problems are very rare, but you should discuss them with your doctor.
  • anemia. This is a condition in which your blood has a lower than normal number of red blood cells. Tell your healthcare provider right away if you have the following signs and symptoms of anemia:
    • shortness of breath
    • dizziness
    • headache
    • coldness in the hands and feet
    • pale skin
    • chest pain
  • neutropenia. This is when there is an abnormally low number of white blood cells. These cells, which are called neutrophils, help the body fight infection. Those who develop neutropenia are more likely to have fevers and infections.
• a decline in kidney function. Toxicity from azacitidine may occur resulting in kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests. Tell your healthcare provider right away right away if you have any of the following symptoms of kidney dysfunction:
  • swelling of face, ankles, hands, or feet
  • fatigue
  • paleness of skin
  • decreased urination
  • shortness of breath
  • change in blood pressures
  • side effects as mentioned in this section or in the “Side Effects” section of this medication page

Do not take azacitidine if you:

• are allergic to azacitidine or to any of its ingredients
• are allergic to mannitol
• have advanced malignant liver tumors

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of azacitidine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking azacitidine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to azacitidine or to any of its ingredients
• are allergic to mannitol
• have advanced malignant liver tumors
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azacitidine falls into category D. It has been shown that use of azacitidine in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if azacitidine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using azacitidine.

Take azacitidine exactly as prescribed.

This medication is available in an injectable form to be given directly under the skin (subQ) or into the vein (IV) by a healthcare professional.

If you miss a dose, be sure to make a follow up appointment.

Take azacitidine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The azacitidine dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function
• your kidney function
• your weight

The recommended starting dose with azacitidine for the first treatment cycle for all patients is 75 mg/m² daily for 7 days to be given under the skin (subQ) or into the vein (IV).

Repeat cycles (7 days per cycle) every 4 weeks. After 2 cycles, the dose may be increased to 100 mg/m². You should be treated for a minimum of 4 to 6 cycles.

If azacitidine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• You should be treated for a minimum of 4 to 6 cycles. You may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit.