Mektovi is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Mektovi is a prescription medicine used in combination with another medicine called encorafenib (Braftovi) to treat melanoma (skin cancer) in people who have a "BRAF" gene mutation. These medicines are for use in treating melanoma that cannot be treated with surgery or has spread to other parts of the body.

Mektovi may also be used for purposes not listed in this medication guide.

Mektovi can cause birth defects. Do not use if you are pregnant. Avoid getting pregnant while using Mektovi and for at least 30 days after your last dose.

Before taking this medicine

You should not use Mektovi if you are allergic to binimetinib.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• lung disease;

• a muscle disorder;

• liver or kidney disease;

• eye problems (especially a problem with your retina); or

• bleeding problems, or a blood clot.

Do not use Mektovi if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

Tell your doctor if you think you may be pregnant. You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while using this medicine, and for at least 3 days after your last dose.

Take Mektovi exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with binimetinib.

Mektovi is usually taken twice per day (every 12 hours), with or without food.

Do not change your dose or dosing schedule without your doctor's advice.

If you vomit shortly after taking Mektovi, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Mektovi for Melanoma - Metastatic:

progression or unacceptable toxicity

Comments:
-Refer to the encorafenib prescribing information for dosing information.
-This drug may be taken with or without food.
-Do not take a missed dose within 6 hours of the next dose.
-Do not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

Use: In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

You should not use Mektovi if you are allergic to binimetinib.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• lung disease;

• a muscle disorder;

• liver or kidney disease;

• eye problems (especially a problem with your retina); or

• bleeding problems, or a blood clot.

Do not use Mektovi if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

Tell your doctor if you think you may be pregnant. You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while using this medicine, and for at least 3 days after your last dose.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Binimetinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Mektovi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take Mektovi and encorafenib together. Call your doctor at once if you have:

• cough, shortness of breath;

• unexplained muscle pain, tenderness, or weakness;

• eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

• severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;

• liver problems - nausea, vomiting, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

• signs of bleeding - weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• signs of a blood clot - chest pain, sudden cough or trouble breathing, pain or swelling in an arm or leg, pale skin, cold feeling in an arm or leg; or

• signs of a heart problem - shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Common Mektovi side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with binimetinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.