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Overview: Onureg is used to treat acute myeloid leukemia. Common side effects include nausea and vomiting, diarrhea, tiredness, and constipation. Serious side effects may include low levels of certain types of blood cells. Onureg is a tablet that you take by mouth.

Uses

What is Onureg used for?

Onureg (azacitidine) is commonly used to treat certain people with acute myeloid leukemia (AML), which is a type of blood cancer. 

Onureg may also be used for other conditions as determined by your health care provider.

Azacitidine is also available in an injectable form that is used for other conditions. See Azacitidine (Vidaza) for more information. 

How does Onureg work (mechanism of action)?

Onureg is chemotherapy and contains the medicine azacitidine. Azacitidine works by entering cancer cells and becoming a part of their DNA and RNA. This may help slow or stop the growth of cancer cells. 

How is Onureg supplied (dosage forms)?

Brands and other names

  • Azacitidine 
  • Onureg
  • Vidaza

Dosage forms and strengths

  • 200 mg oral tablets
  • 300 mg oral tablets

How should I store Onureg?

Onureg should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. 

Keep Onureg in its original packaging. It may come in a bottle or in blister packs. If you receive Onureg in a bottle, keep the bottle tightly closed. There will be drying agent canisters (desiccants) in the bottle. Keep these desiccants in the bottle to help keep the medicine dry. Do not eat the desiccants. If you receive Onureg in blister packs, keep the medicine in the blister pack until you are ready to take it.

Side Effects

What are the most common side effects of Onureg?

The most common side effects of Onureg are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea and vomiting
  • Diarrhea
  • Tiredness or weakness
  • Constipation
  • Pneumonia, which is a lung infection
  • Stomach pain
  • Joint pain
  • Decreased appetite
  • Blood disorders (see below)
  • Dizziness
  • Pain in the arms or legs

There may be other side effects of Onureg that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Onureg?

While less common, the most serious side effects of Onureg are described below, along with what to do if they happen.

Severe Allergic Reactions. Onureg may cause allergic reactions, which can be serious. Stop taking Onureg and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Disorders. Onureg can cause blood disorders, such as low platelet levels (thrombocytopenia) and low neutrophil levels (neutropenia). These are common side effects of Onureg, but they can sometimes be severe. Having a low level of neutrophils may increase your risk of infection. It is important to go to all appointments for blood work before and while taking Onureg to make sure it is safe for you. Get help right away if you have any of the following symptoms of blood disorders.

  • Fever, chills, or body aches
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Unusual headaches
  • Fast or abnormal heartbeat

Warnings & Precautions

Who should not use Onureg?

Allergies to Ingredients. People who are allergic to any of the following should not take Onureg.

  • Azacitidine
  • Onureg
  • Vidaza
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Onureg.

What should I know about Onureg before using it?

Do not take Onureg unless it has been prescribed to you by a health care provider.

Do not share Onureg with other people, even if they have the same condition as you. It may harm them.

Keep Onureg out of the reach of children.

Your health care provider may prescribe other medicines to prevent nausea, vomiting, or diarrhea while you are taking Onureg. Take these medicines exactly as your health care provider tells you to. 

Onureg tablets should be swallowed whole and should not be crushed, cut, or chewed. If powder from the tablets comes into contact with your skin, eyes, or mouth, wash or flush the area well right away.

Onureg may make it hard for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Onureg?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Onureg is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Pregnancy. Onureg may cause harm to an unborn baby. Your health care provider will likely make sure you are not pregnant before starting Onureg. If you can become pregnant, you should use effective birth control while taking Onureg and for at least six months after your last dose. If you are able to get a partner pregnant, you should use effective birth control while taking Onureg and for at least three months after your last dose. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Onureg passes into breast milk. Do not breastfeed while taking Onureg and for at least one week after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

Vaccines. Talk with your health care provider about any vaccines that you may need. You may not be able to receive certain vaccines right before or while taking Onureg. Tell your health care provider about any vaccines you have recently received or have scheduled.

How can I get more information about Onureg?

For more information about Onureg, you can visit the drugmaker’s website at www.onureg.com or call them at 800-721-5072.

Interactions

Does Onureg interact with foods or drinks?

There are no known interactions between Onureg and foods or drinks.

It is unknown if drinking alcohol will affect Onureg, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. 

Does Onureg interact with other medicines (drug interactions)?

There are no known interactions between Onureg and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Onureg?

If you or someone else has used too much Onureg, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Onureg?

If you miss a dose or do not take it at the usual time, take it as soon as you remember on the same day. Then take your next dose at the usual time the next day. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

If you vomit after taking Onureg, do not repeat that dose or take an extra dose. Instead, take your next dose at the usual time the next day.