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.

 

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Regular monitoring is important to assess treatment benefits and inform the decision to switch1,2

Monitoring milestones of BCR-ABL1 transcript levels by the IS (international scale) at 3, 6 and 12 months is essential to determine treatment interventions.1,2

In later lines of treatment, acceptable response cannot be formally defined, but a BCR-ABL1IS >1% is insufficient for optimal survival.1,2

Patient monitoring and management. Line graph which shows monitoring milestones using BCR-ABL1 transcript levels.

Adapted from Smith G, et al. 20202; Hochhaus A, et al. 2020.1

 

For full details on monitoring, please see the ELN 2020 Guidelines and the Scemblix SmPC.

Even after MMR is achieved, monitoring of MMR should continue every 3–6 months1,2

Make monitoring and management effective

VISIT OUR RESOURCES PAGE FOR
PATIENT SUPPORT TOOLS

CCyR, complete cytogenetic remission; EMR, early molecular response; IS, international scale; MMR, major molecular response; MR, molecular response.

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.3

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

 

References

  1. Hochhaus A, et al. Leukemia 2020;34:966–984.
  2. Smith G, et al. Br J Haematol 2020;191(2):171–193.
  3. SCEMBLIX (asciminib) Summary of Product Characteristics.
Rate this content: 
No votes yet
UK | October 2022 | 212224

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]