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
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 of each 28-day treatment cycle and prior to the start of the next cycle thereafter. Increase monitoring to every other week for the 2 cycles of each 28-day treatment cycle after any dose reduction for myelosuppression.
Myelosuppression
GI Toxicity or Other ARs
ONUREG® tablets are supplied in bottles of 14 bottles of 14 tablets (with 2 desiccant canisters) or in a blister card containing 7 tablets.1
ONUREG® tablets are supplied in bottles of 14 tablets (with 2 desiccant canisters) or in a blister card containing 7 tablets.
Storage1
Store at 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) or in the original aluminum blisters
- Blister cards will be replacing ONUREG® bottle packaging. Blister cards are provided in 7-count packages to provide flexibility in dispensing the recommended dosage and dosage modifications for adverse reactions
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.