Pronunciation:

bin-i-ME-ti-nib

Brand Names:

• Mektovi

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Binimetinib is used in combination with encorafenib to treat melanoma (skin cancer) that has spread or cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. This medicine is also used in combination with encorafenib to treat non-small cell lung cancer (NSCLC) that has spread in patients who have BRAF V600E mutations. Your doctor will use a special test to look for these mutations. Binimetinib belongs to the group of medicines, called antineoplastics (cancer medicines).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of binimetinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of binimetinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism) or
• Eye or vision problems or
• Heart disease (eg, cardiomyopathy, heart failure) or
• Hypertension (high blood pressure) or
• Lung disease or breathing problems or
• Muscle problems—Use with caution. May make these conditions worse.

• Liver disease, moderate or severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For melanoma and non-small cell lung cancer:
    • Adults—45 milligrams (mg) 2 times a day, taken about 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as you remember. If it is 6 hours or less until your next scheduled dose, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 30 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.

This medicine may cause heart problems, including heart failure. Check with your doctor right away if you have chest pain, decreased urine output, an uneven heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or rapid weight gain while using this medicine.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

Check with your doctor right away if blurred vision, loss of vision, or any change in vision occurs during treatment. These could be symptoms of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem (eg, interstitial lung disease, pneumonitis).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause bleeding problems. Tell your doctor if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.

This medicine may cause muscle problems (eg, rhabdomyolysis). Check with your doctor right away if you have dark urine, fever, muscle cramps, spasms, pain, or stiffness, or unusual tiredness or weakness.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision or any other change in vision

chest pain or tightness

coughing up blood

decreased urine output

difficulty in breathing or swallowing

dilated neck veins

dizziness

fever

headache

hoarseness

increased menstrual flow or vaginal bleeding

irregular breathing

irregular heartbeat

irritation

itching, hives, skin rash

joint pain, stiffness, or swelling

nervousness

nosebleed

paralysis

pounding in the ears

prolonged bleeding from cuts

rapid weight gain

red or black, tarry stools

red or dark brown urine

redness of the skin

slow or fast heartbeat

stomach cramps

tenderness

tingling of the hands or feet

trouble seeing

unusual tiredness or weakness

unusual weight gain or loss

watery or bloody diarrhea

Rare

Dark urine

muscle cramps, spasms, pain, or stiffness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

diarrhea

nausea

stomach pain

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.