Melanoma with a BRAF V600 mutation

Active Ingredient: Trametinib

Indication for Trametinib

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

For this indication, competent medicine agencies globally authorize below treatments:

2 mg once daily

For:

Dosage regimens

Oral, 2 milligrams trametinib, once daily.

Detailed description

The recommended dose of trametinib, either used as monotherapy or in combination with dabrafenib, is 2 mg once daily. The recommended dose of dabrafenib, when used in combination with trametinib, is 150 mg twice daily.

Duration of treatment

It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity. In the adjuvant melanoma setting, patients should be treated for a period of 12 months unless there is disease recurrence or unacceptable toxicity.

Missed doses

If a dose of trametinib is missed, it should only be taken if it is more than 12 hours until the next scheduled dose.

If a dose of dabrafenib is missed, when trametinib is given in combination with dabrafenib, the dose of dabrafenib should only be taken if it is more than 6 hours until the next scheduled dose.

Dosage considerations

Trametinib should be taken orally without food, at least 1 hour before or 2 hours after a meal.

It is recommended that the dose of trametinib is taken at a similar time every day. When trametinib and dabrafenib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib.

If a patient vomits after taking trametinib, the patient should not retake the dose and should take the next scheduled dose.

Active ingredient

Trametinib

Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity. In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK. Trametinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity.

Read more about Trametinib

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