MEKINIST (trametinib) tablet, film coated
[GlaxoSmithKline LLC]

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MEKINIST safely and effectively. See full prescribing information for MEKINIST.
MEKINIST (trametinib) tablets, for oral use
Initial U.S. Approval: 2013
 
INDICATIONS AND USAGE
MEKINIST is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (1) (1)

Limitation of use: MEKINIST is not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy. (1) (1)

DOSAGE AND ADMINISTRATION
•
Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST. (2.1)
•
The recommended dose is 2 mg orally once daily taken at least 1 hour before or at least 2 hours after a meal. (2.2)

DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg, 1 mg, and 2 mg. (3) (3)

CONTRAINDICATIONS
None. (4) (4)

WARNINGS AND PRECAUTIONS
•
Cardiomyopathy: Re-assess LVEF after one month of treatment, and eva luate approximately every 2 to 3 months thereafter. (5.1)
•
Retinal Pigment Epithelial Detachment (RPED): Perform ophthalmologic eva luation for any visual disturbances. Withhold MEKINIST if RPED is diagnosed and discontinue if no improvement after 3 weeks. (5.2)
•
Retinal Vein Occlusion (RVO): Discontinue MEKINIST. (5.3)
•
Interstitial Lung Disease (ILD): Withhold MEKINIST for new or progressive unexplained pulmonary symptoms or findings, such as cough, dyspnea, hypoxia, or infiltrates. Permanently discontinue MEKINIST for treatment-related ILD or pneumonitis. (5.4)
•
Serious Skin Toxicity: Monitor for skin toxicities and for secondary infections. Discontinue for intolerable Grade 2, or Grade 3 or 4 rash not improving within 3 weeks despite interruption of MEKINIST. (5.5)
•
Embryofetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus. (5.6, 8.1, 8.6)
ADVERSE REACTIONS
Most common adverse reactions (≥20%) for MEKINIST include rash, diarrhea, and lymphedema. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS
•
Nursing Mothers: Discontinue drug or nursing. (8.3)
•
Females and Males of Reproductive Potential: Counsel female patients on pregnancy planning and prevention. May impair fertility. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 05/2013

Back to Highlights and Tabs
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosing
2.3 Dose Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
5.2 Retinal Pigment Epithelial Detachment (RPED)
5.3 Retinal Vein Occlusion (RVO)
5.4 Interstitial Lung Disease
5.5 Serious Skin Toxicity
5.6 Embryofetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothe