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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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Dosing and
Administration

ONUREG® offers convenient, once-daily, oral dosing that patients can take at home1

The recommended dosage of ONUREG® is one 300 mg tablet orally, once daily with or without food on Days 1-14 of each 28-day treatment cycle1

Recommended dosage1

2 weeks on, 2 weeks off 300mg on days 1-14 of each 28-day treatment cycle 2 weeks on, 2 weeks off 300mg on days 1-14 of each 28-day treatment cycle Continue ONUREG® until disease progression or unacceptable toxicity Do not substitute ONUREG® for intravenous or subcutaneous azacitidine. The indications and dosing regimen for ONUREG® differ from that of intravenous or subcutaneous azacitidine

Administration1

  • Administer an antiemetic 30 minutes prior to each dose of ONUREG® for the first 2 cycles. Antiemetic prophylaxis may be omitted after 2 cycles if there has been no nausea and vomiting
  • If the absolute neutrophil count (ANC) is <0.5 Gi/L on Day 1 of a cycle, do not administer ONUREG®. Delay the start of the cycle until the ANC is ≥0.5 Gi/L

Instruct patients on the following1:

Take a dose about the
same time each day

Do not split, crush,
or chew tablets*

  • If a dose of ONUREG® is missed, or not taken at the usual time, take the dose as soon as possible on the same day, and resume the normal schedule the following day. Do not take 2 doses on the same day
  • If a dose is vomited, do not take another dose on the same day. Resume the normal schedule the following day

*ONUREG® is a hazardous drug. Follow applicable special handling and disposal procedures. If powder comes in contact with skin, immediately and thoroughly wash with soap and water. If powder comes in contact with mucous membranes, immediately flush the area with water.

Dosage modifications for adverse reactions1

Recommended dosage modifications for ARs1

Monitor complete blood count every other week for the first 2 cycles and prior to the start of the next cycle thereafter. Increase monitoring to every other week for the 2 cycles after any dose reduction for myelosuppression.

Myelosuppression

GI Toxicity or Other ARs

Dose modifications for ONUREG® myelosuppression adverse reactions Dose modifications for ONUREG® GI toxicity or other adverse reactions
Dose modifications for ONUREG® adverse reactions

ONUREG® tablets are available in 2 strengths for once-daily, oral dosing1

ONUREG® 200mg and 300mg tablets ONUREG® 200mg and 300mg tablets

ONUREG® tablets are supplied in bottles of 14 tablets with 2 desiccant canisters.

Storage1

Tablet bottle
Store bottles

68°F to 77°F (20°C to 25°C)

  • Excursions permitted between 59°F to 86°F (15°C to 30°C) (see USP Controlled Room Temperature)
  • Keep bottle tightly closed
  • Store and dispense in the original bottle (with 2 desiccant canisters)

Handling and disposal1

ONUREG® is a hazardous drug. Follow applicable special handling and disposal procedures. If powder comes in contact with skin, immediately and thoroughly wash with soap and water. If powder comes in contact with mucous membranes, immediately flush the area with water.