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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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ONUREG® (oral azacitidine) has an established safety and tolerability profile1

In QUAZAR AML-001

The majority of ONUREG® adverse reactions
were mild to moderate (Grade 1 or 2)1

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

Table detailing rates of adverse reactions for ONUREG® and placebo patients in the QUAZAR AML-001 trial. Table detailing rates of adverse reactions for ONUREG® and placebo patients in the QUAZAR AML-001 trial.

In QUAZAR AML-001

Hematologic adverse reactions were observed1

Select hematological laboratory abnormalities that worsened from baseline in patients who received ONUREG®1

Table detailing number of ONUREG® and placebo patients who experienced hematological abnormalities during the QUAZAR AML-001 trial. Table detailing number of ONUREG® and placebo patients who experienced hematological abnormalities during the QUAZAR AML-001 trial.
  • A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively1
  • Less than 1% of patients discontinued ONUREG® due to either neutropenia or thrombocytopenia1
Recommendations for managing myelosuppression Recommendations for managing myelosuppression

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.

AR, adverse reaction; CBC, complete blood count, GI, gastrointestinal.

In QUAZAR® AML-001

Most adverse reactions were manageable with treatment interruptions or dose reductions1

Permanent discontinuation due to an adverse reaction was 8%

Rates of treatment interruption, dose reduction, and discontinuation in the QUAZAR AML‑001 trial with ONUREG® Rates of treatment interruption, dose reduction, and discontinuation in the QUAZAR AML‑001 trial with ONUREG®

Patients treated with ONUREG completed a median of 12 cycles (range: 1–82 cycles) and a mean of 19 cycles1,3,e

aARs requiring treatment interruption in >5% of patients included: neutropenia (20%), thrombocytopenia (8%), and nausea (6%).1
bARs requiring dose reductions in >1% of patients included: neutropenia (6%), diarrhea (3.4%), thrombocytopenia (1.7%), and nausea (1.7%).1
cARs resulting in permanent discontinuation in >1% of patients included: nausea (2.1%), diarrhea (1.7%), and vomiting (1.3%).1
dFor at least the first 2 cycles.1
e1 cycle=28 days.

AR, adverse reaction.

Based on the frequency of GI ARs in QUAZAR AML-001

Patients should receive prophylactic antiemetics1,2,4,a,b

Most common GI adverse reactions in the QUAZAR AML‑001 trial with ONUREG Most common GI adverse reactions in the QUAZAR AML‑001 trial with ONUREG

GI supportive care, including antiemetics and anti-diarrheals, was used to treat GI toxicity.

aRates of nausea, vomiting and diarrhea decreased after Cycles 1-2 and remained low, but fluctuated up and down, over subsequent cycles.2,4
bTEAEs include adverse events that started between first dose date and the date 28 days after the last dose date of study treatment.2 Percentage is based on the number of subjects who were exposed to investigational product at the beginning of each cycle category for the treatment group.4 A subject with multiple occurrences of a TEAE was counted only once in each cycle category.2

AR, adverse reaction; GI, gastrointestinal; TEAE, treatment-emergent adverse event.

Denise has been taking ONUREG (oral azacitidine) at home for 18 months

How do you discuss the importance of prophylactic antiemetics when prescribing ONUREG for a patient like Denise?

Denise’s treatment journey on ONUREG® Denise’s treatment journey on ONUREG® Denise is taking ONUREG with prophylactic antiemetics, and is looking forward to Thanksgiving with her family Denise is taking ONUREG with prophylactic antiemetics, and is looking forward to Thanksgiving with her family

aAll patients should receive antiemetics for at least the first 2 cycles; antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting.1

AML, acute myeloid leukemia; CBC, complete blood count, ECOG PS, Eastern Cooperative Oncology Group performance status; GI, gastrointestinal.

Review ONUREG Dosing Recommendations

INDICATION

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONUREG® is contraindicated in patients with known severe hypersensitivity to azacitidine or its components.

WARNINGS AND PRECAUTIONS

Risks of Substitution with Other Azacitidine Products

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 with ONUREG® at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute ONUREG® for intravenous or subcutaneous azacitidine.

Myelosuppression

New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG®. Febrile neutropenia occurred in 12%. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia. Less than 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 Syndromes (MDS)

In AZA-MDS-003, 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to MDS were randomized to ONUREG® or placebo. 107 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 the ONUREG® arm compared with placebo. The most frequent fatal adverse reaction was sepsis. Safety and effectiveness of ONUREG® for MDS have not been established. Treatment of MDS with ONUREG® is not recommended outside of controlled trials.

Embryo-Fetal Toxicity

ONUREG® can cause fetal harm when administered to a pregnant woman. Azacitidine caused fetal death and anomalies in pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m2 basis. 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.

ADVERSE REACTIONS

Serious adverse reactions occurred in 15% of patients who received ONUREG®. Serious adverse reactions in ≥2% included pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received ONUREG®.

Most common (≥10%) adverse reactions with ONUREG® vs placebo were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%), fatigue/asthenia (44%, 25%), constipation (39%, 24%), pneumonia (27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%), pain in extremity (11%, 5%).

LACTATION

There are no data regarding the presence of azacitidine in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONUREG® and for 1 week after the last dose.

Please see full Prescribing Information for ONUREG®.

References:
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