Onureg (azacitidine)

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.

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
  • body aches
  • feeling very tired or weak
  • 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.
• 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.

Important Administration Information

Do not substitute Onureg for intravenous or subcutaneous azacitidine. The indications and dosing regimen for Onureg differ from that of intravenous or subcutaneous azacitidine.

Recommended Dosage

The recommended dosage of Onureg is 300 mg orally once daily with or without food on Days 1 through 14 of each 28-day cycle. Continue Onureg until disease progression or unacceptable toxicity.

Administer an antiemetic 30 minutes prior to each dose of Onureg for the first 2 cycles. Antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting.

If the absolute neutrophil count (ANC) is less than 0.5 Gi/L on Day 1 of a cycle, do not administer Onureg. Delay the start of the cycle until the ANC is 0.5 Gi/L or more.

Instruct patients on the following:

• Do not split, crush, or chew Onureg tablets.
• Take a dose about the same time each day.
• If a dose of Onureg is missed, or not taken at the usual time, take the dose as soon as possible on the same day, and resume the normal schedule the following day. Do not take 2 doses on the same day.
• If a dose is vomited, do not take another dose on the same day. Resume the normal schedule the following day.

Onureg is a hazardous drug. Follow applicable special handling and disposal procedures.¹

Monitoring And Dosage Modifications For Adverse Reactions

Monitor complete blood count every other week for the first 2 cycles and prior to the start of each cycle thereafter. Increase monitoring to every other week for the 2 cycles after any dose reduction for myelosuppression.

The recommended dosage modifications for adverse reactions are provided in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions

• Based on its mechanism of action and findings in animals, Onureg can cause fetal harm when administered to a pregnant woman.
• There are no available data on Onureg use in pregnant women to evaluate for a drug-associated risk.
• There are no data regarding the presence of azacitidine in human milk or the effects on the breastfed child or milk production.
• Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Onureg and for 1 week after the last dose.