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Full Prescribing Information

Patient Information

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Indication

 

About ONUREG®

Why ONUREG?
 

How was ONUREG studied?

ONUREG was studied in a large clinical trial
 

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  • ONUREG was tested against placebo
    • A placebo is an inactive medicine that can help test the effectiveness of a new treatment in a clinical trial
  • 238 people were treated with ONUREG and 234 people were treated with placebo
  • People in the trial were between 55 and 86 years old
  • Everyone was in first remission following intensive induction chemotherapy with or without consolidation therapy
  • The trial only included people who were not planning to receive a transplant

ONUREG helped patients like you live longer

People treated with ONUREG had longer median overall survival

Half the people in the trial were still alive at:

Median overall survival


Additional results* from the study showed:
 

Estimated overall survival

~Three out of four (73%) people who received ONUREG were alive at one year

~Two out of four (56%) people who received placebo were alive at one year

These outcomes were experienced by people in the ONUREG clinical trial. Your results may vary.

* Important to know: Estimated overall survival results should be viewed with caution. The ONUREG trial was designed to compare median overall survival with ONUREG versus placebo. It was not designed to compare survival at other time points.

 

What is overall survival?

 

Overall survival

Overall survival is an important data point that is one way to show how well a treatment works in a clinical trial

  • It represents the length of time that a person lives after starting a medication
  • When an AML medication achieves longer overall survival, it offers people the chance for more life
Overall survival

In the ONUREG clinical trial, median overall survival was used to compare:

The length of time when 50% (or half) the people treated with ONUREG were still alive

vs

The length of time when 50% (or half) the people treated with placebo were still alive

Onureg DTC ISI Contents

Important facts 
about ONUREG® 
(azacitidine)

This is a summary of important information that you need to know about ONUREG. Your healthcare provider can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.

Look out for the following icons as you read:

Talk to your
healthcare team

Call your healthcare
provider right away

Helpful information
to remember

What is ONUREG?

ONUREG (azacitidine) is an oral prescription medicine used to treat adults with acute myeloid leukemia (AML) who:

Are in first complete remission (CR) (with or without recovery of your blood cell counts) after intensive induction chemotherapy and are not able to complete intensive curative therapy.

It is not known if ONUREG is safe and effective in children under 18 years of age.

Do not take ONUREG if you are allergic to azacitidine or any of the ingredients in ONUREG.

Talk to your healthcare team for more information about what it means to be in first complete remission.

Before taking ONUREG, what should I discuss with my healthcare team?

Talk to your healthcare team about all of your medical conditions, including if you have kidney or liver problems.

Talk to your healthcare team about all the medicines you are taking, including:

  • Prescription medicines
  • Over-the-counter medicines
  • Vitamins
  • Herbal supplements

These are not all the topics you should discuss with your healthcare team. Talk to your healthcare team about anything you might be unsure of before starting treatment.

 

Before taking ONUREG, what should I discuss with my healthcare team about potential serious fertility side effects, pregnancy, birth control, and breastfeeding?

Talk to your healthcare team about fertility planning, birth control, and the best way to feed your baby during treatment with ONUREG.

If you are pregnant, plan to become pregnant, or your partner plans to become pregnant: ONUREG may harm your unborn baby.

If you are female (sex assigned at birth):
If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ONUREG. You should use effective birth control (contraception) during treatment and for at least 6 months after your last dose of ONUREG.

If you are male (sex assigned at birth) with a sexual partner who can become pregnant:
You should use effective birth control (contraception) during treatment and for at least 3 months after your last dose of ONUREG.

ONUREG may cause fertility problems in all genders and may affect your ability to have children. Talk to your healthcare team if fertility problems are a concern for you.

If you are breastfeeding or plan to breastfeed: It is not known if ONUREG passes into your milk.
Do not breastfeed during treatment and for 1 week after your last dose of ONUREG.

Call your healthcare provider right away if you or your partner becomes pregnant during treatment with ONUREG.

What are the serious side effects of ONUREG?

ONUREG can cause serious side effects. A serious side effect is a side effect that can be life-altering or can sometimes become life-threatening and can lead to hospitalization or death. The serious side effects of ONUREG may include:

New or worsening low white blood cell counts (neutropenia). New or worsening low white blood cell counts are common but can also be severe during treatment with ONUREG. If your white blood cell counts become very low, you are at higher risk for infections. Your healthcare provider will check your white blood cell counts before and during treatment with ONUREG. If needed, your healthcare provider may prescribe a medicine to help increase your white blood cell count.

