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 > Safety > BRAF V600+ NSCLC > Safety Profile

A well-characterized safety profile1,2

TAFINLAR + MEKINIST provides clinically meaningful responses and has a demonstrated safety profile in BRAF V600+ NSCLC1-3

  • The most common adverse reactions (≥10%) were: neutropenia, hyponatremia, headache, dizziness, hemorrhage, hypotension, nausea, vomiting, diarrhea, decreased appetite, constipation, erythema, dry skin, rash, pruritus, hyperkeratosis incl. hyperkeratosis, actinic and seborrheic keratosis and keratosis pilaris, muscle spasms, arthralgia, myalgia, pyrexia, asthenia including fatigue and malaise, edema (generalized and peripheral), chills, blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased1

Adverse reactions occurring in >20% (all grades) of patients treated with TAFINLAR + MEKINIST: Cohorts B and C (N=93)2,3

Adverse reactions occurring in ≥20% (all grades) of patients treated with TAFINLAR + MEKINIST (N=93).
NR, not reported. 
aHemorrhage includes cases of hemoptysis, hematoma, epistaxis, purpura, hematuria, subarachnoid hemorrhage, gastric hemorrhage, urinary bladder hemorrhage, contusion, hematochezia, injection site hemorrhage, melaena, pulmonary and retroperitoneal hemorrhage. 

bRash includes rash, rash generalized, rash papular, rash macular, rash maculo-papular, and rash pustular. 

cAsthenia also includes fatigue and malaise.
 
dEdema includes generalized edema and peripheral edema.   
  • Pyrexia was one of the most common adverse reactions, reported by 55% of patients receiving TAFINLAR + MEKINIST  for BRAF V600+ NSCLC2,3
  • 2 patients discontinued TAFINLAR + MEKINIST  due to pyrexia4
  • 18% of patients discontinued TAFINLAR + MEKINIST  due to adverse reactions4

Safety information

References: 1. Data on file (TAF + MEK Combined BSS); Novartis Pharmaceuticals Corp; 2020. 2. Data on file (Tafinlar CDS); Novartis Pharmaceuticals Corp; 2020. 3. Data on file (Mekinist CDS); Novartis Pharmaceuticals Corp; 2020. 4. Tafinlar [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017. 

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