Onureg (azacitidine)

What is Onureg?

Onureg is a brand-name prescription medication. It’s used for continued treatment of acute myeloid leukemia (AML) in certain situations.

AML is a type of cancer that causes your white blood cells to grow abnormally or make too many of themselves. AML can occur in your blood or bone marrow.

Specifically, Onureg is used to continue AML treatment in adults who had complete remission after using chemotherapy as the first treatment for their AML. With complete remission, your symptoms of cancer disappear. Onureg can be used whether or not your blood cell counts improved after initial treatment with chemotherapy.

However, Onureg can only be used if you can’t continue treatment with an intensive curative therapy for AML. An intensive curative therapy includes both high-dose chemotherapy and a stem cell transplant.

For information about how Onureg is used, see the “Onureg for AML” section below.

Drug details

Onureg comes as tablets that are taken by mouth. It’s available in two strengths: 200 milligrams (mg) and 300 mg. These tablets come in both bottles and blister cards.

The active drug in Onureg is azacitidine. It belongs to a group of medications called nucleoside metabolic blockers.

Onureg hasn’t been studied in children. So it’s not known if the drug is a safe or effective treatment option for children.

Orphan drug status

Onureg is an “orphan drug.” This means it was given a special status by the Food and Drug Administration (FDA) when they approved it in 2004.

A medication may be given orphan drug status by the FDA if the drug treats a rare disease. With orphan drug status, the manufacturer of the drug may receive tax credits to help with the cost of their clinical trials.

This status is awarded to encourage drug companies to continue researching treatments for rare diseases. And this is helpful because drugs for rare diseases may not produce as much profit as drugs for more common diseases.

Effectiveness

For information about the effectiveness of Onureg, see the “Onureg for AML” section below.

Onureg generic

Onureg contains the active drug azacitidine. It’s available only as a brand-name medication. Azacitidine is not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Onureg for AML

The Food and Drug Administration (FDA) approves prescription drugs such as Onureg to treat certain conditions. Onureg may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Onureg is used for continued treatment of acute myeloid leukemia (AML) in certain situations.

About AML

AML is a type of cancer that causes your white blood cells to grow abnormally or make too many of themselves. AML can occur in your blood or bone marrow.

Symptoms of AML may include:

• bleeding easier than usual, such as getting nosebleeds or bleeding gums
• bruising easier than usual
• bone pain
• trouble breathing
• weight loss that’s not intentional

How Onureg is used for AML

Onureg is used to continue AML treatment in adults who had complete remission after using chemotherapy as the first treatment for their AML. With complete remission, your symptoms of cancer disappear. Onureg can be used whether or not your blood cell counts improved after initial treatment with chemotherapy.

However, Onureg can only be used if you can’t continue treatment with an intensive curative therapy for AML. An intensive curative therapy uses both high-dose chemotherapy and a stem cell transplant to help cure AML.

Unlike curative therapy, Onureg works to reduce the likelihood that AML will return after you’ve reached complete remission.

Effectiveness for AML

Onureg is an effective option to continue treatment of AML that had complete remission with chemotherapy. But the AML couldn’t continue to be treated with intensive curative chemotherapy.

For information about how Onureg performed in clinical trials, see the drug’s prescribing information. Or, view Onureg’s patient brochure to find a discussion on the effectiveness of Onureg during clinical trials.

Onureg and children

Onureg isn’t approved for use in children with AML. It’s not known whether the medication is a safe or effective treatment option for children.

Onureg use with other drugs

Onureg is approved to treat acute myeloid leukemia (AML) in certain situations. For more information about this, see the “Onureg for AML” section above.

You’ll take Onureg over treatment cycles, which each last for 28 days.

For your first 2 cycles, your doctor will recommend that you take a nausea medication before each dose of Onureg. The nausea medication should be taken 30 minutes before your dose of Onureg. Doing this will help prevent nausea or vomiting from occurring after you’ve taken Onureg.

Some examples of nausea medications that may be used with Onureg include:

• ondansetron (Zofran)
• metoclopramide (Reglan)

After two treatment cycles with Onureg, you may be able to stop taking the nausea medication if you haven’t felt nauseous or vomited. But be sure to talk about this with your doctor.

Before stopping or starting any medications with Onureg, check with your doctor. They can recommend the treatment plan that’s right for you.

