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.

17 PATIENT COUNSELING INFORMATION
 

See FDA-approved patient labeling (Patient Information).

Inform patients of the following:

•
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)].
•
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).]
•
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).]
•
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).]
•
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).]
•
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.
•
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.
•
MEKINIST should be taken at least 1 hour before or at least 2 hours after a meal.
•
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)].
•
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 of skin cancer called melanoma:

•
that has spread to other parts of the body or cannot be removed by surgery, and
•
that has a certain type of abnormal “BRAF” gene
MEKINIST should not be used to treat people who have received a BRAF inhibitor for treatment of their melanoma.

Your healthcare provider will perform a test to make sure that MEKINIST is right for you.

It i