Active Ingredient: Trametinib
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older 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:
For:
Oral, 2 milligrams trametinib, once daily.
In adults, the recommended dose of trametinib is 2 mg once daily, regardless of body weight.
It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity.
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.
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.
For:
Regimen A, in the case that patient weight is ≥ 26 kg and patient weight is ≤ 37 kg :
Oral, 1 milligrams trametinib, once daily.
Regimen B, in the case that patient weight is ≥ 38 kg and patient weight is ≤ 50 kg :
Oral, 1.5 milligrams trametinib, once daily.
Regimen C, in the case that patient weight is ≥ 51 kg :
Oral, 2 milligrams trametinib, once daily.
In adolescents (aged 12 to <18 years) with melanoma, the recommended dose of trametinib is based on body weight:
It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity.
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.
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.
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