Source: European Medicines Agency (EU) Revision Year: 2022 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) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).
Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
The recommended dose is 40 mg twice daily at approximately 12-hour intervals.
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 40 mg twice daily, while the reduced dose is 20 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 20 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 × 109/l and/or PLT <50 × 109/l | Withhold asciminib until resolved to ANC ≥1 × 109/l and/or PLT ≥50 × 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 × 109/l and PLT ≥50 × 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 dose adjustment is required in patients with mild, moderate or severe renal impairment (see section 5.2).
No dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see section 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.
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 blisters containing 10 film-coated tablets.
The following pack sizes are available: Packs containing 20 or 60 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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