Dosage of Asciminib

1.Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs 

The recommended dose of Asciminib is 80 mg taken orally once daily at approximately the same time each day or 40 mg twice daily at approximately 12-hour intervals. The recommended dose of Asciminib is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking Asciminib.. 

Continue treatment with Asciminib as long as clinical benefit is observed or until unacceptable toxicity occurs. 

2.Recommended Dosage in Patients with Ph+ CML-CP with the T315I Mutation 

The recommended dose of Asciminib is 200 mg taken orally twice daily at approximately 12-hour intervals. The recommended dose of Asciminib is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking Asciminib. 

3.Missed Dose 

Once Daily Dosage Regimen: If a Asciminib dose is missed by more than approximately 12 hours, skip the dose and take the next dose as scheduled. 

Twice Daily Dosage Regimens: If a Asciminib dose is missed by more than approximately 6 hours, skip the dose and take the next dose as scheduled. 

4.Dosage Modifications 

Dosage Modifications for Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs

 For the management of adverse reactions, reduce the Asciminib dose as described in Table 1.

 Dosage Modifications for Patients with Ph+ CML-CP with the T315I Mutation

 For the management of adverse reactions, reduce the Asciminib dose as described in Table 1.

5.Administration 

Advise patients to swallow Asciminib tablets whole. Do not break, crush, or chew the tablets. 

from FDA,2021.10