Skip to Content

Mekinist Dosage

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

Medically reviewed by Drugs.com. Last updated on Oct 6, 2019.

Patient Selection

Melanoma

  • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST as a single agent or in combination with 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)]. An FDA-approved test for the detection of BRAF V600E mutation in ATC is not currently available.

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 dosage 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 dosage 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
aNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
bSee Table 1 for recommended dose reductions of MEKINIST.
cDose 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.
Severity of Adverse Reactiona Dosage Modification for MEKINISTb
Venous Thromboembolism [see Warnings and Precautions (5.4)]
  • Uncomplicated deep venous thrombosis (DVT) or pulmonary embolism (PE)
Withhold MEKINIST for up to 3 weeks.
  • If improved to Grade 0-1, resume MEKINIST at lower dose.
  • If not improved, permanently discontinue MEKINIST.
  • Life threatening PE
Permanently discontinue MEKINIST.
Cardiomyopathy [see Warnings and Precautions (5.5)]
  • Asymptomatic, absolute decrease in left ventricular ejection fraction (LVEF) of 10% or greater from baseline and is below institutional lower limit of normal (LLN) from pretreatment value
Withhold MEKINIST for up to 4 weeks.
  • If improved to normal LVEF value, resume MEKINIST at lower dose.
  • If not improved to normal LVEF value, permanently discontinue MEKINIST.
  • Symptomatic cardiomyopathy
  • Absolute decrease in LVEF of greater than 20% from baseline that is below LLN
Permanently discontinue MEKINIST.
Ocular Toxicities [see Warnings and Precautions (5.6)]
  • Retinal pigment epithelial detachments (RPED)
Withhold MEKINIST for up to 3 weeks.
  • If improved, resume MEKINIST at same or lower dose.
  • If not improved, permanently discontinue MEKINIST or resume MEKINIST at lower dose.
  • Retinal vein occlusion (RVO)
Permanently discontinue MEKINIST.
Pulmonary [see Warnings and Precautions (5.7)]
  • Interstitial lung disease (ILD)/pneumonitis
Permanently discontinue MEKINIST.
Febrile Reactions [see Warnings and Precautions (5.8)]
  • 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.
Skin Toxicity [see Warnings and Precautions (5.9)]
  • Intolerable Grade 2
  • Grade 3 or 4
Withhold MEKINIST for up to 3 weeks.
  • If improved, resume MEKINIST at lower dose.
  • If not improved, permanently discontinue.
Other Adverse Reactionsc, including Hemorrhage [see Warnings and Precautions (5.2)]
  • Intolerable Grade 2
  • Any Grade 3
Withhold MEKINIST
  • If improved to Grade 0-1, resume at lower dose.
  • If not improved, permanently discontinue.
  • First occurrence of any Grade 4
  • Withhold MEKINIST until improves to Grade 0-1, then resume at lower dose.
Or
  • Permanently discontinue MEKINIST.
  • Recurrent Grade 4
Permanently discontinue MEKINIST.

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