What is the most important information I should know about binimetinib?
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.
What is binimetinib?
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.
What should I discuss with my healthcare provider before taking binimetinib?
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 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.
How should I take binimetinib?
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.
What happens if I miss a 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking binimetinib?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of binimetinib?
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 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.
What other drugs will affect binimetinib?
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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