Prescribing information

 

Patients who have been prescribed TAFINLAR (dabrafenib) + MEKINIST (trametinib) combination therapy, and those who support them, may have questions about their treatment journey and how this could impact their daily lives. The following information may be helpful in your discussions with patients and those close to them.


Why Is TAFINLAR + MEKINIST Used to Treat Melanoma?

TAFINLAR + MEKINIST is a targeted therapy, designed to ‘switch off’ uncontrolled signalling in cancer cells. In patients who have a mutated BRAF gene, uncontrolled signalling in the MAP kinase pathway can cause melanoma cells to grow and spread. TAFINLAR + MEKINIST inhibit two types of enzymes in the MAP kinase pathway, mutant BRAF (inhibited by TAFINLAR) and MEK (inhibited by MEKINIST).1,2 Therefore, the combination of TAFINLAR + MEKINIST provides dual inhibition of this important pathway.1,2


Who Can Be Prescribed TAFINLAR + MEKINIST?

TAFINLAR, in combination with MEKINIST, 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.

What Is BRAF Mutation and Is It Relevant to My Patient?

A BRAF mutation is present in as many as 50% of melanomas and is identified by specific genetic testing.1,3

All patients should undergo this genetic test via a biopsy of the tumour to identify if there is a BRAF mutation before they are prescribed TAFINLAR + MEKINIST.1,2 Because TAFINLAR + MEKINIST is a targeted therapy, these tests play an important role in ascertaining whether a patient is suitable for this combination. Only those who are BRAF mutation-positive can be prescribed TAFINLAR + MEKINIST.1,2

A confirmed BRAF mutation may also be referred to as:

  • BRAF V600 mutation-positive
  • BRAF positive melanoma

How to Take TAFINLAR + MEKINIST

TAFINLAR and MEKINIST are oral treatments for adult patients who have BRAF V600 mutation-positive melanoma.1,2 See below diagrams for information on dosing and administration of TAFINLAR + MEKINIST, as well as for practical advice you may want to provide to your TAFINLAR + MEKINIST patients. Always encourage your patients to carefully read the Patient Information Leaflets (PILs) in their TAFINLAR and MEKINIST packs before starting treatment, as they contain important information for them.1,2

Dosing and administration: starting treatment1,2^

The recommended dose of TAFINLAR is 150 mg twice daily

The recommended dose of MEKINIST is 2 mg once daily

^Representative images not to size and based on dosing recommendations1,2

Practical advice to patients on taking TAFINLAR + MEKINIST1,2

Some patients may not know how to take TAFINLAR + MEKINIST and it may be helpful to share the following tips with them:

1

Swallow the capsules or tablets whole, with water

2

Take them one at a time

3

Do not crush or chew the capsules or tablets

Travelling while on treatment is feasible as patients do not have to come into hospital to take treament.

Unopened Mekinist container must be stored in a refrigerator (2–8°C); however, once opened can be stored for 30 days at temperatures not exceeding 30°C.

TAFINLAR does not require any special storage conditions.

Tafinlar + Mekinist treatment should be taken at the same time each day and either 1 hour before or 2 hours after a meal.

 
 

Building TAFINLAR + MEKINIST into daily life1,2

Taking new medications every day can be an adjustment for some people, so it may be helpful to explore different ways in which it can be built into their regular routine. Examples may include:

 

Setting regular alarms for the same time every day

Use of a medicines adherence app that sends reminders

Arranging tablets in a labelled medicine case

Creating a tick chart to put by a calendar or home noticeboard

 

Supporting a Patient if a Dose of TAFINLAR + MEKINIST Is Missed

Sometimes patients miss a dose, deliberately or by accident. Reasons may include:

  • They may decide to skip a dose due to side effects such as vomiting or nausea. It is important that you help them avoid skipping doses by encouraging them to talk with their healthcare professional who will be able to offer advice about managing side effects of treatment with TAFINLAR + MEKINIST.1,2
  • They may forget the treatment regimen timings. To help prevent this, consider providing patients with practical advice on taking TAFINLAR + MEKINIST [see above, Building TAFINLAR + MEKINIST into daily life].  Any additional advice you can provide will help your patients anticipate any challenges they may encounter.1,2

If a dose of TAFINLAR is missed, the dose should only be taken if it is more than 6 hours until the next scheduled dose. If a dose of MEKINIST is missed, the dose should only be taken if it is more than 12 hours until the next scheduled dose.1,2

If a patient vomits after taking TAFINLAR or MEKINIST, the patient should not retake the dose, but wait until the next scheduled dose. Please refer to the TAFINLAR Summary of Product Characteristics (SPC) and/or MEKINIST Summary of Product Characteristics (SPC) for further information on advice on missed doses of TAFINLAR and/or MEKINIST.1,2


How Long Is TAFINLAR + MEKINIST Taken For?

In the METASTATIC treatment of melanoma, patients should be treated with both TAFINLAR and MEKINIST until the patient no longer derives benefit or develops unacceptable toxicity.1,2

In the ADJUVANT treatment of melanoma, patients should be treated for a period of 12 months unless there is disease recurrence or unacceptable toxicity.1

Any variation in dosing and administration should be discussed with a healthcare professional.


Discussing Side Effects With My Patients

People who are taking TAFINLAR + MEKINIST as a treatment for melanoma, may experience a range of side effects. The most common (incidence ≥20%) side effects of TAFINLAR, in combination with MEKINIST, include pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.1,2 These will vary from person to person, as will the degree of severity.1,2

To ensure patients are able to continue with treatment, flexible dose modifications can be used to help manage certain side effects.1,2 Any changes to dosage should be instructed by the treating healthcare professional.

Symptoms to look out for:

  • Pyrexia / fever
  • Fatigue
  • Nausea / vomiting
  • Chills / rigor
  • Headache
  • Diarrhoea / stomach pain
  • Arthralgia / joint pain
  • Skin changes

For more information on potential side effects and how to manage them in patients receiving TAFINLAR + MEKINIST please refer to the TAFINLAR SPC and PIL + MEKINIST SPC and PIL.1,2

Please also note that Novartis provides further supporting materials for patients treated with TAFINLAR + MEKINIST and please contact a Novartis representative for further details.


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. Flaherty KT, et al. Presented at ASCO 2016; 3–7 June, Chicago, USA.
Rate this content: 
No votes yet
UK | December 2020 | 100920
×

Ask Speakers

×

Medical Information Request

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]