Onureg dosage

The Onureg dosage your doctor prescribes will depend on several factors. These include:

• other medical conditions you may have
• side effects that you’re having from Onureg

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Onureg comes as tablets that are taken by mouth. It’s available in two strengths: 200 milligrams (mg) and 300 mg.

It’s important to note that the active drug in Onureg, called azacitidine, also comes as forms that are given as an injection. However, Onureg can’t be substituted for the injectable forms of azacitidine. In fact, both the uses and the dosages for the injectable form of azacitidine are different than those of Onureg. So, be sure to only use Onureg if it’s prescribed by your doctor.

Dosage for AML

The Onureg dosage for acute myeloid leukemia (AML) is 300 mg taken once daily.

You’ll take Onureg over treatment cycles, which each last for 28 days. During a 28-day cycle, you’ll take Onureg on days 1 to 14.

If you have any side effects from Onureg, your doctor may recommend that you take a lower dose of the drug.

What if I miss a dose?

If you miss a dose of Onureg, take the drug as soon as possible if it’s still the same day that you missed a dose. If you missed your dose and it’s already the next day, skip the missed dose and take your next dose at the usual time.

Never take two doses of Onureg on one day to try to make up for a missed dose.

Along those lines, if you vomit after taking a dose of Onureg, don’t take another dose. Instead, just continue with your dose on the next day as usual.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Onureg is meant to be used as a long-term treatment. In fact, Onureg should be taken until either:

• you have side effects that are too severe or bothersome, or
• your AML worsens

If you and your doctor determine that Onureg is safe and effective for you, you’ll likely take it long term.

Onureg side effects

Onureg can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Onureg. These lists do not include all possible side effects.

For more information about the possible side effects of Onureg, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Onureg, you can do so through MedWatch.

Mild side effects

Mild side effects* of Onureg can include:

• nausea, vomiting, diarrhea, or constipation
• belly pain
• fatigue (lack of energy)
• weakness
• pneumonia
• joint pain
• pain in your arms or legs
• decreased appetite
• dizziness

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Onureg. To learn about other mild side effects, talk with your doctor or pharmacist, or view Onureg’s patient information.

Serious side effects

Serious side effects from Onureg aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects* can include:

• decreased blood cell counts
• allergic reaction

* For more information about these side effects, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Low blood cell counts

Onureg may cause some of your blood cell counts to decrease and become lower than normal. This was a common side effect in people taking Onureg during clinical studies. You may have a higher risk for this side effect if you already have low blood cell counts before you start using Onureg.

Specifically, Onureg may decrease your level of a type of white blood cell called neutrophils. Having a low neutrophil level is called neutropenia.

Neutrophils are important because they help your body fight off infections. If you’re exposed to germs while you have neutropenia, your body won’t be able to fight off the infection. With neutropenia you can also have a fever, which is a condition called febrile neutropenia. Febrile neutropenia is very serious and can be fatal if it’s not properly treated.

In addition, Onureg can decrease your level of platelets. Platelets are blood cells that help your blood form clots.

To monitor for lowered blood cell counts, your doctor will order blood tests throughout your Onureg treatment. If your blood cell counts begin to decrease, your doctor may lower your dose of the drug. Or, they may recommend medication to help increase your blood cell counts. If your blood cell counts become too low, your doctor may recommend a drug other than Onureg for you.

To find out how often lowered blood cell counts occurred during clinical studies of Onureg, see the drug’s prescribing information. And if you have any questions or concerns about low blood cell counts caused by Onureg, talk with your doctor.

Gastrointestinal problems

Gastrointestinal problems were the most common side effects in people taking Onureg during clinical studies. Gastrointestinal problems that are possible with Onureg include:

• nausea
• vomiting
• constipation
• diarrhea

To help prevent nausea and vomiting with Onureg, your doctor will recommend that you take a nausea medication during your first two treatment cycles with the drug. (Each cycle lasts for 28 days.) If the nausea medication isn’t working for you, talk with your doctor about other options that may work better.

If after your first 2 cycles with Onureg, you haven’t had nausea or vomiting, you and your doctor can decide whether you should continue taking the nausea medication. But don’t ever stop taking any medication without first discussing it with your doctor.

If you’re having constipation or diarrhea with Onureg, tell your doctor. They may recommend certain medications to take along with Onureg to help prevent these side effects.

To find out how often gastrointestinal problems occurred in clinical studies of Onureg, see the drug’s prescribing information. And if you have any questions or concerns about gastrointestinal problems with Onureg, talk with your doctor.

