Bacrelba Dosage/Direction for Use

Treatment with Asciminib (Bacrelba) should be initiated by a physician experienced in the use of anticancer therapies.
Dosage regimen: General target population: Ph+CML-CP: The recommended total daily dose of Asciminib (Bacrelba) is 80 mg. Asciminib (Bacrelba) 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 changing from 40 mg twice daily to 80 mg once daily should start taking Asciminib (Bacrelba) once daily approximately 12 hours after the last twice-daily dose, and then continue at 80 mg once daily.
Patients changing from 80 mg once daily to 40 mg twice daily should start taking Asciminib (Bacrelba) twice daily approximately 24 hours after the last once-daily dose and then continue at 40 mg twice daily at approximately 12-hour intervals.
Any change in the dosage regimen is at the prescriber's discretion, as necessary for the management of the patient.
Ph+ CML-CP harboring the T315I mutation: The recommended dose of Asciminib (Bacrelba) is 200 mg taken orally twice daily at approximately 12-hour intervals.
Treatment with Asciminib (Bacrelba) should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Missed dose: Once-daily dosage regimen: If an Asciminib (Bacrelba) dose is missed by more than approximately 12 hours, it should be skipped, and the next dose should be taken as scheduled.
Twice-daily dosage regimens: If an Asciminib (Bacrelba) dose is missed by more than approximately 6 hours, it should be skipped, and the next dose should be taken as scheduled.
Dose modifications: Ph+ CML-CP: For the management of adverse drug reactions, Asciminib (Bacrelba) dose can be reduced based on individual safety and tolerability, as described in Table 3. If adverse drug reactions are effectively managed, Asciminib (Bacrelba) may be resumed as described in Table 3.
Asciminib (Bacrelba) should be permanently discontinued in patients unable to tolerate a total daily dose of 40 mg.
Ph+ CML-CP harboring the T315I mutation: For the management of adverse drug reactions, Asciminib (Bacrelba) dose can be reduced based on individual safety and tolerability, as described in Table 3. If adverse drug reactions are effectively managed, Asciminib (Bacrelba) may be resumed as described in Table 3.
Asciminib (Bacrelba) should be permanently discontinued in patients unable to tolerate a dose of 160 mg twice daily. (See Table 3.)

Click on icon to see table/diagram/image

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

Click on icon to see table/diagram/image

Special populations: Renal impairment: No dose adjustment is required in patients with mild, moderate, or severe renal impairment receiving Asciminib (Bacrelba). Caution should be exercised in patients with severe renal impairment receiving Asciminib (Bacrelba) 200 mg twice daily dose (see Pharmacology under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild, moderate, or severe hepatic impairment receiving Asciminib (Bacrelba). Caution should be exercised in patients with severe hepatic impairment receiving Asciminib (Bacrelba) 200 mg twice daily dose (see Pharmacology under Actions).
Pediatric patients {below 18 years): The safety and efficacy of Asciminib (Bacrelba) in pediatric patients (below 18 years) has not been established.
Geriatric patients (65 years of age or above): No dose adjustment is required in patients 65 years of age or above.
Method of administration: Asciminib (Bacrelba) should be taken orally without food. Food consumption should be avoided for at least 2 hours before and 1 hour after taking Asciminib (Bacrelba) (see Interactions and Pharmacology under Actions).
Asciminib (Bacrelba) film-coated tablets should be swallowed whole and should not be broken, crushed, or chewed.