INDICATIONS
Azacitidine 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.
DOSAGE AND ADMINISTRATION
Important Administration Information.
Do not substitute Azacitidine for intravenous or subcutaneous Azacitidine. The indications and dosing regimen for Azacitidine differ from that of intravenous or subcutaneous Azacitidine. Recommended Dosage The recommended dosage of Azacitidine is 300 mg orally once daily with or without food on Days 1 through 14 of each 28-day cycle. Continue Azacitidine until disease progression or unacceptable toxicity. Administer an antiemetic 30 minutes prior to each dose of Azacitidine 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 less than 0.5 Gi/L on Day 1 of a cycle, do not administer Azacitidine (Azacitidine). Delay the start of the cycle until the ANC is 0.5 Gi/L or more.
Instruct patients on the following:
• Do not split, crush, or chew Azacitidine tablets.
• Take a dose about the same time each day.
• If a dose of Azacitidine 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. Azacitidine is a hazardous drug. Follow applicable special handling and disposal procedures.
Monitoring and Dosage Modications for Adverse Reactions
Monitor complete blood count every other week for the first 2 cycles and prior to the start of each cycle thereafter. Increase monitoring to every other week for the 2 cycles after any dose reduction for myelosuppression.
