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Trametinib Dosage

Medically reviewed on May 24, 2018.

Applies to the following strengths: 0.5 mg; 2 mg

Usual Adult Dose for Melanoma - Metastatic

Unresectable or Metastatic Melanoma:
-Single agent: 2 mg orally once a day
-Combination therapy: 2 mg orally once a day with dabrafenib (refer to the dabrafenib prescribing information for recommended dabrafenib dosing information)
-Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Adjuvant Treatment of Melanoma:
-Combination therapy: 2 mg orally once a day with dabrafenib (refer to the dabrafenib prescribing information for recommended dabrafenib dosing information)
-Duration of therapy: Until disease progression or unacceptable toxicity occurs for up to one year.

Comments:
-Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation.
-This drug should be taken without food, at least 1 hour before or 2 hours after a meal.
-This drug should be taken with a full glass of water.
-When this drug and dabrafenib are taken in combination, the dose of this drug should be taken at the same time each day with either the morning or evening dose of dabrafenib.
-If a dose is missed, only take the dose if it is more than 12 hours until the next scheduled dose.

Uses:
-As a single agent or in combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test
-In combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection

Usual Adult Dose for Non-Small Cell Lung Cancer

2 mg orally once a day with dabrafenib (refer to the dabrafenib prescribing information for recommended dabrafenib dosing information)
Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy with this drug and dabrafenib.
-This drug should be taken without food, at least 1 hour before or 2 hours after a meal.
-This drug should be taken with a full glass of water.
-When this drug and dabrafenib are taken in combination, the dose of this drug should be taken at the same time each day with either the morning or evening dose of dabrafenib.
-If a dose is missed, only take the dose if it is more than 12 hours until the next scheduled dose.

Use: In combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test

Usual Adult Dose for Thyroid Cancer

2 mg orally once a day with dabrafenib (refer to the dabrafenib prescribing information for recommended dabrafenib dosing information)
Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy with this drug and dabrafenib.
-This drug should be taken without food, at least 1 hour before or 2 hours after a meal.
-This drug should be taken with a full glass of water.
-When this drug and dabrafenib are taken in combination, the dose of this drug should be taken at the same time each day with either the morning or evening dose of dabrafenib.
-If a dose is missed, only take the dose if it is more than 12 hours until the next scheduled dose.

Use: In combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options

Renal Dose Adjustments

Mild (CrCl 60 to less than 90 mL/min) to moderate (CrCl 30 to less than 60 mL/min): No adjustment recommended.
Severe (CrCl 15 to less than 30 mL/min) or end-stage renal disease (CrCl less than 15 mL/min): Data not available

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Dose Adjustments

Recommended Dose Reductions for Adverse Reactions:
-First dose reduction: 1.5 mg orally once a day
-Second dose reduction: 1 mg orally once a day
-Subsequent modification: Permanently discontinue therapy if unable to tolerate 1 mg orally once a day

Venous Thromboembolism:
-Uncomplicated DVT or PE: Withhold therapy for up to 3 weeks; if improved to Grade 0 or 1, resume at a lower dose level; if not improved, permanently discontinue therapy.
-Life threatening PE: Permanently discontinue therapy.

Cardiac Toxicity:
-Asymptomatic, absolute decrease in left ventricular ejection fraction (LVEF) of 10% or greater from baseline that is below institutional lower limits of normal (LLN) from pretreatment value: Withhold therapy for up to 4 weeks; if improved to normal LVEF value, resume therapy at a lower dose; if not improved to normal LVEF value, permanently discontinue therapy.
-Symptomatic congestive heart failure or an absolute decrease in LVEF of greater than 20% from baseline that is below LLN: Permanently discontinue therapy.

Ocular Toxicity:
-Retinal pigment epithelial detachments (RPED): Withhold therapy for up to 3 weeks; if improved, resume therapy at same or lower dose level; if not improved, discontinue therapy or resume at a lower dose.
-Retinal vein occlusion: Permanently discontinue therapy.

Pulmonary Toxicity:
Interstitial lung disease/pneumonitis: Permanently discontinue therapy.

Febrile Drug Reactions:
-Fever higher than 104F or fever complicated by rigors, hypotension, dehydration or renal failure: Withhold therapy until fever resolves, then resume at same or lower dose level.

Dermatologic Toxicity:
-Grade 3 or 4 or intolerable Grade 2: Withhold therapy for up to 3 weeks; if improved, resume therapy at a lower dose level; if not improved, permanently discontinue therapy.

Other Adverse Reactions (dose modifications are not recommended for this drug when administered with dabrafenib for the following adverse reactions of dabrafenib: non-cutaneous malignancies and uveitis; dose modification of this drug is not required for new primary cutaneous malignancies):
-Any Grade 3 or intolerable Grade 2 adverse reaction: Withhold therapy; if improved to Grade 0 to 1, resume therapy at a lower dose level, if not improved, permanently discontinue therapy.
-First occurrence of any Grade 4 adverse reaction: Withhold therapy until adverse reaction improves to Grade 0 to 1, then resume therapy at a lower dose level; if not improved, permanently discontinue therapy.
-Recurrent Grade 4 adverse reaction: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be taken without food, at least 1 hour before or 2 hours after a meal.
-When this drug and dabrafenib are taken in combination, the dose of this drug should be taken at the same time each day with either the morning or evening dose of dabrafenib.
-If a dose is missed, only take the dose if it is more than 12 hours until the next scheduled dose.

Storage requirements:
-Store refrigerated at 36 to 46 degrees Fahrenheit.
-Dispense in original container with desiccant intact.
-Protect from moisture and light.
-Do not place medication in pill boxes.

General:
-This drug is not indicated for treatment of patients with melanoma who have progressed on prior BRAF-inhibitor therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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