Skip to Content

Mekinist Dosage

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

Medically reviewed on May 4, 2018.

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), (14.2)].
  • 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 (14.3)].
  • Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

ATC

  • Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies (14.4)].

Recommended Dosage for Unresectable or Metastatic Melanoma

The recommended dosage of MEKINIST is 2 mg orally taken once daily, as a single agent or in combination with dabrafenib, until disease progression or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for the Adjuvant Treatment of Melanoma

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for NSCLC

The recommended dose of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage for ATC

The recommended dose of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Administration

  • Take MEKINIST doses approximately 24 hours apart.
  • 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.

Dosage Modifications for Adverse Reactions

Dose reductions for adverse reactions associated with MEKINIST are presented in Table 1.

Table 1. Recommended Dose Reductions for MEKINIST for Adverse Reactions
Action Recommended Dose
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

Dosage modifications for adverse reactions associated with MEKINIST are presented in Table 2.

Table 2. Recommended Dosage Modifications for MEKINIST for Adverse Reactions
Severity of Adverse Reactiona MEKINISTb
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.
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.
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.
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.
Dermatologic
  • Intolerable Grade 2
  • Grade 3 or 4
Withhold MEKINIST for up to 3 weeks.
  • If improved, resume at a lower dose level.
  • If not improved, permanently discontinue.
Other Adverse Reactionsc
  • Intolerable Grade 2
  • Any Grade 3
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
  • Withhold MEKINIST until adverse reaction improves to Grade 0-1. Then resume at a lower dose level.
Or
  • Permanently discontinue.
  • Recurrent Grade 4
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.

c Dose modifications are not recommended for MEKINIST when administered with dabrafenib for the following adverse reactions
of dabrafenib: non-cutaneous malignancies and uveitis. Dose modification of MEKINIST is not required for new primary
cutaneous malignancies.

Refer to the dabrafenib prescribing information for dose modifications for adverse reactions associated with dabrafenib.

Further information

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

Hide