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Tafinlar + Mekinist has a well-established safety profile1–9
The safety profile of Tafinlar + Mekinist in patients with BRAF V600-positive NSCLC is generally manageable and similar to that observed in patients with BRAF V600-positive metastatic melanoma.6–9
All-causality adverse events occurring in 20% of patients with BRAF V600E-positive NSCLC10
| Adverse event, n (%) | Any grade | Grade 3 | Grade 4 |
|---|---|---|---|
| Pyrexia | 52 (56) | 6 (6) | 0 |
| Nausea | 47 (51) | 0 | 0 |
| Vomiting | 38 (41) | 3 (3) | 0 |
| Dry skin | 36 (39) | 1 (1) | 0 |
| Peripheral oedema | 35 (38) | 0 | 0 |
| Diarrhoea | 34 (37) | 2 (2) | 0 |
| Decreased appetite | 31 (33) | 0 | 0 |
| Cough | 29 (31) | 0 | 0 |
| Asthenia | 27 (29) | 4 (4) | 0 |
| Fatigue | 27 (29) | 3 (3) | 0 |
| Rash | 27 (29) | 2 (2) | 0 |
| Dyspnoea | 26 (28) | 7 (8) | 0 |
| Arthralgia | 25 (27) | 1 (1) | 0 |
| Chills | 25 (27) | 0 | 0 |
Table adapted from Planchard D, et al. 2021.
Data cut-off: February 24, 2021.9
- Across clinical trials, pyrexia was the most common adverse event observed in patients treated with Tafinlar + Mekinist.1–9
- Most pyrexia events were mild or moderate (Grade 1/2).5,6,10
- Therapy with Tafinlar and Mekinist should be interrupted if the patient's temperate is ≥38°C.
- In case of recurrence, therapy can also be interrupted at the first symptom of pyrexia.
- Patients may respond well to dose interruption and/or dose reduction and supportive care for the management of pyrexia, allowing re-initiation of treatment.1–3
Three-step guidance for managing pyrexia (≥38°C)1–3
| 1. Interrupt | 2. Manage | 3. Restart |
|---|---|---|
|
|
If the patient is symptom free for at least 24 hours, restart Taflinar and Mekinist either:
OR
|
Advice for Healthcare Professionals and Patients
Advice for Healthcare Professionals
Rule out infective cause
Check blood pressure and carry out a full blood count to rule out neutropenia
If antifungal or antibiotic therapy is required, please refer to the Summary of Product Characteristics, as some products may interact with Tafinlar
Some patients may also have hypotension or general malaise and need to be hospitalised
Advice for
Your Patients
Drink plenty of non-alcoholic and caffeine-free fluids to prevent dehydration
A lukewarm bath, an ice pack or cool, moist flannel on the forehead or back of the neck can make you feel more comfortable
Take appropriate medication as prescribed to control your fever
In case of hospitalisation due to pyrexia, inform the healthcare professional treating you that you are on Tafinlar + Mekinist, which causes pyrexia as a common side effect
Accompanying symptoms: pyrexia may be accompanied by severe rigors, dehydration, and hypotension which in some cases can lead to acute renal insufficiency
For more information on Tafinlar + Mekinist please refer to the Summary of Product Characteristics and Patient Information Leaflets. Please also refer to the Summary of Product Characteristics for management of other adverse events.
NSCLC, non-small cell lung cancer; V600E, mutation of the BRAF gene in which valine (V) is substituted by glutamic acid (E) at amino acid 600.
References
- Tafinlar (dabrafenib) Summary of Product Characteristics. Great Britain and Northern Ireland.
- Mekinist (trametinib) Summary of Product Characteristics. Great Britain.
- Mekinist (trametinib) Summary of Product Characteristics. Northern Ireland.
- Planchard D, et al. Lancet Oncol 2017;18:1307–1316.
- Planchard D, et al. ASCO virtual meeting, May 29–31, 2020.
- Long GV, et al. N Engl J Med 2017;377:1813–1823.
- Robert C, et al. N Engl J Med 2019;381:626–636.
- Robert C, et al. N Engl J Med 2015;372:30–39.
- Planchard D, et al. J Thorac Oncol 2021;Aug 26:S1556-0864(21)02403-5.
- Planchard D, et al. Supplementary Table 4 for Planchard D, et al. J Thorac Oncol 2021 Aug 26:S1556-0864(21)02403-5. Available at: https://www.jto.org/article/S1556-0864(21)02403-5/fulltext#appsec1. [Accessed October 2021].
