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ONUREG is a brand name for Azacitidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Do not substitute ONUREG for intravenous or subcutaneous azacitidine. 1 ). 2 ). 2 ). 1 Important Administration Information Do not substitute ONUREG for intravenous or subcutaneous azacitidine. 1) ]. 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.
5 Gi/L on Day 1 of a cycle, do not administer ONUREG. 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 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.
3 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. 5 Gi/L on Cycle Day 1 • Interrupt treatment. 5 Gi/L or higher. Neutrophils less than 1 Gi/L with fever at anytime First Occurrence • Interrupt treatment.
Resume at the same dose once neutrophils return to 1 Gi/L or higher. Occurrence in 2 Consecutive Cycles • Interrupt treatment. After neutrophils return to 1 Gi/L or higher, resume at reduced dose of 200 mg. • If a patient continues to experience febrile neutropenia after dose reduction, reduce the treatment duration by 7 days.
• If febrile neutropenia reoccurs after dose and schedule reduction, discontinue ONUREG. Platelets less than 50 Gi/L with bleeding First Occurrence • Interrupt dose. Resume at the same dose once platelets return to 50 Gi/L or higher.
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.
gov/medwatch . 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.
3 months) and the median number of cycles was 12 (range: 1 to 82 cycles). Serious adverse reactions occurred in 15% of patients who received ONUREG. Serious adverse reactions in ≥ 2% of patients who received ONUREG were pneumonia (8%) and febrile neutropenia (7%).
One fatal adverse reaction (sepsis) occurred in a patient who received ONUREG. Permanent discontinuation of ONUREG due to an adverse reaction occurred in 8% of patients. 3%). Interruptions of ONUREG due to an adverse reaction occurred in 35% of patients.
Adverse reactions which required an interruption of ONUREG in > 5% of patients included neutropenia (20%), thrombocytopenia (8%), and nausea (6%). Dose reductions of ONUREG due to an adverse reaction occurred in 14% of patients. 7%).
The most common (≥ 10%) adverse reactions were 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.
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. 2 ). • Embryo-Fetal Toxicity : Can cause fetal harm.
3 ). 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. 1) ] . 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.
3) ]. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs. 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.
2) , Description (11) ] . History of severe hypersensitivity to azacitidine or its components ( 4 ).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Occurrence in 2 Consecutive Cycles • Interrupt dose. After platelets return to 50 Gi/L or higher, resume at reduced dose of 200 mg. • If a patient continues to experience thrombocytopenia with bleeding after dose reduction, reduce the treatment duration by 7 days.
• If thrombocytopenia with bleeding reoccurs after dose and schedule reduction, discontinue ONUREG. 1) ] Grade 3 or 4 Nausea or Vomiting • Interrupt dose. Resume at the same dose once toxicity has resolved to Grade 1 or lower. • If toxicity reoccurs, interrupt dose until resolved to Grade 1 or lower.
Resume at reduced dose of 200 mg. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG.
Grade 3 or 4 Diarrhea • Interrupt dose. Resume at the same dose once toxicity has resolved to Grade 1 or lower. • If toxicity reoccurs, interrupt dose until resolved to Grade 1 or lower. Resume at reduced dose of 200 mg. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days.
• If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG. 1) ] Grade 3 or 4 • Interrupt dose and provide medical support. Resume at the same dose once toxicity has resolved to Grade 1 or lower. • If toxicity re-occurs, interrupt dose until resolved to Grade 1 or lower.
Resume at reduced dose of 200 mg. • If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days. • If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG.
Table 2 summarizes the adverse reactions in QUAZAR.
Table 2:
Adverse Reactions (≥ 5%) in Patients with AML Who Received ONUREG with a Difference Between Arms of > 2% Compared to Placebo in QUAZAR Adverse Reaction ONUREG (N=236) Placebo (N=233) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) a Grouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, and gastrointestinal pain.
b Grouped term includes fatigue and asthenia. c Broad scope term includes acute sinusitis, adenoviral upper respiratory infection, chronic tonsillitis, influenza, nasopharyngitis, pharyngitis, rhinitis, sinusitis, sinusitis fungal, tonsillitis, tracheitis, upper respiratory tract infection, upper respiratory tract infection bacterial, viral pharyngitis, viral rhinitis, viral upper respiratory tract infection.
d Broad scope term includes influenza, pneumonia, respiratory tract infection, respiratory tract infection viral, bronchopulmonary aspergillosis, lung infection, Staphylococcal infection, atypical pneumonia, lower respiratory tract infection, lung abscess, Pneumocystis jirovecii pneumonia, pneumonia bacterial, pneumonia fungal, Pseudomonas infection, hemoptysis, productive cough, pleural effusion, atelectasis, pleuritic pain, rales, Enterobacter test positive, and Hemophilus test positive.
Gastrointestinal disorders Nausea 65 3 24 < 1 Vomiting 60 3 10 0 Diarrhea 50 5 21 1 Constipation 39 1 24 0 Abdominal pain a 22 2 13 < 1 General disorders and administration site conditions Fatigue / asthenia b 44 4 25 1 Infections Upper respiratory tract infection c 34 2 28 0 Pneumonia d 27 9 17 5 Skin infection e 11 3 8 1 Sepsis f 6 g 5 3 3 Musculoskeletal and connective tissue disorders Arthralgia 14 1 10 < 1 Pain in extremity 11 < 1 5 0 Metabolism and nutrition disorders Decreased appetite 13 1 6 1 Blood and lymphatic disorders Febrile neutropenia 12 11 8 8 Nervous system disorders Dizziness 11 0 9 0 e Broad scope term includes cellulitis, erythema migrans, folliculitis, fungal skin infection, furuncle, herpes simplex, herpes zoster, nail bed infection, nail infection, onychomycosis, skin infection, staphylococcal skin infection.
f Grouped term includes: Sepsis, bacterial sepsis, neutropenic sepsis, device related sepsis, Klebsiella sepsis, Septic shock, Staphylococcal sepsis, and urosepsis. g Includes 1 fatal adverse reaction. Clinically relevant adverse reactions in less than 5% of patients who received ONUREG included Investigations: Weight decreased Neutropenia, thrombocytopenia, and anemia of any grade occurred in 74%, 65%, and 25% of patients who received ONUREG.
Table 3 summarizes select Grades 3 or 4 hematological laboratory abnormalities in QUAZAR. 2 Postmarketing 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
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. 3) ] .