Class: Chemotherapy
Generic Name : Azacitidine
Trade Name: Onureg®

For which conditions is Onureg approved for? Onureg is approved for the 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.

What is the mechanism of action? Onureg belongs to a group of drugs called a nucleoside analogue. Onureg produces its anti-cancer effects by inhibiting the ability of DNA replication. The suppression of DNA replication tends to affect faster replicating cells, such as cancer cells, ultimately causing cellular death.

How is Onureg typically given (administered)? Onureg is taken orally one time each day with or without food at about the same time each day. Onureg tablets should be taken whole.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Onureg. Typically, blood may be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Physical examinations, scans, or other measures may also be utilized to assess side effects and response to therapy.

What are the common side effects of treatment with Onureg?

  • Nausea and vomiting
  • Diarrhea
  • Fatigue/weakness
  • Constipation
  • Stomach area pain
  • Pneumonia
  • Joint pain
  • Decreased appetite
  • Pain in arms or legs
  • Dizziness

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting chemotherapy?

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  • Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment and for 3 months (male) or 6 months (female) after your last treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
  • Do not breastfeed during treatment or for 1 week after the last dose of Onureg.
  • It is important that patients inform their physician of any pre-existing conditions (kidney or liver problemsas they may worsen with this drug.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should check with their physician before starting any new drug or nutritional supplement.
  • Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
  • If the powder from Onureg tables comes in contact with your skin, eyes or mouth, flush the area right away.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your healthcare provider right away if you experience symptoms of:

  • Low white blood cell counts: fever, chills, body aches, feeling very tired or weak, unusual headaches.
  • Low platelet counts: unusual bruising or bleeding.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 4/21.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.