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Mekinist Dosage

Generic name: TRAMETINIB DIMETHYL SULFOXIDE 0.5mg
Dosage form: tablet, film coated

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

2.1 Patient Selection

Select patients for treatment of unresectable or metastatic melanoma with MEKINIST based on the presence of BRAF V600E or V600K mutation in tumor specimens [see Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dosing

The recommended dosage regimen is MEKINIST 2 mg orally taken once daily at the same time each day as a single agent or with dabrafenib. Continue treatment until disease progression or unacceptable toxicity occurs.

Take MEKINIST at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3)]. Do not take a missed dose of MEKINIST within 12 hours of the next dose of MEKINIST.

2.3 Dose Modifications

Review the Full Prescribing Information for dabrafenib for recommended dose modifications. Dose modifications are not recommended for MEKINIST when administered with dabrafenib for the following adverse reactions of dabrafenib: non-cutaneous malignancies and uveitis.

For New Primary Cutaneous Malignancies

No dose modifications are required.

Table 1. Recommended Dose Reductions

Dose Reductions for MEKINIST

First Dose Reduction

1.5 mg orally once daily

Second Dose Reduction

1 mg orally once daily

Subsequent Modification

Permanently discontinue if unable to tolerate MEKINIST 1 mg orally once daily

Table 2. Recommended Dose Modifications for MEKINIST

Severity of Adverse Reactiona

MEKINISTb

Febrile Drug Reaction

Fever higher than 104°F
Fever complicated by rigors, hypotension, dehydration, or renal failure

Withhold MEKINIST until fever resolves. Then resume MEKINIST at same or lower dose level.

Cutaneous

Intolerable Grade 2 skin toxicity
Grade 3 or 4 skin toxicity

Withhold MEKINIST for up to 3 weeks.

If improved, resume at a lower dose level.
If not improved, permanently discontinue.

Cardiac

Asymptomatic, absolute decrease in left ventricular ejection fraction (LVEF) of 10% or greater from baseline and is below institutional lower limits of normal (LLN) from pretreatment value
 
Withhold MEKINIST for up to 4 weeks.
If improved to normal LVEF value, resume at a lower dose level.
If not improved to normal LVEF value, permanently discontinue.
Symptomatic congestive heart failure
Absolute decrease in LVEF of greater than 20% from baseline that is below LLN

Permanently discontinue MEKINIST.

Venous Thromboembolism

Uncomplicated DVT or PE

Withhold MEKINIST for up to 3 weeks.

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.
Life threatening PE

Permanently discontinue MEKINIST.

Ocular Toxicities

Retinal pigment epithelial detachments (RPED)

Withhold MEKINIST for up to 3 weeks.

If improved, resume MEKINIST at same or lower dose level.
If not improved, discontinue or resume at a lower dose.
Retinal vein occlusion

Permanently discontinue MEKINIST.

Pulmonary

Interstitial lung disease/pneumonitis

Permanently discontinue MEKINIST.

Other

Intolerable Grade 2 adverse reactions
Any Grade 3 adverse reactions

Withhold MEKINIST

If improved to Grade 0-1, resume at a lower dose level.
If not improved, permanently discontinue.
First occurrence of any Grade 4 adverse reaction
Withhold MEKINIST until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.

Or

Permanently discontinue.
Recurrent Grade 4 adverse reaction

Permanently discontinue MEKINIST.

aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

bSee Table 1 for recommended dose reductions of MEKINIST.

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