Binimetinib is 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.

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

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

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Binimetinib 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 binimetinib, 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 for Melanoma -- Metastatic:

45 mg orally every 12 hours in combination with encorafenib until disease progression or unacceptable toxicity

Comments:
-Refer to the encorafenib prescribing information for encorafenib 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 binimetinib if you are allergic to it.

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 binimetinib 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 binimetinib 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Some side effects are more likely to occur if you take binimetinib 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 side effects of binimetinib 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 affect 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.

Keep all appointments with your doctor, eye doctor, and the laboratory. Your doctor will order certain lab tests, including eye exams, to check your body's response to binimetinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.