Prescribing information

 

The below content is for healthcare professionals in Great Britain only. If you require information for Northern Ireland please refer to the Northern Ireland prescribing information.

 

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SCEMBLIX®▼ (asciminib) has once- or twice-daily oral dosing1

Recommended dosage in adult patients with Ph+ CML-CP, previously treated with ≥2 TKIs and without a known T315I mutation.1

80 mg QD icon

SCEMBLIX should be taken at approximately the same time every day.

If a SCEMBLIX dose is missed by more than 12 hours, advise the patient to skip the dose and take the next dose as scheduled.1

40 mg BID (am and pm) icon

SCEMBLIX should be taken twice daily at approximately 12-hour intervals.1

If a SCEMBLIX dose is missed by more than 6 hours, advise the patient to skip the dose and take the next dose as scheduled.1

For further information on changing between dosing schedules for the recommended dose of SCEMBLIX, please refer to the Summary of Product Characteristics.1

SCEMBLIX, an opportunity to manage ≥3rd-line patients with a flexible dosing schedule1

Dose modification schedule infographic

SCEMBLIX should be permanently discontinued in patients unable to tolerate a total daily dose of 40 mg.1

Since there are no data available in patients with moderate or severe hepatic impairment, caution should be exercised in these patients.1

Withholding SCEMBLIX followed by potential dose reductions and/or permanent discontinuations may be required in case of thrombocytopenia and/or neutropenia, asymptomatic amylase and/or lipase elevation and non-haematological Grade ≥3 adverse reactions. Please refer to the Summary of Product Characteristics for the detailed guidance on managing each of these adverse events and on dose modification of SCEMBLIX.1

An unmet need remains for many CML patients on ≥3rd line of therapy2

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BID, twice daily; CML, chronic myeloid leukaemia; Ph+ CML-CP, Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase; QD, once daily; TKI, tyrosine kinase inhibitor.

SCEMBLIX is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.1

For further information please refer to the Summary of Product Characteristics.

 

References

  1. SCEMBLIX (asciminib) Summary of Product Characteristics.
  2. Bosi GR, et al. Hematol Transfus Cell Ther 2019;41(3):222–228.
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UK | September 2023 | 299911

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]