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Mekinist Dosage

Generic name: TRAMETINIB DIMETHYL SULFOXIDE .5mg
Dosage form: tablet, film coated

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

Patient Selection

Melanoma

Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [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.

NSCLC

Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

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.

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.

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

b See Table 1 for recommended dose reductions of MEKINIST.

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