Onureg Generic Name & Formulations
Legal Class
Rx
General Description
Azacitidine 200mg, 300mg; tabs.
Pharmacological Class
Cytidine analogue.
How Supplied
Tabs—14
Manufacturer
Generic Availability
NO
Onureg Indications
Indications
Continued treatment of adults 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.
Onureg Dosage and Administration
Adult
Premedicate with antiemetic 30mins prior to each dose for the first 2 cycles. Swallow whole. 300mg once daily on Days 1–14 of each 28-day cycle. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Onureg Contraindications
Not Applicable
Onureg Boxed Warnings
Not Applicable
Onureg Warnings/Precautions
Warnings/Precautions
Do not substitute for IV or SC azacitidine. Not recommended for treating myelodysplastic syndromes. Myelosuppression. Monitor CBCs every other week for the first 2 cycles and prior to each cycle thereafter; increase monitoring after any dose reduction for myelosuppression. Do not administer if ANC <0.5Gi/L on Day 1 of a cycle; delay initiation until ANC ≥0.5Gi/L. Severe renal impairment (CrCl 15–29mL/min): monitor frequently and adjust dose as needed. Pre-existing severe hepatic impairment (total bilirubin >3×ULN). Embryo-fetal toxicity. Advise to use effective contraception during and for ≥6 months (females of reproductive potential) or ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Onureg Pharmacokinetics
See Literature
Onureg Interactions
Not Applicable
Onureg Adverse Reactions
Adverse Reactions
Nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, pain in extremity; lab abnormalities.
Onureg Clinical Trials
See Literature
Onureg Note
Not Applicable
Onureg Patient Counseling
See Literature