Leukemias, lymphomas, and other hematologic cancers:

Indications for ONUREG:

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.

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.

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).

Pharmacologic Class:

Cytidine analogue.

Adverse Reactions:

Nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, pain in extremity; lab abnormalities.

Generic Availability:

NO

How Supplied:

Tabs—14

Pricing for ONUREG

300mg tablet (Qty: 14)
Appx. price $21591
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