Scemblix Dosage/Direction for Use

Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs: 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 [see Pharmacology: Pharmacodynamics under Actions].
Continue treatment with SCEMBLIX as long as clinical benefit is observed or until unacceptable toxicity occurs.
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 [see Pharmacology: Pharmacodynamics under Actions)].
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.
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 SCEMBLIX dose as described in Table 3.
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 3. (See Table 3.)

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The recommended dosage modifications for the management of selected adverse reactions are shown in Table 4. (See Table 4.)

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