Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) (see section 5.1).
Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).
Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
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 (see section 4.4).
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.
The recommended dose is 200 mg twice daily at approximately 12-hour intervals.
Use of the 100 mg film-coated tablets is restricted to patients with Ph+ CML-CP with the T315I mutation.
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 Table 1. Asciminib should be permanently discontinued in patients unable to tolerate a dose of 40 mg once daily or 20 mg twice daily.
The starting dose is 200 mg twice daily, while the reduced dose is 160 mg twice daily. The dose can be modified based on individual safety and tolerability as shown in Table 1. Asciminib should be permanently discontinued in patients unable to tolerate a dose of 160 mg twice daily.
Table 1. 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.
No dose adjustment is required in patients aged 65 years or above.
No starting dose adjustment is required in patients with mild or moderate renal impairment at all recommended doses and in patients with severe renal impairment at the 80 mg total daily dose. No clinical data are available in patients with severe renal impairment at the 200 mg asciminib twice daily dose. Therefore, no recommendations for dose adjustment can be given. Caution should be exercisedin patients with severe renal impairment receiving the 200 mg twice daily dose (see sections 4.4 and 5.2).
No starting dose adjustment is required in patients with mild or moderate hepatic impairment at all recommended doses and in patients with severe hepatic impairment at the 80 mg total daily dose. No clinical data are available in patients with severe hepatic impairment at the 200 mg asciminib twice daily dose. Therefore, no recommendations for dose adjustment can be given. Caution should be exercised in patients with severe hepatic impairment receiving the 200 mg twice daily dose (see sections 4.4 and 5.2).
The safety and efficacy of Scemblix in paediatric patients aged below 18 years have not been established. No data are available.
Scemblix is for oral use. The film-coated 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 (see section 5.2).
In clinical studies, asciminib has been administered at doses up to 280 mg twice daily with no evidence of increased toxicity.
General supportive measures and symptomatic treatment should be initiated in cases of suspected overdose.
Scemblix 20 mg and 40 mg film-coated tablets:
3 years.
Scemblix 100 mg film-coated tablets:
2 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Scemblix is supplied in PCTFE/PVC/alu (20 mg and 40 mg film-coated tablets) or PA/alu/PVC/alu
(100 mg film-coated tablets) blisters containing 10 film-coated tablets.
The following pack sizes are available:
Scemblix 20 mg film-coated tablets:
Packs containing 20 or 60 film-coated tablets.
Scemblix 40 mg film-coated tablets:
Packs containing 20 or 60 film-coated tablets.
Multipacks containing 180 (3 packs of 60) film-coated tablets.
Scemblix 100 mg film-coated tablets:
Packs containing 60 or 120 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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