Mekinist Dosage

Generic name: trametinib
Dosage form: tablet, film coated

This dosage information does not include all the information needed to use Mekinist safely and effectively. See full prescribing information for Mekinist.

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

Patient Selection

Select patients for treatment of unresectable or metastatic melanoma with MEKINIST based on 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.

Recommended Dosing

The recommended dose is 2 mg orally once daily until disease progression or unacceptable toxicity. Take at least 1 hour before or 2 hours after a meal. Do not take a missed dose within 12 hours of the next dose.

Dose Modifications

Table 1. Recommended Dose Modifications for MEKINIST
 
Target Organ
 
Adverse Reactiona
 
Dose Modification
 
Cutaneous
 
Grade 2 rash
 
Reduce dose of MEKINIST by 0.5 mg or discontinue MEKINIST in patients taking MEKINIST 1 mg daily
 
Intolerable Grade 2 rash that does not improve within 3 weeks following dose reduction
 
Grade 3 or 4 rash
 
Withhold MEKINIST for up to 3 weeks
 
If improved within 3 weeks, resume MEKINIST at a lower dose (reduced by 0.5 mg) or discontinue MEKINIST in patients taking MEKINIST 1 mg daily
 
 
Intolerable Grade 2, or Grade 3 or 4 rash that does not improve within 3 weeks despite interruption of dosing of MEKINIST
 
Permanently discontinue MEKINIST
 
 
Cardiac
 
Asymptomatic, absolute decrease in 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
 
Asymptomatic, absolute decrease in LVEF of 10% or greater from baseline and is below LLN that improves to normal LVEF value within 4 weeks following interruption of MEKINIST
 
If improved within 4 weeks, resume MEKINIST at a lower dose (reduced by 0.5 mg) or discontinue MEKINIST in patients taking MEKINIST 1 mg daily
 
 
Symptomatic congestive heart failure
 
Absolute decrease in LVEF of greater than 20% from baseline that is below LLN
 
Absolute decrease in LVEF of 10% or greater from baseline and is below LLN that does not improve to normal LVEF value within 4 weeks following interruption of MEKINIST
 
Permanently discontinue MEKINIST
 
 
Ocular
 
Grade 2-3 retinal pigment epithelial detachments (RPED)
 
Withhold MEKINIST for up to 3 weeks
 
Grade 2-3 RPED that improves to Grade 0-1 within 3 weeks
 
If improved within 3 weeks, resume MEKINIST at a lower dose (reduced by 0.5 mg) or discontinue MEKINIST in patients taking MEKINIST 1 mg daily
 
 
Retinal vein occlusion
 
Grade 2-3 RPED that does not improve to at least Grade 1 within 3 weeks
 
Permanently discontinue MEKINIST
 
 
Pulmonary
 
Interstitial lung disease/pneumonitis
 
Permanently discontinue MEKINIST
 
Other
 
Grade 3 adverse reaction
 
Withhold MEKINIST for up to 3 weeks
 
If Grade 3 adverse reaction improves to Grade 0-1 following interruption of MEKINIST within 3 weeks
 
Reduce dose of MEKINIST by 0.5 mg or discontinue MEKINIST in patients taking MEKINIST 1 mg daily
 
 
Grade 4 adverse reaction
 
Grade 3 adverse reaction that does not improve to Grade 0-1 within 3 weeks
 
Permanently discontinue MEKINIST
 

a Note: The intensity of clinical adverse events graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

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