Prescribing information

 

   

Whilst TAFINLAR (dabrafenib) + MEKINIST(trametinib) is likely to cause patients to experience some side effects, it has a well-established side effect profile which is generally consistent across the metastatic and adjuvant settings.1,2 By discussing the possible side effects with your patient at the beginning of treatment you will be able to help prepare them for their journey ahead.


How Can I Best Prepare Patients for Potential Side Effects?

Explain to patients that everyone’s experience of the treatment will be different and whilst side effects are likely, these can usually be managed without significant impact on their treatment.1,2 It may be helpful to remind patients that you are there to support them throughout their treatment and will help them prepare for any side effects that may arise.

Reiterate that reporting side effects is a very important part of their treatment. Patients should be encouraged to keep a record of any side effects they experience so that they can discuss these with their healthcare professional at the earliest opportunity. They can also report any side effects directly via the Yellow Card Scheme, by registering and reporting these online at www.mhra.gov.uk/yellowcard.


What Advice Could I Give to Help a Patient Manage Their Side Effects?

It may be helpful to go through some of the common side effects that patients are likely to experience. The most common side effects (incidence ≥20%) of TAFINLAR in combination with MEKINIST include pyrexia, fatigue, chills, nausea, headache, diarrhoea, vomiting, arthralgia, and rash.1,2 The occurrence of these will vary from person to person, as will the degree of severity.1,2

Alongside this, it may be helpful to explain how dose reduction or dose interruption can be used to manage side effects. If the side effects go away or reduce in intensity after dose reduction, the dose may be increased again, or kept at the new level. Reassure your patients that if there is a break in treatment, this may just be temporary and does not mean that treatment will be stopped permanently [see section on dose reduction below].1,2


What Are Dose Reduction and Dose Interruption and How Do They Impact Treatment?

Some patients may require dose reduction or dose interruption to help manage side effects.1,2 This can be a daunting prospect for patients as they may worry that reducing or stopping the dose could impact their health and treatment outcomes. Therefore, it can be reassuring to explain these concepts early on their treatment journey to help manage their treatment expectations.

Dose reduction is the temporary or permanent reduction in the prescribed quantity of treatment.1,2 If a patient is experiencing side effects, their healthcare professional may recommend taking this approach for optimal daily management. Once the side effects disappear or reduce in intensity, the dose may be increased again, or kept at the new level. Many reductions and interruptions are temporary and do not necessarily mean that treatment will be reduced or stopped indefinitely. As always, these decisions will be made under the expert guidance of their healthcare professional.


What Is Pyrexia, the Most Common Side Effect of TAFINLAR + MEKINIST?

It may be particularly helpful to discuss pyrexia (fever) with your patients treated with TAFINLAR + MEKINIST. Pyrexia, defined as a body temperature ≥38.5°C, is a common side effect that occurs with varying frequency with all approved BRAF V600 and MEK inhibitors.3,4 It is a very common side effect of TAFINLAR treatment and is more frequent when TAFINLAR is used in combination with MEKINIST.1,2

Image of pie charts detailing percentage of those treated with TAFINLAR + MEKINIST across Phase II and Phase III clinical trials:

Median time to onset of pyrexia was 27 days,3* and ~50% of first occurences are in the first month of therapy.1 In the metastatic melanoma setting, the median duration of first pyrexia event was three days (COMBI-d trial).4

What Is the Best Way to Manage Pyrexia?

Pyrexia can generally be resolved with temporary dose interruption.1,2,3 Advise patients to check their temperature if they suspect they have a fever and to let their healthcare professional know immediately if their temperature is ≥38.5°C.^

^ In the TAFINLAR + MEKINIST clinical studies, management of pyrexia was implemented at ≥38.5°C. Local treatment protocols may define pyrexia differently.

Image if icons detailing what uncomplicated pyrexia can usually be treated with

Image if icons and text detailing both advice for hcps and patients

Some patients may be receiving care from other healthcare professionals outside of oncology and in the wider multidisciplinary team, so it is important to also inform them that these patients may experience a pyrexia event.

Management of Pyrexia: Interrupt, Manage, Reinstate

The diagram below outlines the recommended approach to managing the varied grades of a pyrexia event. This information may also be useful to share with the wider multidisciplinary team responsible for an individual patient’s disease management.

Diagram detailing the recommended approach to managing the varied grades of a pyrexia event

 

TAFINLAR (dabrafenib) capsules, in combination with MEKINIST (trametinib) tablets, is indicated for:1,2

  • Adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
  • Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  • Treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

 

References

  1. TAFINLAR (dabrafenib) Summary of Product Characteristics.
  2. MEKINIST (trametinib) Summary of Product Characteristics.
  3. Robert C, et al. Presented at ESMO 2019; 27 September–1 October, Barcelona, Spain.
  4. Long GV, et al. N Engl J Med 2014; 371:1877–1888.
  5. Welsh S, Corrie P. Ther Adv Med Oncol 2015; 7:122–136.
  6. Fever, Neutropenic Fever, and their Relationship to Chemotherapy. Available at: http://chemocare.com/chemotherapy/side-effects/fever-neutropenic-fever-a.... Accessed September 2020.
  7. Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
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UK | December 2020 | 100922
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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]