Prescribing information

 

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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
Image of a digital thermometer.
 

Three-step guidance for managing pyrexia (≥38°C)1–3

1. Interrupt 2. Manage 3. Restart
  • Interrupt Tafinlar and Mekinist
  • Evaluate for infection, and, if necessary, treat in accordance with local practice
  • Initiate antipyretics such as ibuprofen or paracetamol
  • Consider oral corticosteroids in instances in which antipyretics are insufficient

If the patient is symptom free for at least 24 hours, restart Taflinar and Mekinist either:

  • At the same dosage

OR

  • At a reduced dosage if the pyrexia was recurrent and/or was accompanied by other severe signs and symptoms

Advice for Healthcare Professionals and Patients

Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Advice for Healthcare Professionals

Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Rule out infective cause

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Check blood pressure and carry out a full blood count to rule out neutropenia

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

If antifungal or antibiotic therapy is required, please refer to the Summary of Product Characteristics, as some products may interact with Tafinlar

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Some patients may also have hypotension or general malaise and need to be hospitalised

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Advice for
Your Patients

Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

Drink plenty of non-alcoholic and caffeine-free fluids to prevent dehydration

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

A lukewarm bath, an ice pack or cool, moist flannel on the forehead or back of the neck can make you feel more comfortable

 
Ten mini icons - doctor, patient, germs, glass of water, blood cells under magnifying glass, bath, document, thermometer, hospital, safety cross.

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.

GB & NI SmPC for Tafinlar

GB SmPC for Mekinist

NI SmPC for Mekinist

GB & NI PIL for Tafinlar

GB PIL for Mekinist

NI PIL for Mekinist

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

  1. Tafinlar (dabrafenib) Summary of Product Characteristics. Great Britain and Northern Ireland.
  2. Mekinist (trametinib) Summary of Product Characteristics. Great Britain.
  3. Mekinist (trametinib) Summary of Product Characteristics. Northern Ireland.
  4. Planchard D, et al. Lancet Oncol 2017;18:1307–1316.
  5. Planchard D, et al. ASCO virtual meeting, May 29–31, 2020.
  6. Long GV, et al. N Engl J Med 2017;377:1813–1823.
  7. Robert C, et al. N Engl J Med 2019;381:626–636.
  8. Robert C, et al. N Engl J Med 2015;372:30–39.
  9. Planchard D, et al. J Thorac Oncol 2021;Aug 26:S1556-0864(21)02403-5.
  10. 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].
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UK | November 2021 | 118705-1
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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]