Fatigue and weakness

You may feel fatigued (lacking energy) or weak while you’re taking Onureg. These were common side effects in people during clinical trials of the drug.

If you’re feeling fatigued or weak during Onureg treatment, be sure to tell your doctor. They may recommend ways to help decrease these side effects. And they may be able to suggest ways to help you feel more energized during treatment.

To find out how often fatigue or weakness occurred in clinical studies of Onureg, see the drug’s prescribing information. And if you have any questions or concerns about fatigue or weakness with Onureg, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Onureg. Allergic reactions did occur in people during clinical trials of Onureg. However, it’s not known how common allergic reactions were during the trials.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Onureg, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Onureg and alcohol

There aren’t any known interactions between Onureg and alcohol. However, alcohol may cause some of the same side effects as Onureg. So, if you have dizziness, nausea, or vomiting with Onureg, drinking alcohol may make you feel worse.

If you drink alcohol, talk with your doctor to see if there’s a safe amount you can drink while you’re taking Onureg.

Onureg interactions

Onureg isn’t known to interact with other medications. It’s also not known to interact with any supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Before taking Onureg, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about possible drug interactions that may affect you, ask your doctor or pharmacist.

Onureg cost

As with all medications, the cost of Onureg can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Onureg. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for Onureg, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Onureg, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Onureg, or if you need help understanding your insurance coverage, help may be available.

Bristol-Myers Squibb, the manufacturer of Onureg, offers a program called BMS Access Support. Through this program, you may find financial assistance and help to lower the cost of Onureg. For more information and to find out if you’re eligible for support, call 800-861-0048 or visit the program website.

Mail-order pharmacies

Onureg may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Onureg, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Onureg is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

How to take Onureg

Onureg comes as tablets that you’ll take by mouth. You should take Onureg according to your doctor’s or healthcare provider’s instructions.

If the powder from Onureg tablets touches your skin, be sure to wash the affected area with soap and water right away. If the powder makes contact with your eyes or mouth, wash and flush the area with water as soon as possible.

When to take

You’ll take Onureg once daily on days 1 to 14 of each treatment cycle. (Treatment cycles each last for 28 days.) You should try to take the drug at about the same time each day.

For your first 2 cycles of treatment, you should take a nausea medication 30 minutes before taking your Onureg dose. After 2 cycles of treatment, you and your doctor can decide whether you need to continue taking the nausea medication.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Onureg with food

You can take your dose of Onureg with or without food.

Can Onureg be crushed, split, or chewed?

No, you shouldn’t split, crush, or chew Onureg tablets. Be sure to swallow the tablets whole.

How Onureg works

Onureg is used for continued treatment of a type of cancer called acute myeloid leukemia (AML), in certain situations. To learn more about Onureg’s approved uses, see the “Onureg for AML” section above.

AML is a type of cancer that causes your white blood cells to grow abnormally or make too many of themselves. AML can occur in your blood or bone marrow.

Onureg works by inserting itself into the cancer cells in your body. It’s believed that the drug works by turning on genes inside the cancer cells that cause the cancer cells to die.

Onureg should only be used once you’ve had complete remission of your AML after initial treatment with chemotherapy. With complete remission, your symptoms of cancer disappear. But Onureg can be used whether or not your blood cell counts improved after initial treatment with chemotherapy.

How long does it take to work?

Onureg will begin to work after you take your first dose of the medication. Keep in mind that the drug is used for continued treatment once you’ve had complete remission of AML. So, Onureg works to stop AML from returning.

Because of the way that Onureg works, you may not notice that it’s working. Talk with your doctor about how to know if Onureg is working for you.

Onureg and pregnancy

You shouldn’t take Onureg if you’re pregnant or planning to become pregnant. Because of the way this drug works, it can cause harm to a developing fetus.

There’s currently no information available about the use of Onureg in pregnant people. However, this medication caused problems, including pregnancy loss, when it was given to pregnant animals. These effects were seen when doses smaller than those recommended for humans were used. But keep in mind that animal studies don’t always predict what will happen in people.

If you’re a female* who’s able to become pregnant, your doctor will have you take a pregnancy test before you start using Onureg. If you’re pregnant or planning to become pregnant, be sure to tell your doctor before starting Onureg.

* In this article, the terms “male” and “female” refer to a person’s sex assigned at birth.

