Venous Thrombosis

Advise patients to contact their healthcare provider if they experience symptoms of venous thrombosis orpulmonary embolism. Advise patients to seek medical attention for sudden onset of difficulty breathing, leg

pain, or swelling [see Warnings and Precautions (5.2)].

Ocular Toxicities

Advise patients to contact their healthcare provider if they experience any changes in their vision [seeWarnings and Precautions (5.3)].

Interstitial Lung Disease

Advise patients to contact their healthcare provider if they experience any new or worsening respiratorysymptoms including cough or dyspnea [see Warnings and Precautions (5.4)].

Hepatotoxicity

Advise patients that serial testing of serum liver tests (ALT, AST, bilirubin) is recommended duringtreatment with MEKTOVI. Instruct patients to report symptoms of liver dysfunction including jaundice,

dark urine, nausea, vomiting, loss of appetite, fatigue, bruising, or bleeding [see Warnings and Precautions(5.5)].

Rhabdomyolysis

Advise patients to contact their healthcare provider as soon as possible if they experience unusual or newonset weakness, myalgia, or darkened urine [see Warnings and Precautions (5.6)].

Hemorrhage

Advise patients to notify their healthcare provider if they experience symptoms suggestive of hemorrhage,such as unusual bleeding [see Warnings and Precautions (5.7)].

Females and Males of Reproductive Potential

Embryo-Fetal Toxicity: Advise females with reproductive potential of the potential risk to a fetus. Advisefemales of reproductive potential to use effective contraception during treatment with MEKTOVI and for 30

days after the final dose. Advise females to contact their healthcare provider if they become pregnant, or ifpregnancy is suspected, during treatment with MEKTOVI [see Warnings and Precautions (5.8), Use in

Specific Populations (8.1)].

Lactation: Advise women not to breastfeed during treatment with MEKTOVI and for 3 days after the finaldose [see Use in Specific Populations (8.2)]. 

Distributed by:

Array BioPharma Inc.

3200 Walnut Street

Boulder, CO 80301

 

© 2018 Array BioPharma Inc. All rights reserved.

 

MEKTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various othercountries.

 

Patented. See www.arraybiopharma.com/patents

 

PATIENT INFORMATION

MEKTOVI® (mek-TOE-vee)

(binimetinib)

tablets

Important Information: If your healthcare provider prescribes MEKTOVI with encorafenib, please read the MedicationGuide that comes with encorafenib.

What is MEKTOVI?

MEKTOVI is a prescription medicine used in combination with a medicine called encorafenib to treat people with a typeof 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

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

It is not known if MEKTOVI is safe and effective in children.

Before taking MEKTOVI, tell your healthcare provider about all of your medical conditions, including if you:

 have heart problems

 have had blood clots