Prescribing information



Tafinlar (dabrafenib) + Mekinist (trametinib) in the adjuvant setting showed a long-term adverse event profile consistent with the metastatic setting1


  • 321 out of 435 patients (74%) in the combination arm completed 12 months of therapy1
  • Less than one third of the patients discontinued treatment because of an adverse event1
  • The peak onset of all AEs occurring in ≥15% of patients in the Tafinlar + Mekinist arm occurred within the first 3 months of treatment2
  • Frequencies of dose reductions or dose interruptions decreased as duration of treatment increased2

AE safety data from the COMBI-AD trial1,3

In the adjuvant treatment of patients with Stage III melanoma, following complete resection:

  • 95% of pyrexia was grade 1 or 21
  • Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care4

Common AEs (>20%) from the COMBI-AD trial1


AE, adverse event; SAE, serious adverse event.


  1. Long GV et al. N Engl J Med 2017;377:1813–1823.
  2. Atkinson V et al. Presented at ESMO 2018; 19–23 October, Munich, Germany.
  3. Hauschild A et al.  Presented at ESMO 2017 ; 08-12 September, Madrid, Spain.
  4. Tafinlar (dabrafenib) Summary of Product Characteristics.
TMC20-C004g May 2020

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