Binimetinib
Binimetinib is a targeted cancer medicine used to treat certain types of melanoma and non-small cell lung cancer driven by specific BRAF gene mutations.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Binimetinib: Patient Information Guide
A plain-language walkthrough of Binimetinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Binimetinib is a targeted therapy used only for cancers that carry specific BRAF gene mutations, confirmed by testing before treatment begins.
- Mektovi (taken by mouth as a tablet) is used in combination with encorafenib to treat unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
- Mektovi (tablet) is used in combination with encorafenib to treat metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in adult patients, as detected by an FDA-approved test.
⚙️How it works▾
Binimetinib works by blocking two proteins — MEK1 and MEK2 — that are part of a signaling chain (the RAS/RAF/MEK/ERK pathway) that cancer cells use to grow and survive. By interrupting these signals, binimetinib helps slow tumor growth. Its partner drug, encorafenib, blocks a different protein in the same chain (BRAF), so the two-drug combination attacks the pathway at two separate points, producing stronger anti-tumor effects than either drug alone.
Importantly, research in lab and animal models showed that the combination also delays the development of resistance — meaning cancer cells take longer to find a workaround — compared to using either drug by itself.
💊How it's taken▾
Mektovi is taken as an oral tablet twice daily, roughly 12 hours apart, and can be taken with or without food. It is always used together with encorafenib and should not be taken alone.
- If you miss a dose and your next scheduled dose is within 6 hours, skip the missed dose and take the next one on time.
- If you vomit after swallowing a dose, do not take an extra tablet — continue with your next scheduled dose.
- Patients with moderate or severe liver impairment may need a lower dose, as determined by their prescriber.
🤒Side effects — in detail▾
The most common side effects reported with Mektovi used together with encorafenib include:
- Fatigue or weakness
- Nausea
- Diarrhea
- Vomiting
- Abdominal (belly) pain
- Visual changes or blurred vision
- Musculoskeletal (muscle and joint) pain
- Constipation
- Rash
- Shortness of breath
More serious reactions — including heart muscle problems, blood clots, serious eye damage, liver injury, muscle breakdown, lung inflammation, and significant bleeding — have been reported and require prompt medical attention if you notice new or worsening symptoms.
⚠️Warnings & precautions▾
- Heart problems (cardiomyopathy): Decreases in heart pumping function have been reported. Your doctor will monitor your heart with imaging tests before and during treatment. People with a baseline ejection fraction below 50% have not been established as safe to treat with Mektovi.
- Blood clots (venous thromboembolism): Deep vein thrombosis and pulmonary embolism (clot in the lung) can occur. Tell your doctor immediately if you have leg swelling, pain, or sudden shortness of breath.
- Eye toxicity: Fluid under the retina (serous retinopathy), blocked retinal blood vessels (retinal vein occlusion), and eye inflammation (uveitis) have occurred. Report any vision changes right away, and have regular eye exams.
- Bleeding: Serious and sometimes fatal bleeding events have been reported, including gastrointestinal and brain bleeding.
- Liver injury (hepatotoxicity): Liver enzyme elevations can occur; liver labs are monitored monthly.
- Muscle breakdown (rhabdomyolysis): Muscle enzyme levels are monitored during treatment. Report muscle pain, weakness, or dark urine promptly.
- Lung inflammation (interstitial lung disease): New or worsening breathing symptoms should be reported and evaluated.
- New cancers: New skin and other cancers can develop during treatment with Mektovi and encorafenib. Skin monitoring before, during, and after treatment is recommended.
- Fetal harm: Mektovi can seriously harm an unborn baby. Effective contraception is required during treatment and for 30 days after the last dose.
🔀What it interacts with▾
The FDA label for Mektovi states that no clinically important drug interactions have been observed. However, there are some pharmacokinetic notes worth knowing:
- Binimetinib is processed through certain transport proteins (P-glycoprotein and BCRP) — medicines that strongly affect these pathways could theoretically alter its levels, though no clinically meaningful interactions have been identified in studies.
- Stomach acid-reducing medicines (such as proton pump inhibitors) do not meaningfully affect how much binimetinib your body absorbs.
- Binimetinib does not meaningfully affect the breakdown of many other medications processed by common liver enzymes (CYP3A4, CYP2D6, CYP2C9, CYP1A2).
- No meaningful interaction was seen when Mektovi is taken together with its required partner, encorafenib.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Your cancer must be confirmed to have a BRAF V600E or V600K mutation (for melanoma) or a BRAF V600E mutation (for NSCLC) by an FDA-approved test before starting Mektovi.
