Scemblix Dosage

​2.1 Recommended Dosage in Patients with Newly Diagnosed or Previously Treated Ph+ CML-CP

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

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

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

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

2.3 Missed Dose

Once Daily Dosage Regimen: If a SCEMBLIX 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 SCEMBLIX dose is missed by more than approximately 6 hours, skip the dose and take the next dose as scheduled.

2.4 Dosage Modifications

Dosage Modifications for Patients with Newly Diagnosed or Previously Treated Ph+ CML-CP

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

The recommended dosage modifications for the management of selected adverse reactions are shown in Table 2.

2.5 Administration

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