onureg
Onureg (Azacitidine) is a nucleoside metabolic inhibitor used to treat Refractory Anemia, Sideroblastic Anemia, Chronic Myelomonocytic Leukemia.
Azacitidine · by Bristol
Available as a generic: Azacitidine
Key facts
- Active ingredient
- Azacitidine
- Drug class
- Nucleoside Metabolic Inhibitor
- Form
- Tablet
- Strength
- Azacitidine 200MG · Azacitidine 300MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bristol
- FDA application
- NDA214120
What is Onureg?
From the FDA label:Azacitidine is a nucleoside metabolic inhibitor with a molecular formula of C 8 H 12 N 4 O 5 and a molecular weight of 244 g/mol. The chemical name is: 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one and the chemical structural is: 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. onureg-chem-structure
How to use
Do not substitute ONUREG for intravenous or subcutaneous azacitidine. The indications and dosing regimen for ONUREG differ from that of intravenous or subcutaneous azacitidine ( 2.1 , 5.1 ). • Administer ONUREG 300 mg orally once daily on Days 1 through 14 of each 28-day cycle ( 2.2 ). • Administer an antiemetic before each dose for at least the first 2 cycles ( 2.2 ). 2.1 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 [see Warnings and Precautions (5.1) ]. 2.2 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: • Swallow tablets whole. Do not cut, crush, or chew the tablets. • Take a dose about the same time each day. • If a dose of ONUREG is missed, or not taken at the…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 10%) are nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, skin infection, and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb Company at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Acute Myeloid Leukemia The safety of ONUREG was evaluated in QUAZAR [see Clinical Studies (14) ] . Patients received ONUREG 300 mg (N=236) or placebo (N=233) orally once daily on Days 1 through 14 of each 28-day cycle. Among patients who received ONUREG, 71% were exposed for 6 months or longer, and 49% were exposed for greater than one year. The median duration of exposure to ONUREG was 11.6 months (range: 0.5 to 74.3 months) and the median number of cycles was 12 (range: 1 to 82 cycles). Serious adverse reactions occurred in 15%…
Warnings
Important safety information
Risks of Substitution with Other Azacitidine Products : Do not substitute ONUREG for intravenous or subcutaneous azacitidine ( 2.1 , 5.1 ). • Myelosuppression : Monitor complete blood counts 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. Withhold and then resume at same or reduced dose or discontinue ONUREG based on severity ( 2.3 , 5.2 ). • Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and use of effective contraception ( 5.4 , 8.1 , 8.3 ). 5.1 Risks of Substitution with Other Azacitidine Products Due to substantial differences in the pharmacokinetic parameters [see Clinical Pharmacology (12.3) ] , the recommended dose and schedule for ONUREG are different from those for the intravenous or subcutaneous azacitidine products. Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of ONUREG may result in a fatal adverse reaction. Treatment of patients using ONUREG at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute ONUREG for intravenous or subcutaneous azacitidine [see Dosage and Administration (2.1) ] . 5.2 Myelosuppression New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG, respectively. Febrile neutropenia occurred in 12% , and sepsis was reported in 6%, including 1 fatal case . A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively. Less than 1% of patients discontinued ONUREG due to either neutropenia or thrombocytopenia. Monitor complete blood counts and modify the dosage as recommended [see Dosage and Administration (2.2 , 2.3) ]. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs. 5.3 Increased Early Mortality in Patients with Myelodysplastic Syndromes In AZA-MDS-003 (NCT01566695), 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to myelodysplastic syndromes were randomized to ONUREG or placebo. One-hundred and seven patients received a median of 5 cycles of ONUREG 300 mg daily for 21 days of a 28-day cycle. Enrollment was discontinued early due to a higher incidence of early fatal and/or serious adverse reactions in patients who received ONUREG compared with placebo. The most frequent fatal adverse reaction was sepsis. The safety and effectiveness of ONUREG for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with ONUREG is not recommended outside of controlled trials. 5.4 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, ONUREG can cause fetal harm when administered to a pregnant woman. Azacitidine administered to pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m 2 basis caused fetal death and anomalies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ONUREG and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ONUREG and for at least 3 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ] .
Who should not take Onureg
ONUREG is contraindicated in patients with known severe hypersensitivity to azacitidine or its components [see Adverse Reactions (6.2) , Description (11) ] . History of severe hypersensitivity to azacitidine or its components ( 4 ).
Drug class
How this class works, per Gemcitabine — LiverTox, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Onureg ranks — best-rated nucleoside metabolic inhibitor for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Onureg treat?
- Onureg (Azacitidine) may be used to treat refractory anemia, sideroblastic anemia, chronic myelomonocytic leukemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Onureg work?
- Onureg is a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die.
- Is there a coupon or discount for Onureg?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Onureg. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Onureg?
- Onureg is marketed by Bristol. You can see Bristol's full profile, rating, and other products on pharmaranks.
- Is Onureg a brand-name or generic drug?
- Onureg is a brand-name product with the active ingredient Azacitidine. Lower-cost generic equivalents containing Azacitidine are available — ask your pharmacist.
- Is Onureg available over the counter?
- No. Onureg is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Onureg come in?
- Onureg is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Onureg?
- Onureg is classified as nucleoside metabolic inhibitor, per the FDA's Established Pharmacologic Class.
- Is Onureg FDA-registered?
- Onureg is on record with the U.S. FDA under application number NDA214120. You can verify this on its official FDA label.
- Is Onureg safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Onureg. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Onureg?
- Onureg's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 10%) are nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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