- Tell your doctor if you are pregnant, may become pregnant, or are breastfeeding — Mektovi can harm an unborn baby, and breastfeeding is not recommended during treatment or for 3 days after the last dose.
- Females of reproductive potential must use effective contraception during treatment and for 30 days after the final dose; a pregnancy test is done before starting.
- Tell your doctor if you have reduced heart function or a history of heart disease — heart ejection fraction below 50% has not been established as safe for treatment.
- Tell your doctor if you have moderate or severe liver disease — the dose may need to be reduced.
- Tell your doctor about any history of eye problems, retinal vein occlusion, glaucoma, or hypercoagulability (blood that clots too easily).
- Safety and effectiveness have not been established in children.
- Older adults (65 and over) have received Mektovi in trials with no overall differences in safety or effectiveness compared to younger patients, but close monitoring is still important.
🚑If you take too much▾
There is limited information on what an overdose of binimetinib would look like. Because binimetinib binds tightly to proteins in the blood (about 97%), hemodialysis (a kidney-filtering procedure sometimes used in poisoning) is unlikely to remove it effectively. If you think you or someone else has taken too much, contact poison control or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
At the recommended twice-daily dosing, Mektovi was not found to cause meaningful QT prolongation — a type of heart rhythm change that some cancer medicines can cause and that can increase the risk of abnormal heartbeats. This was assessed through cardiac monitoring studies and is considered reassuring from a heart-rhythm safety standpoint.
🔬Pharmacokinetics — how your body processes it▾
After twice-daily dosing, binimetinib reaches a steady level in the body with about 1.5-fold accumulation over time. Patients with moderate or severe liver impairment can have roughly twice the drug exposure compared to those with normal liver function, which is why a dose adjustment is recommended for those patients. In people with severe kidney impairment, no clinically important changes in drug exposure were observed. Stomach acid-reducing medicines do not affect how much binimetinib is absorbed, and smoking does not meaningfully change drug levels either.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .
📄 Written from Binimetinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Binimetinib
55 supplements and herbal products have documented interactions with Binimetinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 42
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Binimetinib — the kind of thing our pharmacy team would talk through with you at the counter.
Why does my doctor say I have to take two medicines — Mektovi and encorafenib — together? ▾
What side effects should I just manage at home versus call the doctor about right away? ▾
How important is it to have my eyes checked while I'm on this medicine? ▾
I'm a woman of childbearing age. What do I need to know about pregnancy while taking this? ▾
Why does my heart need to be checked regularly while I'm on this treatment? ▾
What happens if I accidentally miss a dose or vomit after taking it? ▾
Is Binimetinib available over the counter? ▾
When was Binimetinib first available? ▾
Who makes Binimetinib? ▾
💬 Answers drafted from Binimetinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Binimetinib comes
Binimetinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Mektovi tablets are used with encorafenib to treat unresectable or metastatic melanoma with a BRAF V600E or V600K mutation confirmed by an FDA-approved test.
- Mektovi tablets are used with encorafenib to treat metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation confirmed by an FDA-approved test, in adults.
- Mektovi tablets are taken by mouth twice daily, approximately 12 hours apart, with or without food.
- Mektovi tablets must always be taken together with encorafenib — never as a stand-alone treatment.
- If a Mektovi dose is missed and the next dose is within 6 hours, skip the missed dose and resume the normal schedule.
- If vomiting occurs after taking a Mektovi tablet, do not take a replacement dose — continue with the next scheduled dose.
📊 Binimetinib across the U.S. market
How Binimetinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Binimetinib is used
A general measure of how commonly Binimetinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Binimetinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Binimetinib prescribed? Of the 1,594 medications we measure, Binimetinib ranks #1,275 by Medicaid prescriptions — more than 20% of them.
Utilization by Binimetinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
binimetinib 15 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049127
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Binimetinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Binimetinib NDCs with Medicaid activity.
🔍 Compare Binimetinib products
A representative set of FDA-listed product records for Binimetinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 15 mg | Oral | Array BioPharma Inc. × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Valary Lab Private Limited | BULK INGREDIENT | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Binimetinib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Binimetinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Binimetinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Binimetinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2049122 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 2049126In current FDA listingsClinical drug / strength (SCD) 15 MGRxCUI 2049127
Look up RxCUI 2049122 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Binimetinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Binimetinib belongs to the Mitogen-activated protein kinase (MEK) inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Array BioPharma Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.