How does this medication work? What will it do for me?

Binimetinib belongs to a group of cancer fighting medications called protein kinase inhibitors. It is used with other medications in adults to treat melanoma, a type of skin cancer, that has a mutation (a change) in the "BRAF" gene and that cannot be removed by surgery or has spread to other parts of the body. People should have their cancer tested for this change in the "BRAF" gene before starting this medication.

Binimetinib works by recognizing and attaching to certain types of cancer cells. This may slow down or stop cancers from growing and dividing.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow/dark yellow, unscored, biconvex, oval, film-coated tablet, debossed with a stylized "A" on one side and "15" on the other side, contains 15 mg of binimetinib. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate (vegetable source), and microcrystalline cellulose; coating: ferric oxide yellow, ferrosoferric oxide, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

How should I use this medication?

The recommended dose of binimetinib is 45 mg (3 × 15 mg tablets) taken by mouth, twice a day, approximately 12 hours apart. This medication may be taken with or without food. Swallow the tablets whole with water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you miss a dose, and it has been less than 6 hours since the missed dose, take it as soon as possible and continue with your regular schedule. If there is less than 6 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to binimetinib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne
  • constipation
  • diarrhea
  • dizziness
  • dry, itchy skin
  • fatigue
  • hair loss
  • headache
  • inflammation under the fatty layer of skin (e.g., tender, red bumps)
  • joint pain
  • nausea
  • red, chapped, cracked skin
  • skin rash
  • stomach pain
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • fever
  • pain, loss of sensation or tingling in the hands and feet
  • swelling of hands or feet
  • signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg)
  • signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • sore, bump or wart on the skin that does not heal
  • symptoms of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • symptoms of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, or feet)
  • symptoms of lung inflammation or scarring (e.g., cough, shortness of breath, fatigue, appetite loss, weight loss)
  • sudden appearance and worsening of vision changes (e.g., blurred vision, vision loss, coloured dots in your vision, halo, eye pain, swelling, redness)
  • symptoms of bowel inflammation (e.g., severe or persistent diarrhea, abdominal pain or cramping, rectal pain or bleeding)
  • symptoms of severely increased blood pressure: (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)
  • thickening outer layers of skin

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a blood clot in the lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes)
  • symptoms of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • weakness or paralysis of face muscles

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: Binimetinib may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Heart problems: This medication may worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or arrhythmia, discuss with your doctor how this medication may affect the medical condition, how the medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

High blood pressure: Binimetinib may increase your blood pressure. Your doctor will monitor your blood pressure while you are taking this medication. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Driving/operating machinery: Binimetinib may cause vision changes or fatigue, affecting the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. As well, binimetinib may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal.

If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking binimetinib contact your doctor immediately.

Muscle effects:  Muscle damage has been associated with the use of binimetinib. Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Melanoma: New cancerous lesions on the skin, such as squamous cell cancer can occur while you are taking binimetinib. It is important to have your skin examined before starting this medication, every 2 months while you are taking this medication, and until 6 months after stopping the medication. Signs of squamous cell cancer include sores, warts, or bumps that bleed or do not heal. Signs of melanoma include moles with an irregular shape, border, or colour that are changing shape or are growing. If you notice any of these signs, contact your doctor as soon as possible.

Vision: There have been rare reports of retinal detachment and retinal vein occlusion (blockage of the vein draining the eye) from people taking binimetinib. If you notice any changes in your vision such as coloured dots, halos, or blurred vision, contact your doctor immediately.

Pregnancy: This medication may cause harm to the developing baby if it is taken during pregnancy and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. People who could become pregnant that are taking binimetinib should use an effective method of birth control (e.g., birth control pill, condoms) during treatment and for at least 1 month after the last dose. People whose partners are or may become pregnant should use a barrier method of birth control while taking this medication and for at least 1 week after taking the last dose.

Breast-feeding: It is not known if binimetinib passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: It is likely that seniors will experience more side effects and more severe side effects than younger adults due to decreased liver function. Report any unusual effects to your doctor as soon as possible.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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