For Healthcare Professionals Outside the US
Tafinlar + Mekinist is indicated for adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection; for first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation; for adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

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Home > Dosing > Dose-reductions

Adverse reactions may be managed with dose modifications1,2

  • If treatment-related toxicities occur with TAFINLAR + MEKINIST, then the doses of both treatments should be simultaneously reduced, interrupted, or discontinued in most cases1,2
  • Dose reduction of TAFINLAR only or MEKINIST only is recommended for management of certain adverse reactions1,2
  • Dose modifications or interruptions are not recommended for cutaneous squamous cell carcinoma or new primary melanoma1,2
  • Refer to the TAFINLAR and MEKINIST summaries of product characteristics (SmPCs) for additional information on adverse reaction management1,2

Dose modification schedule based on the grade of any adverse reaction

  Treatment Modification

Grade 1 or grade 2 (tolerable)

Continue treatment and monitor as clinically indicated

Grade 2 (intolerable) or grade 3

Interrupt therapy until toxicity is grade 0-1 and reduce by 1 dose level when therapy is resumed

Grade 4

Discontinue permanently or interrupt until toxicity is grade 0-1 and reduce by 1 dose level  when therapy is resumed

 

The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Event v4.0
Dose modification schedule for Tafinlar and Mekinist.
Dose modification schedule for Tafinlar and Mekinist.
Monotherapy or in combination with MEKINIST.
In combination with TAFINLAR.
References: 1. TAFINLAR Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 2. MEKINIST Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020.

COVID-19 Update


Novartis is closely monitoring the evolving COVID-19 pandemic. For the most recent information on how Novartis is responding, visit the COVID-19 Information Center.

During this time of uncertainty it is important to communicate with your patients about COVID-19 to clarify that they should not stop their treatments except under the direction of the treating physician, and to ensure that patients have sufficient drug to avoid any treatment interruptions.

Reach out to your Novartis representative with any questions related to Novartis products.

04/20  G-ONC-1230566

COMBI-AD was a double-blind, placebo-controlled, Phase 3 trial that compared Tafinlar + Mekinist vs placebo4

ELIGIBILITY REQUIREMENTS

  • Resection of histologically confirmed Stage IIIA, B, or C with BRAF V600E or BRAF V600K mutation
  • ECOG performance status ≤1
  • No prior systemic anticancer treatment or radiotherapy for melanoma
TAFINLAR 150 mg BID + MEKINIST
2 mg QD (n=438)
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Placebo (n=432)

STUDY ENDPOINTS

  • Primary endpoint was RFS
  • Secondary endpoints were OS, distant metastasis-free survival, freedom from relapse, and safety
COMBI-d phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs Tafinlar® monotherapy