Call your healthcare provider right away if you have any of the following symptoms:

  • Fever or chills
  • Feeling very tired or weak
  • Body aches
  • Headaches that are different from what you are used to

New or worsening low platelet counts (thrombocytopenia). Low platelet counts are common but can also be severe during treatment with ONUREG. Your healthcare provider will check your platelet counts before and during treatment with ONUREG.

Call your healthcare provider right away if you have any unusual bruising or bleeding.

What are the most common side effects of ONUREG?

The most common side effects of ONUREG can include:

  • Nausea and vomiting
  • Diarrhea
  • Feeling tired or weak
  • Constipation
  • Pain in the stomach (abdominal) area
  • Pneumonia
  • Joint pain
  • Decreased appetite
  • Pain in your arms or legs
  • Feeling dizzy

Talk to your healthcare team if you experience nausea, vomiting, or diarrhea while you are taking ONUREG.

  • For nausea and vomiting: You will be prescribed an anti-nausea medication to take before each dose of ONUREG. Talk to your healthcare provider if you haven't been prescribed an anti-nausea medication. If you do not have any nausea or vomiting after your second treatment cycle of ONUREG, your healthcare provider may decide to stop the anti-nausea medication.
  • For diarrhea: If you experience diarrhea, you may be treated with anti-diarrheal medication.

These are not all of the possible side effects of ONUREG.

Talk to your healthcare team for more information or advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

How will I take ONUREG?

Take ONUREG exactly as your healthcare provider tells you. The recommended dose of ONUREG is one 300 mg tablet taken by mouth 1 time a day for weeks 1 and 2 of each treatment cycle. If you develop certain side effects, your healthcare provider may pause your treatment, decrease your dose, or decrease the number of treatment days. If your side effects persist, your healthcare provider may ask you to stop taking ONUREG permanently.

You will take ONUREG in treatment cycles that repeat every 4 weeks:

  • During weeks 1 and 2: Take 1 tablet by mouth, 1 time each day
  • During weeks 3 and 4: Do not take any ONUREG
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Do take ONUREG with or without food

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Do take an anti-nausea medication 30 minutes before your ONUREG dose as prescribed by your healthcare provider

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Do take ONUREG at about the same time each day

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Do swallow ONUREG tablets whole

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Do not cut, crush, or chew ONUREG tablets

What if I vomit or miss a dose of ONUREG?

Do not take an extra dose.

  • If you forget to take your dose at your regularly scheduled time: Take the dose as soon as possible that day. Do not take 2 doses on the same day. Take your next dose at the regularly scheduled time the next day.
  • If you vomit after taking a dose of ONUREG: Do not take another dose on the same day. Take your next dose at the regularly scheduled time the next day.

Setting an alarm clock or a calendar notification is a great way to remember to take medication.

ONUREG is available in two different tablets. ONUREG tablets are oval with a colored coating. Each tablet is marked with the letters 'ONU' on one side and the numbers '300' or '200' on the other.

ONUREG pills (300 mg and 200 mg)

Note: Images do not represent actual tablet sizes

Inactive ingredients:

  • All ONUREG tablets contain: croscarmellose sodium, magnesium stearate, mannitol, silicified microcrystalline cellulose, hypromellose, iron oxide red, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin
  • The brown 300 mg tablet coating also contains: black iron oxide, iron oxide yellow

The powder inside ONUREG tablets should not come in contact with your skin, eyes, or mouth. Do not cut, crush, or chew ONUREG tablets. Do not take broken or damaged tablets. If the powder comes in contact with your:

  • eyes or mouth (mucous membranes): flush the area right away with water
  • skin: wash the area right away with soap and water

How should I store ONUREG?

Keep your ONUREG tablets in the containers they came in.

Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep ONUREG and all medicines out of reach of children.

How do I get rid of any unused or expired ONUREG?

Talk to your healthcare team about how to safely throw away (dispose of) any unused or expired ONUREG.

What else should I know about ONUREG?

Do not use ONUREG for a condition that it is not prescribed for. Sometimes ONUREG is prescribed for purposes other than those mentioned in the Patient Information leaflet.

Do not give ONUREG to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare team for information about ONUREG that is written for healthcare providers.

For more information, please see U.S. Full Prescribing Information and Patient Information for ONUREG. Talk to your healthcare provider for more information about this medication.
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2011-US-2400063 06/24