ONUREG® (azacitidine) tablets 300mg & 200mg logo

About AML

FOR ADULT PATIENTS. It is not known if ONUREG® is safe and effective in children under 18 years of age.
What is acute myeloid leukemia? AML treatment

What is AML
(acute myeloid leukemia)?

AML is a blood cancer that
starts in the bone marrow

The bone marrow is a soft tissue found within the bones

Bone marrow typically produces platelets (which help with blood clotting), red blood cells (which transport oxygen throughout the body), and white blood cells (which help fight infection)

In most cases, AML can quickly move from the bone marrow into the blood and can sometimes spread to other parts of the body

Platelet
Red Blood Cell
White Blood Cell
Leukemic Cell
Blast Cell

In AML, the bone marrow makes abnormal blood cells

Normally, the bone marrow makes immature cells that go on to become mature blood cells

In AML, blood cells don’t form properly in the bone marrow and young, immature cells, called myeloblasts, or blasts for short, are produced instead. Blasts are unable to fight infections the way healthy blood cells can

As the bone marrow produces more and more blasts, there is no room for the production of normal platelets, red blood cells, and white blood cells. When there are too many blasts and not enough healthy cells, the symptoms of AML begin to occur

Interested in more
information?

Gain more clarity on AML and
ONUREG® treatment in the glossary

View Now

Treatment for someone
with AML typically starts
as soon as possible

Acute means that this disease can get
worse quickly if left untreated.

Depending on factors like age or the type of AML, a person with AML may receive a few treatments before they start to feel better.

As Soon as Possible Icon
What is acute myeloid leukemia? AML treatment

A main goal of treatment is to eliminate the blasts in the blood and bone marrow

The first phase of treatment, called induction therapy, is usually the strongest against blasts.

The goal of induction therapy is to achieve complete remission. Complete remission, or remission for short,
describes the absence of signs and symptoms of AML.*

Continued treatment
for AML

Your healthcare team will decide if treatment after remission is necessary

Goals of treatment may include preventing AML from returning and helping patients live longer.*

Post-remission treatment options include:

  • Additional chemotherapy: Consists of similar drugs used during induction, however, at different doses.
    This treatment is also known as consolidation therapy
  • Bone marrow transplant: Involves transferring healthy stem cells from a donor to a person with AML.
    This treatment is also known as a stem cell transplant or a hematopoietic stem cell transplant

Continued treatment is another post-remission option for AML

Potential treatment journey for people with AML
Intensive induction therapy
First remission
Consolidation
therapy
(+/-)
Continued treatment with ONUREG®
*

National Comprehensive Cancer Network® makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

IMPORTANT SAFETY INFORMATION

Do not take ONUREG® if you:

are allergic to azacitidine or any of the ingredients in ONUREG®. See the Patient Information for a complete list of ingredients in ONUREG®.

Before taking ONUREG®, tell your healthcare provider about all of your medical conditions, including if you:
  • have kidney or liver problems.
  • are pregnant or plan to become pregnant. ONUREG® can harm your unborn baby.
Females who are able to become pregnant:
  • Your healthcare provider should perform 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®.
  • Tell your healthcare provider right away if you become pregnant during treatment with ONUREG®.
Males with a female 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®.
  • are breastfeeding or plan to breastfeed. It is not known if ONUREG® passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of ONUREG®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take ONUREG®?
  • Take ONUREG® exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will prescribe an anti-nausea medicine for you to take to help prevent nausea and vomiting during your treatment with ONUREG®.
  • Take the anti-nausea medicine 30 minutes before each dose of ONUREG®.
  • Your healthcare provider may decide to stop the anti-nausea medicine after your second cycle of ONUREG®, if you do not have any nausea or vomiting.
  • Take ONUREG® by mouth 1 time each day beginning on Day 1 through Day 14 of each 28-day cycle.
  • Take ONUREG® with or without food at about the same time each day.
  • Swallow ONUREG® tablets whole. Do not cut, split, crush, or chew the tablets.
  • If the powder from ONUREG® tablets comes in contact with your skin, wash the area well right away with soap and water. If the powder from ONUREG® tablets comes in contact with your eyes or mouth (mucous membranes), flush the area right away with water.
  • If you miss a dose of ONUREG®, or if you do not take your dose at the usual time, take the dose as soon as possible that day. Take your next dose at the regular time the next day. Do not take 2 doses on the same day to make up for a missed dose.
  • If you vomit after taking a dose of ONUREG®, do not take another dose on the same day. Take your next dose at the regular time the next day.
What are the possible side effects of ONUREG®?
ONUREG® can cause serious side effects, including:
  • 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 increased risk for infections. Your healthcare provider will check your white blood cell counts before and during treatment with ONUREG®. Your healthcare provider may prescribe a medicine to help increase your white blood cell count if needed.

Tell your healthcare provider right away if you get any of the following symptoms:

  • fever or chills
  • feeling very tired or weak
  • body aches
  • unusual headaches
  • 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®. Tell your healthcare provider right away if you have any unusual bruising or bleeding. Your healthcare provider may change your dose or tell you to stop taking ONUREG® if you have low blood cell counts.

ONUREG® may cause fertility problems in males and females, which may affect your ability to have children. Talk with your healthcare provider if you have concerns about fertility.

The most common side effects of ONUREG® include:
  • nausea and vomiting. See “How should I take ONUREG®?”
  • diarrhea. You may need to be treated with anti-diarrheal medicines.
  • tiredness or weakness
  • constipation
  • stomach area (abdominal) pain
  • pneumonia
  • joint pain
  • decreased appetite
  • pain in arms or legs
  • dizziness

These are not all of the possible side effects of
ONUREG®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

General information about the safe and effective use of ONUREG®.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ONUREG® for a condition for which it was not prescribed. Do not give ONUREG® to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ONUREG® that is written for health professionals.

What is ONUREG®?

ONUREG® is a prescription medicine used for continued 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. It is not known if ONUREG® is safe and effective in children under 18 years of age.

Please see full Prescribing Information and Patient Information for ONUREG®.

This website is best viewed
using the horizontal display
on your tablet device.

This website is best viewed
using the vertical display on
your mobile device.