Scemblix Dosage/Direction for Use

Treatment with Scemblix should be initiated by a physician experienced in the use of anticancer therapies.
Usual dosage: Ph+ CML-CP: The recommended total daily dose of Scemblix is 80 mg. Scemblix can be taken orally either as 80 mg once daily at approximately the same time each day or as 40 mg twice daily at approximately 12-hour intervals.
Patients who are switched from 40 mg twice daily to 80 mg once daily should start taking Scemblix once daily approximately 12 hours after the last twice-daily dose and then continue at 80 mg once daily.
Patients who are switched from 80 mg once daily to 40 mg twice daily should start taking Scemblix twice daily approximately 24 hours after the last once-daily dose and then continue at 40 mg twice daily at approximately 12-hour intervals (see Pharmacology: Pharmacodynamics: Clinical efficacy under Actions).
Ph+ CML-CP harbouring a T315I mutation: The recommended dose of Scemblix is 200 mg taken orally twice daily at approximately 12-hour intervals.
Treatment duration: Scemblix treatment should be continued as long as a clinical benefit is observed or until unacceptable toxicity occurs.
Dose modification due to adverse effects/interactions: Ph+ CML-CP: For the management of adverse drug reactions of Scemblix, the dose can be reduced based on individual safety and tolerability as described in Table 3. If the adverse drug reactions are effectively managed, treatment with Scemblix may be resumed as described in Table 3.
Scemblix should be permanently discontinued in patients unable to tolerate a total daily dose of 40 mg.
Ph+ CML-CP harbouring a T315I mutation: For the management of adverse drug reactions of Scemblix, the dose can be reduced based on individual safety and tolerability as described in Table 3. If the adverse drug reactions are effectively managed, treatment with Scemblix may be resumed as described in Table 3.
Scemblix should be permanently discontinued in patients unable to tolerate a dose of 160 mg twice daily. (See Table 3.)

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The recommended dose modification for the management of selected adverse drug reactions is shown in Table 4. (See Table 4.)

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Patients with hepatic impairment: No dose adjustment is necessary in patients with mild, moderate or severe hepatic impairment receiving Scemblix. Caution is required in patients with severe hepatic impairment receiving Scemblix 200 mg twice daily (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: No dose adjustment is necessary in patients with mild, moderate or severe renal impairment receiving Scemblix. Caution is required in patients with severe renal impairment receiving Scemblix 200 mg twice daily (see Pharmacology: Pharmacokinetics under Actions).
Elderly patients: No dose adjustment is required in patients 65 years of age and over.
Children and adolescents: The safety and efficacy in patients under 18 years of age have not been established.
Late administration: Once-daily dosage regimen: If a dose of Scemblix is more than approx. 12 hours late, it should be skipped and the next one taken as scheduled.
Twice-daily dosage regimen: If a dose of Scemblix is more than approx. 6 hours late, it should be skipped and the next one taken as scheduled.
Method of administration: Scemblix should be taken orally without food. The intake of food should be avoided for at least 2 hours before and 1 hour after taking Scemblix (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Scemblix film-coated tablets must be swallowed whole with a glass of water and should not be broken, crushed or chewed.