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Trametinib Dosage

Applies to the following strength(s): 0.5 mg ; 2 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Melanoma - Metastatic

Single agent: 2 mg orally once a day.
Combination therapy: 2 mg orally once daily with dabrafenib 150 mg orally twice a day.
Duration of therapy: Until disease progression or unacceptable toxicity occurs.

Comments:
-Take at least 1 hour before or 2 hours after a meal.
-Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation.
-Trametinib is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.
-Continue treatment until disease progression or unacceptable toxicity occurs.

Use:
-As a single agent and in combination with dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
-Trametinib as a single agent is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended
Severe renal impairment: An appropriate dose has not been established.

Liver Dose Adjustments

Mild Liver Dysfunction: No adjustment recommended
Moderate to Severe Liver Dysfunction: An appropriate dose has not been established.

Dose Adjustments

Cutaneous Toxicity:
Intolerable Grade 2 rash, or Grade 3 or 4 rash:
-Withhold trametinib for up to 3 weeks.
-If improved within 3 weeks, resume at reduced dose (reduce by 0.5 mg) or discontinue in patients taking trametinib 1 mg daily.

Intolerable Grade 2 or Grade 3 or 4 rash that does not improve within 3 weeks despite interruption of trametinib therapy:
-Permanently discontinue trametinib.

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 trametinib for up to 4 weeks.
-If improved to normal LVEF value within 4 weeks, resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue in patients taking trametinib 1 mg daily. If not, discontinue.

Symptomatic congestive heart failure or an absolute decrease in LVEF of greater than 20% from baseline that is below LLN:
-Permanently discontinue trametinib.

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

Ocular Toxicity:
Grade 2 to 3 retinal pigment epithelial detachments (RPED):
-Withhold trametinib for up to 3 weeks.
Grade 2 to 3 RPED that improves to Grade 0 to 1 within 3 weeks:
-If improved within 3 weeks, resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue in patients taking trametinib 1 mg daily.
Retinal vein occlusion or Grade 2 to 3 RPED that does not improve to at least Grade 1 within 3 weeks:
-Permanently discontinue trametinib.
Uveitis and Iritis:
-Do not modify trametinib dose.


Pulmonary Toxicity:
Interstitial lung disease/pneumonitis:
-Permanently discontinue trametinib.

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

Other:
Intolerable Grade 2 or Grade 3 adverse reaction:
-Withhold trametinib for up to 3 weeks.
-If improved, resume at lower dose level (reduce dose by 0.5 mg or discontinue in patients taking trametinib 1 mg daily).
-It not improved, permanently discontinue.

First occurrence of any Grade 4 adverse reaction:
-Withhold trametinib until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.
-Or Permanently discontinue trametinib therapy.

Recurrent Grade 4 adverse reaction:
-Permanently discontinue trametinib.

Precautions

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:
-Administer at least 1 hour before or 2 hours after a meal.
-Do not take a missed dose within 12 hours of the next dose.

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

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