Binimetinib

Binimetinib is used along with encorafenib (Braftovi) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Binimetinib comes as a tablet to take by mouth. It is usually taken with or without food twice daily, approximately 12 hours apart. Take binimetinib at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take binimetinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking the medication, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease or temporarily or permanently stop your treatment depending on if you experience any side effects. Be sure to tell your doctor how you are feeling during your treatment with binimetinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking binimetinib,

• tell your doctor and pharmacist if you are allergic to binimetinib, any other medications, or any of the ingredients in binimetinib tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had heart or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should use birth control to prevent pregnancy during your treatment with binimetinib and for 30 days after your final dose. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while taking binimetinib, call your doctor immediately. Binimetinib may harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed while you are taking binimetinib and for 3 days after your final dose.

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

Take the missed dose as soon as you remember it. However, if it is within 6 hours of the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Binimetinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • fatigue

  • nausea

  • diarrhea

  • vomiting

  • abdominal pain

  • constipation

  • dizziness

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • vision changes or eye pain, swelling, or redness

  • fever, sore throat, chills, cough, or other signs of infection

  • yellow eyes or skin, dark urine, loss of appetite, fatigue, or pain or discomfort in right upper stomach area

  • unusual weakness, muscle pain, or dark red or brown urine

  • unusual bleeding or bruising; black, tarry, or bloody stools; or coughing up blood

  • shortness of breath or cough

  • sudden onset of difficulty breathing; chest pain; swelling of the feet, ankles, or lower legs; or leg pain, warmth, or swelling

  • fast, pounding heartbeat; shortness of breath; swelling of ankles and feet; or dizziness

• Binimetinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.