Onureg

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/8/2021
Onureg Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Onureg?

Onureg (azacitidine) is a nucleoside metabolic inhibitor 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.

What Are Side Effects of Onureg?

Side effects of Onureg include:

Dosage for Onureg

The dose of Onureg is 300 mg administered orally once daily on Days 1 through 14 of each 28-day cycle.

Onureg In Children

The safety and effectiveness of Onureg in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Onureg?

Onureg may interact with other medicines.

Tell your doctor all medications and supplements you use.

Onureg During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Onureg; it may harm a fetus. Pregnancy testing is recommended for females of reproductive potential before starting Onureg. Females of reproductive potential are advised to use effective contraception during treatment with Onureg and for at least 6 months after the last dose. Males with female partners of reproductive potential are advised to use effective contraception during treatment with Onureg and for at least 3 months after the last dose. It is unknown if Onureg passes into breast milk. Because of the potential for serious adverse reactions in the breastfed child, women are advised not to breastfeed during treatment with Onureg and for 1 week after the last dose.

Additional Information

Our Onureg (azacitidine) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Onureg Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing nausea, vomiting, or diarrhea;
  • redness, swelling, warmth, oozing, or other signs of skin infection;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • signs of a lung infection--fever, cough with mucus, chest pain, feeling short of breath;
  • kidney problems--pain in your lower back, blood in your urine, little or no urination, swelling in your feet or ankles;
  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • fever, chills, bruising, or other signs of low blood cell counts;
  • lung infection;
  • low potassium;
  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation, diarrhea;
  • joint pain, pain in your arms or legs;
  • feeling weak or tired;
  • dizziness; or
  • redness where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Onureg (Azacitidine Tablets)

Onureg Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]

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]. 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% 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. Adverse reactions which resulted in permanent discontinuation of ONUREG in > 1% of patients included nausea (2.1%), diarrhea (1.7%), and vomiting (1.3%). 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. Adverse reactions which required a dose reduction in > 1% of patients included neutropenia (6%), diarrhea (3.4%), thrombocytopenia (1.7%), and nausea (1.7%).

The most common (≥ 10%) adverse reactions were nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremity.

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 ReactionONUREG
(N=236)
Placebo
(N=233)
All Grades (%)Grade 3 or 4 (%)All Grades (%)Grade 3 or 4 (%)
Gastrointestinal disorders
Nausea65324< 1
Vomiting603100
Diarrhea505211
Constipation391240
Abdominal paina22213< 1
General disorders and administration site conditions
Fatigue / astheniab444251
Infections
Pneumoniac279175
Musculoskeletal and connective tissue disorders
Arthralgia14110< 1
Pain in extremity11< 150
Metabolism and nutrition disorders
Decreased appetite13161
Blood and lymphatic disorders
Febrile neutropenia121188
Nervous system disorders
Dizziness11090
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 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.

Clinically relevant adverse reactions that did not meet criteria for inclusion in Table 2 were weight decreased (4%) in patients who received ONUREG.

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.

Table 3: Selected Hematological Laboratory Abnormalities That Worsened from Baseline in Patients Who Received ONUREG in QUAZAR

Laboratory AbnormalityONUREGPlacebo
Baseline Grade 0-2 NPost-Baseline Grade 3 or 4 n (%)Baseline Grade 0-2 NPost-Baseline Grade 3 or 4 n (%)
Neutropenia223109 (49)21750 (23)
Thrombocytopenia22246 (21)21222 (10)
Anemia22910 (4)2237 (3)

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

Read the entire FDA prescribing information for Onureg (Azacitidine Tablets)

© Onureg Patient Information is supplied by Cerner Multum, Inc. and Onureg Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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