Podcast with Dr. Salaroli about the 4-year results of the ASCEMBL study comparing asciminib with bosutinib for patients with chronic myeloid leukaemia in chronic phase

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BE2312205636 20/12/23

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Name: Scemblix 20 mg/40 mg film-coated tablets Composition: Scemblix 20 mg film-coated tablets: Each film-coated tablet contains 21.62 mg asciminib hydrochloride, equivalent to 20 mg asciminib. Excipient with known effect: Each film-coated tablet contains 43 mg lactose monohydrate. Scemblix 40 mg film-coated tablets: Each film-coated tablet contains 43.24 mg asciminib hydrochloride, equivalent to 40 mg asciminib. Excipient with known effect: Each film-coated tablet contains 86 mg lactose monohydrate. For the full list of excipients, see full leaflet. Pharmaceutical form: Film-coated tablet (tablet). Scemblix 20 mg film-coated tablets: Pale yellow, round, biconvex film-coated tablets with bevelled edges of approximately 6 mm diameter, debossed with company logo on one side and “20” on the other side. Scemblix 40 mg film-coated tablets: Violet white, round, biconvex film-coated tablets with bevelled edges of approximately 8 mm diameter, debossed with company logo on one side and “40” on the other side. Therapeutic indications: 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 full leaflet). Posology: 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. Missed dose: 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 duration: Treatment with asciminib should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. Dose adjustments for adverse reactions: 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 (see full leaflet). Asciminib should be permanently discontinued in patients unable to tolerate a dose of 20 mg twice daily. Special populations: Elderly: No dose adjustment is required in patients aged 65 years or above. Renal impairment: No dose adjustment is required in patients with mild, moderate or severe renal impairment (see full leaflet). Hepatic impairment: No dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see full leaflet). Paediatric population: The safety and efficacy of Scemblix in paediatric patients aged below 18 years have not been established. No data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the full leaflet. Undesirable effects: Summary of the safety profile: The most common adverse reactions of any grade (incidence ≥20%) in patients receiving asciminib were musculoskeletal pain (37.1%), upper respiratory tract infections (28.1%), thrombocytopenia (27.5%), fatigue (27.2%), headache (24.2%), arthralgia (21.6%), increased pancreatic enzymes (21.3%), abdominal pain (21.3%), diarrhoea (20.5%) and nausea (20.2%). The most common adverse reactions of ≥ grade 3 (incidence ≥5%) in patients receiving asciminib were thrombocytopenia (18.5%), neutropenia (15.7%), increased pancreatic enzymes (12.4%), hypertension (8.7%) and anaemia (5.3%). Serious adverse reactions occurred in 12.4% of patients receiving asciminib. The most frequent serious adverse reactions (incidence ≥1%) were pleural effusion (2.5%), lower respiratory tract infections (2.2%), thrombocytopenia (1.7%), pyrexia (1.4%), pancreatitis (1.1%), non-cardiac chest pain (1.1%) and vomiting (1.1%). Tabulated list of adverse reactions: The overall safety profile of asciminib has been evaluated in 356 patients with Ph+ CML in chronic (CP) and accelerated (AP) phases in the pivotal phase III study A2301 (ASCEMBL) and the phase I study X2101. In ASCEMBL, patients received asciminib as monotherapy at a dose of 40 mg twice daily. In X2101, patients received asciminib as monotherapy at doses ranging from 10 to 200 mg twice daily and 80 to 200 mg once daily. In the pooled dataset, the median duration of exposure to asciminib was 116 weeks (range: 0.1 to 342 weeks). Adverse reactions from clinical studies (Table 2, see full leaflet) are listed by MedDRA system organ class. Description of selected adverse reactions: see full leaflet. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. Marketing authorisation holder and numbers: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland. EU/1/22/1670/001-005 Delivery: Medicinal product subject to prescription. Date of revision of the text: 24.07.2023. Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.