July 25, 2016
Recommended Topic Related To:

Mekinist

"The US Food and Drug Administration (FDA) has approved talimogene laherparepvec (Imlygic, Amgen), which is the first oncolytic viral therapy to receive approval from the agency.

The drug is indicated for the local treatment o"...

A A A

Mekinist

Indications
Dosage
How Supplied

INDICATIONS

MEKINIST® is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Clinical Studies].

Limitation Of Use

MEKINIST is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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]. 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 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]. 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.

HOW SUPPLIED

Dosage Forms And Strengths

0.5 mg tablets: Yellow, modified oval, biconvex, film-coated tablets with 'GS' debossed on one face and 'TFC' on the opposing face.

2 mg tablets: Pink, round, biconvex, film-coated tablets with 'GS' debossed on one face and 'HMJ' on the opposing face.

Storage And Handling

0.5 mg tablets: Yellow, modified oval, biconvex, film-coated tablets with 'GS' debossed on one face and 'TFC' on the opposing face and are available in bottles of 30 (NDC 0173-0849-13).

2 mg tablets: Pink, round, biconvex, film-coated tablets with 'GS' debossed on one face and 'HMJ' on the opposing face and are available in bottles of 30 (NDC 0173-0848-13).

Store refrigerated at 2° to 8°C (36° to 46°F). Do not freeze. Dispense in original bottle. Do not remove desiccant. Protect from moisture and light. Do not place medication in pill boxes.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: November 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/22/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.