How Supplied/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).
1 mg Tablets: White, round, biconvex, film-coated tablets with ‘GS’ debossed on one face and ‘LHE’ on the opposing face and are available in bottles of 30 (NDC 0173-0858-13).
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 bttles 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.
Patient Counseling Information
See FDA-approved patient labeling (Patient Information).
Inform patients of the following:
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Evidence of BRAF V600E or V600K mutation within the tumor specimen is necessary to identify patients for whom treatment with Mekinist is indicated [see Dosage and Administration (2.1)].
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Mekinist can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider. [See Warnings and Precautions (5.1).]
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Mekinist causes severe visual disturbances that can lead to blindness. Advise patients to contact their healthcare provider if they experience any changes in their vision. [See Warnings and Precautions (5.2, 5.3).]
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Mekinist can cause interstitial lung disease (or pneumonitis). Advise patients to contact their healthcare provider as soon as possible if they experience dyspnea. [See Warnings and Precautions (5.4).]
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Mekinist often causes skin toxicities including acneiform rash. Advise patients to contact their healthcare provider for progressive or intolerable rash. [See Warnings and Precautions (5.5).]
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Mekinist causes hypertension. Advise patients that they need to undergo blood pressure monitoring and to contact their healthcare provider if they develop symptoms of hypertension.
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Mekinist often causes diarrhea which may be severe in some cases. Inform patients of the need to contact their healthcare provider if severe diarrhea occurs during treatment.
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Mekinist should be taken at least 1 hour before or at least 2 hours after a meal.
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Mekinist can cause fetal harm if taken during pregnancy. Instruct female patients to use highly effective contraception during treatment and for 4 months after treatment. Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking Mekinist [see Use in Specific Populations (8.1, 8.6)].
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Nursing infants may experience serious adverse reactions if the mother is taking Mekinist. Advise lactating mothers to discontinue nursing while taking Mekinist [see Use in Specific Populations (8.3)].
Mekinist is a trademark of GlaxoSmithKline.
THxID BRAF™ assay is a trademark of bioMerieux.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2013, GlaxoSmithKline. All rights reserved.
MKN:1PI
Patient Information
Mekinist™ (MEK-in-ist)
(trametinib)
tablets
What is Mekinist?
Mekinist is a prescription medicine used to treat people with a type
