Prescribing information

 

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Helping patients on their TAFINLAR + MEKINIST treatment journey

 

TAFINLAR + MEKINIST is the only oral option in the adjuvant setting, and offers the lowest pill burden among oral options in the metastatic setting1,2

Dosing is the same for both adjuvant and metastatic patients with melanoma1,2

In the metastatic setting, treatment with both TAFINLAR and MEKINIST should continue until the patient no longer derives benefit or develops unacceptable toxicity1,2

In the adjuvant setting, patients should be treated for a period of 12 months unless there is disease recurrence or unacceptable toxicity1,2

 

This key information on the dosing and administration of TAFINLAR + MEKINIST may be helpful when discussing treatment with your patients.

 

TAFINLAR + MEKINIST offers convenient oral twice daily dosing1,2

 

TAFINLAR, in combination with MEKINIST, is indicated for:

  • Adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.1,2
  • Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.1,2
Drug TAFINLAR1 MEKINIST2
Usual recommended dose Dose of TAFINLAR in combination with MEKINIST is 150 mg (two 75 mg capsules) twice daily, corresponding to a total daily dose of 300 mg Dose of MEKINIST in combination with TAFINLAR is 2 mg (one tablet) once daily
Maximum dose The dose should not exceed 150 mg twice daily The dose should not exceed 2 mg once daily

Duration of treatment

  • In the metastatic treatment of melanoma, patients should be treated with TAFINLAR + 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.1,2

Dose modifications

The management of adverse reactions associated with TAFINLAR + MEKINIST treatment may require dose reduction, treatment interruption or treatment discontinuation.1,2

For more information on dose modification guidelines please refer to the TAFINLAR + MEKINIST Summaries of Product Characteristics (SPCs) and visit the side effect management tab where this is described in detail.

How to take TAFINLAR and MEKINIST1,2

 

  TAFINLAR MEKINIST
How much to take The usual dose is 150 mg (two 75 mg capsules) twice daily. The usual dose is 2 mg (one tablet) once a day.
When to take TAFINLAR should be taken twice a day in the morning and in the evening, about 12 hours apart.

The morning and evening doses of TAFINLAR should be taken at similar times every day.
MEKINIST should be taken once a day, at about the same time each day, either with the morning or with the evening dose of TAFINLAR.
How to take TAFINLAR should be taken on an empty stomach, either 1 hour before, or 2 hours after, a meal. MEKINIST should be taken on an empty stomach, either 1 hour before, or 2 hours after, a meal.

How to take Tafinlar and Mekinist graphic.

 

Practical advice for patients on how to take their treatment and how to incorporate it into their daily lives can be found here.

 

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.1,2

What to do in certain situations when taking TAFINLAR and MEKINIST1,2

 

  TAFINLAR MEKINIST
If a patient forgets to take TAFINLAR or MEKINIST If the missed dose is less than 6 hours late, the patient must take it as soon as they remember.


If the missed dose is more than 6 hours late, the patient should skip that dose and take the next dose at the usual time. Then carry on taking the capsules at regular times as usual.


The patient must not take a double dose to make up for a missed dose.
If the missed dose is less than 12 hours late, the patient must take it as soon as they remember.


If the missed dose is more than 12 hours late, the patient should skip that dose and take the next dose at the usual time. Then carry on taking the capsules at regular times as usual.


The patient must not take a double dose to make up for a missed dose.
If a patient cannot remember if they have taken TAFINLAR or MEKINIST The patient must not take any TAFINLAR capsules in case they have already taken some.

The patient must take next dose at the usual scheduled time. Then carry on taking the tablets at regular times as usual.
The patient must not take a MEKINIST tablet in case they have already taken one.

The patient must take next dose at the usual scheduled time. Then carry on taking the tablets at regular times as usual.
If a patient vomits after taking TAFINLAR or MEKINIST The patient must not take the capsules or tablet again but wait until next dose is due and take it at the normal time.
If a patient has taken more than the prescribed number of TAFINLAR capsules, MEKINIST tablets, or other medicines The patient must consult a doctor, pharmacist, or nurse immediately, and take the medicine(s) and its packaging with them if seeing them face-to-face.

Handling of TAFINLAR and MEKINIST

  • TAFINLAR capsules and MEKINIST tablets should be handled according to local handling requirements; small molecule kinase inhibitors would not generally be classed as cytotoxic for handling purposes.1,2
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1,2

Storage of TAFINLAR and MEKINIST

  • MEKINIST must be stored in a refrigerator (2°C to 8°C) in its original packaging to protect it from light and moisture until opened.2 After this, the opened bottle has a shelf life of 30 days and can be stored outside of a refrigerator at no more than 30°C.3
  • TAFINLAR requires no special storage conditions. The shelf life of TAFINLAR capsules is three years.1

For more detailed information on dosing and administration please refer to the TAFINLAR + MEKINIST SPCs.1,2

SPC for TAFINLAR

SPC for MEKINIST

Additional information is also available from your Novartis representative, who can provide you with a comprehensive healthcare professional brochure about TAFINLAR + MEKINIST.

References

  1. TAFINLAR (dabrafenib) Summary of Product Characteristics.
  2. MEKINIST (trametinib) Summary of Product Characteristics.
  3. Novartis data on file. Data to support temperature excursions during storage of trametinib tablets. Document number 2013N165534_01, July 2013.  
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UK | October 2021 | 122587
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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]