Miscellaneous antineoplastics
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Onureg Dosage

Drug Detail:Onureg (Azacitidine [ ay-za-sye-ti-deen ])

Generic Name: AZACITIDINE 200mg

Dosage Form: tablet, film coated

Drug Class: Miscellaneous antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Important Administration Information

Do not substitute ONUREG for intravenous or subcutaneous azacitidine. The indications and dosing regimen for ONUREG differ from that of intravenous or subcutaneous azacitidine [see Warnings and Precautions (5.1)].

Recommended Dosage

The recommended dosage of ONUREG is 300 mg orally once daily with or without food on Days 1 through 14 of each 28-day cycle. Continue ONUREG until disease progression or unacceptable toxicity.

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 less than 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 or more.

Instruct patients on the following:

•
Swallow tablets whole. Do not cut, crush, or chew the tablets.
•
Take a dose about the same time each day.
•
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.1

Monitoring and Dosage Modifications 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.

The recommended dosage modifications for adverse reactions are provided in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity Recommended Dosage Modification

Myelosuppression [see Warnings and Precautions (5.2)]

Neutrophils less than 0.5 Gi/L on Cycle Day 1
•
Interrupt treatment. Resume at the same dose once neutrophils return to 0.5 Gi/L or higher.

Neutrophils less than 1 Gi/L with fever at anytime

First Occurrence

•
Interrupt treatment. Resume at the same dose once neutrophils return to 1 Gi/L or higher.

Occurrence in 2 Consecutive Cycles

•
Interrupt treatment. After neutrophils return to 1 Gi/L or higher, resume at reduced dose of 200 mg.
•
If a patient continues to experience febrile neutropenia after dose reduction, reduce the treatment duration by 7 days.
•
If febrile neutropenia reoccurs after dose and schedule reduction, discontinue ONUREG.

Platelets less than 50 Gi/L with bleeding

First Occurrence

•
Interrupt dose. Resume at the same dose once platelets return to 50 Gi/L or higher.

Occurrence in 2 Consecutive Cycles

•
Interrupt dose. After platelets return to 50 Gi/L or higher, resume at reduced dose of 200 mg.
•
If a patient continues to experience thrombocytopenia with bleeding after dose reduction, reduce the treatment duration by 7 days.
•
If thrombocytopenia with bleeding reoccurs after dose and schedule reduction, discontinue ONUREG.

Gastrointestinal Toxicity [see Adverse Reactions (6.1)]

Grade 3 or 4 Nausea or Vomiting
•
Interrupt dose. Resume at the same dose once toxicity has resolved to Grade 1 or lower.
•
If toxicity reoccurs, interrupt dose until resolved to Grade 1 or lower. Resume at reduced dose of 200 mg.
•
If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days.
•
If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG.

Grade 3 or 4 Diarrhea
•
Interrupt dose. Resume at the same dose once toxicity has resolved to Grade 1 or lower.
•
If toxicity reoccurs, interrupt dose until resolved to Grade 1 or lower. Resume at reduced dose of 200 mg.
•
If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days.
•
If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG.

Other Adverse Reactions [see Adverse Reactions (6.1)]

Grade 3 or 4
•
Interrupt dose and provide medical support. Resume at the same dose once toxicity has resolved to Grade 1 or lower.
•
If toxicity re-occurs, interrupt dose until resolved to Grade 1 or lower. Resume at reduced dose of 200 mg.
•
If a patient continues to experience the toxicity after dose reduction, reduce the treatment duration by 7 days.
•
If the toxicity continues or reoccurs after dose and schedule reduction, discontinue ONUREG.
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