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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.

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Safety

  • Warnings and Precautions
  • Adverse Reactions
  • Discontinuations and Dose Modifications

Warnings and Precautions

Risks of substitution with other
azacitidine products1

  • Due to substantial differences in the pharmacokinetic parameters, 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

Myelosuppression1

  • 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%
  • A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively
  • <1% of patients discontinued ONUREG® due to either neutropenia or thrombocytopenia
  • Monitor complete blood counts and modify the dosage as recommended
  • Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs

Increased early mortality in patients
with myelodysplastic syndromes1

  • 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
  • 107 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

Embryo-fetal toxicity1

  • 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/m2 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

ONUREG® safety was assessed in the QUAZAR® AML-001 trial1

  • 1 fatal AR (sepsis) occurred in a patient who received ONUREG®1
  • Serious ARs occurred in 15% of patients receiving ONUREG®1
    • Serious ARs in ≥2% of patients who received ONUREG® were pneumonia (8%) and febrile neutropenia (7%)

The majority of ARs were mild to moderate (Grade 1 or 2) with ONUREG®1

ARs (≥5%) in patients with AML who received ONUREG® with a difference between arms of >2% compared with placebo in QUAZAR® AML-0011

AR

ONUREG®(n=236)

Placebo(n=233)

All Grades
(%)

Grade 3 or 4
(%)

All Grades
(%)

Grade 3 or 4
(%)

Gastrointestinal (GI) disorders

Nausea

65

3

24

<1

Vomiting

60

3

10

0

Diarrhea

50

5

21

1

Constipation

39

1

24

0

Abdominal paina

22

2

13

<1

General disorders and administration site conditions

Fatigue/astheniab

44

4

25

1

Infections

Pneumoniac

27

9

17

5

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

aGrouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, and GI pain.

bGrouped term includes fatigue and asthenia.

cBroad 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 Haemophilus test positive.

Selected hematological laboratory abnormalities that worsened from baseline in patients who received ONUREG® in QUAZAR® AML-0011

Laboratory
abnormality

ONUREG®

Placebo

Baseline
Grade 0-2
N

Post-baseline
Grade 3 or 4
n (%)

Baseline
Grade 0-2
N

Post-baseline
Grade 3 or 4
n (%)

Neutropenia

223

109 (49)

217

50 (23)

Thrombocytopenia

222

46 (21)

212

22 (10)

Anemia

229

10 (4)

223

7 (3)

Discontinuations and dose modifications in the QUAZAR® AML‑001 trial with ONUREG®1

Permanent discontinuation due to an AR occurred in 8% of patients1

ARs which resulted in permanent discontinuation in >1% of patients included:

2.1 2.1%
Nausea
1.7 1.7%
Diarrhea
1.3 1.3%
Vomiting

Treatment interruptions due to an AR occurred in 35% of patients1

ARs requiring treatment interruption in >5% of patients included:

20 20%
Neutropenia
8 8%
Thrombocytopenia
6 6%
Nausea

Dose reductions due to an AR occurred in 14% of patients1

ARs requiring dose reduction in >1% of patients included:

6 6%
Neutropenia
3.4 3.4%
Diarrhea
1.7 1.7%
Thrombocytopenia
1.7 1.7%
Nausea

Treatment duration for ONUREG® in the QUAZAR® AML-001 trial1

Patients received a median number of 12 cycles* of ONUREG®
  • 71% of patients were exposed for ≥6 months
  • 49% of patients were exposed for >1 year

*1 cycle=28 days (median).

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