Important Information: If your healthcare provider prescribes MEKTOVI with encorafenib, please read the Medication Guide that comes with encorafenib.
What is the most important information I should know about MEKTOVI when taken in combination with encorafenib?
MEKTOVI when taken in combination with encorafenib may cause serious side effects, including:
Talk to your healthcare provider about your risk for these cancers.
Check your skin and tell your healthcare provider right away about any skin changes, including a:
What is MEKTOVI?
MEKTOVI is a prescription medicine used:
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:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take MEKTOVI?
What are the possible side effects of MEKTOVI?
MEKTOVI may cause serious side effects, including:
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with MEKTOVI if you have certain side effects.
The most common side effects of MEKTOVI when taken with encorafenib for melanoma include:
The most common side effects of MEKTOVI when taken with encorafenib for NSCLC include:
These are not all of the possible side effects of MEKTOVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer Inc. at 1-800-438-1985.
How should I store MEKTOVI?
Keep MEKTOVI and all medicines out of the reach of children.
General information about the safe and effective use of MEKTOVI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MEKTOVI for a condition for which it was not prescribed. Do not give MEKTOVI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about MEKTOVI that is written for health professionals.
What are the ingredients in MEKTOVI?
Active ingredient: binimetinib
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate (vegetable source), and colloidal silicon dioxide
Tablet coating: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, ferric oxide yellow, ferrosoferric oxide
Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, Colorado 80301.
MEKTOVI is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
For more information, go to www.BRAFTOVIMEKTOVI.com or call 1-844-792-7729.
©2020 Array BioPharma Inc. All rights reserved.
This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 10/2023
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients of the following:
New Primary Malignancies
Advise patients that MEKTOVI administered with encorafenib can result in the development of new primary cutaneous and non-cutaneous malignancies. Advise patients to contact their healthcare provider immediately for any new lesions, changes to existing lesions on their skin, or other signs and symptoms of malignancies [see Warnings and Precautions (5.1)].
Advise patients to report any symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.2)].
Advise patients to contact their healthcare provider if they experience symptoms of venous thrombosis or pulmonary embolism. Advise patients to seek medical attention for sudden onset of difficulty breathing, leg pain, or swelling [see Warnings and Precautions (5.3)].
Advise patients to contact their healthcare provider as soon as possible if they experience any changes in their vision [see Warnings and Precautions (5.4)].
Interstitial Lung Disease
Advise patients to contact their healthcare provider if they experience any new or worsening respiratory symptoms including cough or dyspnea [see Warnings and Precautions (5.5)].
Advise patients that serial testing of serum liver tests (ALT, AST, bilirubin) is recommended during treatment 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 (5.6)].
Advise patients to contact their healthcare provider as soon as possible if they experience unusual or new onset weakness, myalgia, or darkened urine [see Warnings and Precautions (5.7)].
Advise patients to notify their healthcare provider if they experience symptoms suggestive of hemorrhage, such as unusual bleeding [see Warnings and Precautions (5.8)].
Females and Males of Reproductive Potential
Embryo-Fetal Toxicity: Advise females with reproductive potential of the potential risk to a fetus. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with MEKTOVI [see Warnings and Precautions (5.9), Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with MEKTOVI and for 30 days after the last dose.
Lactation: Advise women not to breastfeed during treatment with MEKTOVI and for 3 days after the last dose [see Use in Specific Populations (8.2)].
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