Active Ingredient: Asciminib
Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A :
Oral, 80 milligrams asciminib, once daily.
Regimen B :
Oral, 40 milligrams asciminib, once every 12 hours.
The recommended total daily dose of asciminib is 80 mg. Asciminib 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 switching from 40 mg twice daily to 80 mg once daily should start taking asciminib once daily approximately 12 hours after the last twice-daily dose, and then continue at 80 mg once daily.
Patients switching from 80 mg once daily to 40 mg twice daily should start taking asciminib twice daily approximately 24 hours after the last once-daily dose, and then continue at 40 mg twice daily at approximately 12-hour intervals.
The decision on the appropriate dosage regimen should be taken at the prescriber's discretion as necessary for the benefit of the patient.
If a dose is missed by less than 12 hours, it should be taken and the next dose should be taken as scheduled.
If a dose is missed by more than approximately 12 hours, it should be skipped and the next dose should be taken as scheduled.
If a dose is missed by less than 6 hours, it should be taken and the next dose should be taken as scheduled.
If a dose is missed by more than approximately 6 hours, it should be skipped and the next dose should be taken as scheduled.
Treatment with asciminib should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
The starting dose is 80 mg once daily or 40 mg twice daily, while the reduced dose is 40 mg once daily or 20 mg twice daily, respectively. The dose can be modified based on individual safety and tolerability as shown in the table below. Asciminib should be permanently discontinued in patients unable to tolerate a dose of 40 mg once daily or 20 mg twice daily.
Asciminib dose modification schedule for the management of adverse reactions:
| Adverse reaction | Dose modification |
| Thrombocytopenia and/or neutropenia | |
| ANC <1.0 x 109/l and/or PLT <50 x 109/l | Withhold asciminib until resolved to ANC ≥1 x 109/l and/or PLT ≥50 x 109/l. If resolved: • Within 2 weeks: resume at starting dose. • After more than 2 weeks: resume at reduced dose. For recurrent severe thrombocytopenia and/or neutropenia, withhold asciminib until resolved to ANC ≥1 x 109/l and PLT ≥50 x 109/l, then resume at reduced dose. |
| Asymptomatic amylase and/or lipase elevation | |
| Elevation >2.0 x ULN | Withhold asciminib until resolved to <1.5 x ULN. • If resolved: resume at reduced dose. If events reoccur at reduced dose, permanently discontinue. • If not resolved: permanently discontinue. Perform diagnostic tests to exclude pancreatitis. |
| Non-haematological adverse reactions | |
| Grade 3 or higher1 adverse reactions | Withhold asciminib until resolved to grade 1 or lower. • If resolved: resume at a reduced dose. • If not resolved: permanently discontinue. |
ANC: absolute neutrophil count; PLT: platelets; ULN: upper limit of normal
1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
The asciminib tablets should be swallowed whole with a glass of water and should not be broken, crushed or chewed.
The tablets should be taken orally without food. Food consumption should be avoided for at least 2 hours before and 1 hour after taking asciminib.
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