Mektovi

Binimetinib is used to treat a type of skin cancer (melanoma). Binimetinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking binimetinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily (about 12 hours apart).

If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Nausea, vomiting, diarrhea, tiredness, abdominal pain, constipation, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, black/bloody stools, vomit that contains blood or looks like coffee grounds, muscle pain/tenderness/weakness, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), vision changes (such as blurred vision, decreased vision, seeing halos/colored dots), eye pain/swelling/redness, signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking binimetinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, high blood pressure, heart disease (such as heart failure), eye problems, kidney problems, liver problems.

This drug may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using binimetinib. Binimetinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 30 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 3 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as BRAF gene testing, heart/kidney/liver function, skin/eye exams, CPK levels, complete blood count) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.