1. Medicines
  2. Oncology
  3. TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)
  4. Metastatic treatment – Safety profile

Prescribing information

 

Metastatic treatment – Safety profile

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Tafinlar (dabrafenib) + Mekinist (trametinib) is associated with an established adverse event profile, and no new safety signals were identified at 5 years1–11

  • No new safety signals were seen at 5 years in the COMBI-v/d pooled analysis2
  • No treatment-related deaths were reported in this 5 year pooled analysis2

Adverse events observed in the combined COMBI-v/d trials3

 

Table showing adverse events observed in the combined COMBI-v/d trials

 

  • In a separate pooled analysis of the COMBI-v/d trials, adverse event incidence decreased over time in patients completing 36 months of treatment (n=50)1
  • The incidence of pyrexia more than halved from 60% at 0–6 months to 12% at 30–36 months of treatment1

Adverse event incidence rates in the combined COMBI-v/d trials1

Graph showing the adverse event incidence rates in the combined COMBI-v/d trials

 

Please consult Tafinlar and Mekinist SmPCs for full list of adverse events

SmPC for Tafinlar 

SmPC for Mekinist 

 

AE, adverse event; SmPC, Summary of Product Characteristics.

References

  1. Grob JJ et al. Presented at SMR 2016; 6–9 November, Boston, MA, USA.
  2. Robert C et al. N Engl J Med 2019;381:626–636.
  3. Robert C et al. N Engl J Med 2019;381:626–636. Supplementary Table S9.
  4. Robert C et al. Presented at ESMO 2016; 7–11 October, Copenhagen, Denmark.
  5. Robert C et al. N Engl J Med 2015;372:30–39.
  6. Long GV et al. Presented at ASCO 2015; 29 May–2 June, Chicago, IL, USA. J Clin Oncol 2015;33(Suppl):Abstract no.102.
  7. Long GV et al. Ann Oncol 2017;28:1631–1639. Supplementary Table S3.
  8. Flaherty KT et al. Presented at 2016 ASCO Annual Meeting: 3–7 June, Chicago, IL, USA.
  9. Long GV et al. Lancet 2015;386:444–451.
  10. Welsh SJ and Corrie PG. Ther Adv Med Oncol 2015; 7: 122–136.
  11. Tafinlar (dabrafenib) Summary of Product Characteristics.
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TMC20-C004d May 2020.
Oncology
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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.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]