Onureg and fertility

Onureg may decrease your fertility (ability to reproduce). In animal studies, male animals that were given Onureg had decreased fertility and sperm count. And, female animals that were given Onureg had pregnancy loss.

If you have concerns about how Onureg may affect your fertility, talk with your doctor.

Onureg and birth control

You should not take Onureg if you’re pregnant or planning to become pregnant. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Onureg.

For more information about taking Onureg during pregnancy, see the “Onureg and pregnancy” section above.

Note: Below, we use the terms “male” and “female.” In this article, those terms refer to a person’s sex assigned at birth.

For females taking Onureg

If you’re a female who is able to become pregnant, you should take a pregnancy test before starting treatment with Onureg.

You should also use an effective form of birth control while you’re taking this drug. And you should continue to use effective birth control for at least 6 months after your last dose of the drug.

For males taking Onureg

If you’re a male with a female partner who is able to become pregnant, you should use effective birth control while taking Onureg. And you should continue to use effective birth control for at least 3 months after your last dose of the drug.

Onureg and breastfeeding

It’s not known if Onureg passes into human breast milk or if it may cause harm to a breastfed child. So, it’s not recommended that you breastfeed while you’re taking Onureg. This is because the drug could possibly cause serious side effects in a breastfed child.

Common questions about Onureg

Here are answers to some frequently asked questions about Onureg.

Is Onureg a chemotherapy drug?

Yes, Onureg is a chemotherapy drug that’s taken by mouth.

As a chemotherapy drug, it works by killing cancer cells in your body. But it can also kill some of your healthy cells. This accounts for some of the side effects of Onureg, such as low blood cell counts and nausea.

If you have additional questions about Onureg, see the “How Onureg works” section above or talk with your doctor.

Will I need to have lab tests done while I’m taking Onureg?

Yes, you’ll need to have your blood cell levels monitored while you’re taking Onureg.

Onureg can lower your levels of:

• white blood cells
• platelets (cells that help your blood to clot)

Because of this, your doctor will monitor your blood cell levels throughout your treatment with Onureg. If your levels start to decrease, your doctor may recommend a reduced dose of Onureg. Or, they may recommend other medications to help increase your white blood cell or platelets level.

If you have questions about the lab tests you’ll need while using this drug, talk with your doctor.

Can Onureg cure AML?

No, Onureg doesn’t cure acute myeloid leukemia (AML). Instead, the drug works to reduce the likelihood that AML will return after you’ve reached complete remission. (With complete remission, your symptoms of cancer disappear.)

Onureg can also prolong survival in people with AML who’ve reached complete remission.

Onureg can only be used if you can’t continue treatment with intensive curative therapy. Intensive curative therapy includes both high-dose chemotherapy and a stem cell transplant.

If you’d like to, talk with your doctor about whether treatment with an intensive curative therapy is an option for you.

Onureg precautions

Before taking Onureg, talk with your doctor about your health history. Onureg may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Low blood cell counts. Onureg may lower your level of certain blood cells, such as white blood cells and platelets (cells that form clots in your blood). If you already have low blood cell counts, taking Onureg may worsen your condition. Before you start taking Onureg, talk with your doctor about any conditions you have that cause you to have low blood cell counts.
• Kidney problems. Onureg hasn’t been studied in people with severe kidney problems. Because of this, be sure to tell your doctor about any kidney problems you may have. Your doctor may monitor your kidney function more often than usual while you’re taking Onureg. Or, they may recommend a medication other than Onureg to treat your AML.
• Liver problems. It’s not known if Onureg is safe for use in people with severe liver problems. Because of this, be sure to tell your doctor about any liver problems you may have. Your doctor may monitor your liver function more often than usual while you’re taking Onureg. Or, they may recommend a medication other than Onureg.
• Allergic reaction. If you’ve had an allergic reaction to Onureg or any of its ingredients, you shouldn’t take Onureg. Ask your doctor what other medications are better options for you.
• Pregnancy. You should not take Onureg if you’re pregnant or planning to become pregnant. This medication can be harmful to a developing fetus. For more information, see the “Onureg and pregnancy” section above.
• Breastfeeding. You should not take Onureg if you’re breastfeeding. For more information, see the “Onureg and breastfeeding” section above.

Note: For more information about the potential negative effects of Onureg, see the “Onureg side effects” section above.

Onureg overdose

Do not use more Onureg than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Onureg

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.