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Generic Name
AzaCITIDine
Brand Names
Onureg, Vidaza
FDA approval date: July 05, 2004
Classification: Nucleoside Metabolic Inhibitor
Form: Injection, Tablet
What is Onureg (AzaCITIDine)?
ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy .
Approved To Treat
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Brand Information
ONUREG (azacitidine)
1INDICATIONS AND USAGE
ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 200 mg, pink, oval, film-coated tablet with debossed "200" on one side and "ONU" on the other side.
- 300 mg, brown, oval, film-coated tablet with debossed "300" on one side and "ONU" on the other side.
3CONTRAINDICATIONS
ONUREG is contraindicated in patients with known severe hypersensitivity to azacitidine or its components
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelosuppression
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of intravenous or subcutaneous azacitidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity reaction
- Interstitial lung disease
- Tumor lysis syndrome
- Sweet's syndrome (acute febrile neutrophilic dermatosis)
- Necrotizing fasciitis (including fatal cases)
- Differentiation syndrome
5DESCRIPTION
Azacitidine is a nucleoside metabolic inhibitor with a molecular formula of C
Azacitidine is a white to off-white solid. Azacitidine was found to be soluble in aqueous media across a pH range from 1.0 to 7.0.
ONUREG (azacitidine) is supplied as film-coated tablets containing 200 mg or 300 mg of azacitidine for oral use. Each core tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose. The 200 and 300 mg tablet coating contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. In addition, the 200 mg tablet coating contains iron oxide red and the 300 mg tablet coating contains black iron oxide, iron oxide red, and iron oxide yellow.
6CLINICAL STUDIES
The efficacy of ONUREG was evaluated in QUAZAR (NCT01757535), a multicenter, randomized, double-blind, placebo-controlled study. Eligible patients were ages 55 years or older, had AML, and were within 4 months of achieving first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with intensive induction chemotherapy. Patients may have received consolidation (see
A total of 472 patients who completed induction with or without consolidation therapy were randomized 1:1 to receive ONUREG 300 mg (n=238) or placebo (n=234) orally on Days 1 through 14 of each 28-day cycle. Randomization was stratified by age at time of induction therapy (55 to 64 vs. ≥ 65 years), cytogenetic risk category at time of induction therapy (intermediate risk vs. poor risk), prior history of MDS/CMML (yes vs. no), and received consolidation therapy following induction therapy (yes vs. no). Baseline demographic and disease characteristics are shown in Table 4.
The efficacy of ONUREG was established on the basis of overall survival (OS). The trial demonstrated a statistically significant improvement in OS for patients randomized to ONUREG compared to placebo. A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi. The efficacy results are summarized in Table 5 and Figure 1.
Figure 1: Kaplan-Meier Curve for Overall Survival (ITT Population) in QUAZAR
7REFERENCES
1. "OSHA Hazardous Drugs."
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9Patient Package Insert
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: June 2026
10PRINCIPAL DISPLAY PANEL - 200 mg Blister Pack Carton
NDC 59572-730-07
ONUREG™
200 mg
Each tablet contains 200 mg of azacitidine.
Swallow tablets whole. Do not cut, crush, or chew the tablets.
One Blister Card
Bristol Myers Squibb
CAUTION: Hazardous Agent
11PRINCIPAL DISPLAY PANEL - 300 mg Blister Pack Carton
NDC 59572-740-07
ONUREG™
300 mg
Each tablet contains 200 mg of azacitidine.
Swallow tablets whole. Do not cut, crush, or chew the tablets.
One Blister Card
Bristol Myers Squibb
CAUTION: Hazardous Agent
