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:
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:
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.
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®.