Prescribing information

 

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Tafinlar + Mekinist offers convenient oral dosing1,2

 

The key information on dosing and administration of Tafinlar + Mekinist provided below may be helpful when discussing treatment management with your patients.

Please see links to the Summaries of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for Tafinlar and Mekinist at the bottom of this page.

Administration of Tafinlar and Mekinist

The diagram below provides an overview on how to take Tafinlar and Mekinist.1,2 

Under the title 'Administration of Tafinlar + Mekinist', a diagram of providing an overview of how to take Tafinlar + Mekinist. Images- clock with '1 hour' text written on it. Clock image with '2 hours' text written on it. A cup of water with an indication to tafinlar capsule and to mekinist tablet, with dosing information text written underneath the tafinlar and mekinist tablets.

It is recommended that the doses of Tafinlar be taken at similar times every day, leaving an interval of approximately 12 hours between doses. When Tafinlar and Mekinist are taken in combination, the once-daily dose of Mekinist should be taken at the same time each day with either the morning dose or the evening dose of Tafinlar. Tafinlar should be taken at least one hour before, or at least 2 hours after a meal.1,2

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.

  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.
  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.3,4
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.

The management of adverse reactions associated with Tafinlar + Mekinist treatment may require dose reduction, treatment interruption or treatment discontinuation.3,4

 

A small icon of tablets.

Two Tafinlar capsule strengths (50 mg and 75 mg) and two Mekinist tablet strengths (0.5 mg and 2 mg) are available to manage dose modifications1,2

 

Dose modification schedule based on the grade of any adverse events3,4

Dose level Tafinlar dose Mekinist dose
Starting dose 150 mg twice daily 2 mg once daily
1st dose reduction 100 mg twice daily 1.5 mg once daily
2nd dose reduction 75 mg twice daily 1 mg once daily
3rd dose reduction 50 mg twice daily 1 mg once daily
  Dose adjustment of Tafinlar <50 mg twice daily is not recommended Dose adjustment of Mekinist <1 mg once daily is not recommended

Recommended dose level reductions3,4

 

Tafinlar and Mekinist should be simultaneously dose reduced, interrupted, or discontinued. Exceptions, where dose modifications are necessary for only one of the two treatments, are shown in the table below.3,4

 

Cases where dose modifications are necessary for only one of the two treatments3,4

Modification of Tafinlar dose only Modification of Mekinist dose only
  • Uveitis
  • RAS-associated non-cutaneous malignancies
  • RVO and RPED
  • LVEF reduction
  • Interstitial lung disease/pneumonitis

LVEF, left ventricular ejection fraction; RAS, rat sarcoma; RPED, retinal pigment epithelial detachment; RVO, retinal vein occlusion.

See the Tafinlar and Mekinist SPCs for further information on dose adjustments.

Children and adolescents (<18 years) Image of a child with accompanying text 'Children and<br />
adolescents (<18 years)'.
  • The safety and efficacy of Tafinlar + Mekinist have not yet been established in children and adolescents (<18 years)
Elderly Image if a person with a walking stick with accompanying text 'Elderly'.
  • No adjustment of the initial dose of Tafinlar or Mekinist is required in patients >65 years of age
  • More frequent dose adjustments of Mekinist may be required in patients >65 years of age
Renal impairment Image of 2 kidneys with accompanying text 'Renal impairment'.
  • Mild to moderate: No dose adjustment of Tafinlar or Mekinist is required
  • Severe: Use with caution. There are no clinical data for Tafinlar or Mekinist in patients with severe renal impairment and the potential need for dose adjustment cannot be determined
Hepatic impairment Image of a liver with accompanying text 'Hepatic<br />
impairment'.
  • Mild: No dose adjustment of Tafinlar or Mekinist is required
  • Moderate to severe: Use with caution. There are no clinical data for Tafinlar or Mekinist in patients with moderate to severe hepatic impairment and the potential need for dose adjustment cannot be determined

When a patient’s side effects are effectively managed, then a return to the starting dose via dose re-escalation can be considered in the same step wise approach as for dose reductions.3,4

Please refer to the SmPCs and PILs for advice on administration, dose modifications, storage and handling of Tafinlar and Mekinist.

GB SmPC for Tafinlar

GB SmPC for Mekinist

PIL for Tafinlar

PIL for Mekinist

 

References

  1. Tafinlar Patient Information Leaflet

  2. Mekinist Patient Information Leaflet

  3. Tafinlar (dabrafenib) Summary of Product Characteristics.

  4. Mekinist (trametinib) Summary of Product Characteristics.

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UK | November 2021 | 118706
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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]vartis.com