Binimetinib
Binimetinib is a targeted cancer medicine (a MEK inhibitor) taken with encorafenib to treat melanoma and non-small cell lung cancer that carry a specific BRAF mutation.
🧬 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 (Mektovi) is a specialist targeted cancer medicine, on the U.S. market since about 2018. It blocks two signaling proteins, MEK1 and MEK2, and is always paired with encorafenib (a BRAF blocker) for melanoma or non-small cell lung cancer carrying a tested BRAF mutation. For a cancer drug it is usually manageable, though most people notice tiredness, nausea or diarrhea, and some get blurry vision. Report vision changes, bleeding, signs of a clot (a swollen painful leg, chest pain) or new breathlessness or cough promptly, and expect regular checks of your heart, eyes, liver and muscles throughout treatment.
Clinical pearls
- Take it twice a day about 12 hours apart, with or without food, alongside your encorafenib doses.
- If either binimetinib or encorafenib runs out or is paused, check with your oncology team before taking the other alone.
- Use effective birth control during treatment and for 30 days after the last dose, and avoid breastfeeding until 3 days after.
- Check your skin regularly and point out any new growth or changing mole, since new skin cancers can appear during treatment.
Patient information guide A plain-language walkthrough of Binimetinib, written from its FDA label.
What Binimetinib is used for
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Binimetinib is used with encorafenib to treat certain BRAF-mutated cancers.
- Mektovi: unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
- Mektovi: metastatic non-small cell lung cancer in adults with a BRAF V600E mutation, as detected by an FDA-approved test.
How Binimetinib works
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Binimetinib reversibly blocks MEK1 and MEK2, proteins that help pass growth signals along the RAS/RAF/MEK/ERK pathway. In BRAF-mutated cancers this pathway can stay switched on and drive tumor growth.
Encorafenib blocks a different protein in the same pathway. In lab and animal studies, the combination shrank tumor growth more and delayed resistance compared with either drug alone.
Binimetinib dosage
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Mektovi tablets are taken by mouth twice a day, about 12 hours apart, with or without food. They are taken along with encorafenib.
- Do not take a missed dose within 6 hours of the next dose.
- If you vomit after a dose, do not take an extra one. Take the next dose as scheduled.
- Your doctor may lower the dose for side effects or for moderate to severe liver impairment.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Binimetinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma
- 45 mg orally taken twice daily, approximately 12 hours apart, in combination with encorafenib until disease progression or unacceptable toxicity
- May be taken with or without food. Do not take a missed dose within 6 hours of the next dose. Do not take an additional dose if vomiting occurs.
- BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC)
- 45 mg orally taken twice daily, approximately 12 hours apart, in combination with encorafenib until disease progression or unacceptable toxicity
- May be taken with or without food. Do not take a missed dose within 6 hours of the next dose. Do not take an additional dose if vomiting occurs.
- Moderate (total bilirubin greater than 1.5 and less than or equal to 3 × ULN and any AST) or severe (total bilirubin levels greater than 3 × ULN and any AST) hepatic impairment
- 30 mg orally taken twice daily
- Hepatic impairment dose adjustment
- Dose reduction for adverse reactions (first dose reduction)
- 30 mg orally twice daily
- Permanently discontinue if unable to tolerate MEKTOVI 30 mg orally twice daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Melanoma • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of MEKTOVI. ( 2.1 ) • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. ( 2.2 ) • For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily. ( 2.4 , 8.6 ) NSCLC • Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI. ( 2.1 ) • The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take MEKTOVI with or without food. ( 2.2 ) 2.1 Patient Selection BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating MEKTOVI [see Clinical Studies (14) ] . Information on FDA-approved tests for the detection of BRAF V600E and V600K mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics . BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) Confirm the presence of a BRAF V600E mutation in tumor or plasma specimens prior to initiating MEKTOVI [see Clinical Studies (14.2) ] . If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics . 2.2 Recommended Dosage and Administration The recommended dosage of MEKTOVI is 45 mg orally taken twice daily, approximately 12 hours apart, in combination with encorafenib until disease progression or unacceptable toxicity. Refer to the encorafenib prescribing information for recommended encorafenib dosing information. MEKTOVI may be taken with or without food [see Clinical Pharmacology (12.3) ] . Do not take a missed dose of MEKTOVI within 6 hours of the next dose of MEKTOVI. Do not take an additional dose if vomiting occurs after MEKTOVI administration but continue with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions If encorafenib is permanently discontinued, discontinue MEKTOVI. Dose reductions for adverse reactions associated with MEKTOVI are presented in Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Binimetinib side effects
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The most common side effects with encorafenib include:
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
- Constipation
- Visual changes (more often reported in lung cancer)
- Muscle and joint pain, cough, shortness of breath and rash (lung cancer)
- Visual impairment, rash, cough, shortness of breath and muscle pain (more common in lung cancer)
When to get medical help
- Call your doctor right away for any new vision changes, blurred vision or sudden vision loss. Eye problems like fluid under the retina, retinal vein blockage and uveitis (eye inflammation) can occur.
- Get help for signs of a blood clot, such as a swollen painful leg, chest pain or sudden shortness of breath.
- Report bleeding promptly, including black or bloody stools, blood in urine or coughing up blood. Serious and fatal bleeding has occurred.
- Tell your doctor about new or worsening shortness of breath or cough, which could signal lung inflammation (interstitial lung disease).
- Report swelling, tiredness or breathlessness that could signal heart muscle weakness (cardiomyopathy).
- Report severe muscle pain, weakness or dark urine, which may signal rhabdomyolysis (muscle breakdown).
- Tell your doctor about any new skin growths or other new cancers.
- Tell your doctor about signs of liver problems, since liver tests need regular monitoring.
Binimetinib warnings and precautions
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- Heart muscle weakness: pumping strength is checked before treatment, after one month, then every 2 to 3 months.
- Blood clots: deep vein clots and lung clots can occur.
- Eye problems: serous retinopathy, retinal vein occlusion and uveitis. Regular eye exams are needed.
- Bleeding: major and sometimes fatal bleeding, including in the brain.
- Lung inflammation, liver injury and muscle breakdown: monitored with symptoms and blood tests.
- New cancers: skin and other cancers can appear, so you will be monitored.
- Pregnancy: can cause fetal harm.
Binimetinib interactions
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The label reports no clinically important drug interactions with Mektovi.
- Encorafenib is taken with it by design and did not change binimetinib levels.
- Smoking and an acid-reducing medicine (rabeprazole) did not meaningfully change levels.
Interactions listed in the FDA-approved label
From the Binimetinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drug interactions (general): No clinically important drug interactions have been observed with MEKTOVI.
Read the label’s full interactions text
7 DRUG INTERACTIONS No clinically important drug interactions have been observed with MEKTOVI.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Binimetinib
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- Pregnancy: can harm an unborn baby. Pregnancy status is checked first, and effective birth control is advised during treatment and for 30 days after the last dose.
- Breastfeeding: do not breastfeed during treatment and for 3 days after the last dose.
- Heart: safety is not established if ejection fraction is low.
- Eyes: safety is not established with a history of retinal vein occlusion or risk factors like uncontrolled glaucoma.
- Liver: a lower dose is used in moderate or severe impairment.
- Children: safety and effectiveness not established.
- Older adults: no overall differences in safety or effectiveness.
Binimetinib overdose
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Binimetinib is highly bound to proteins in the blood, so hemodialysis is likely to be ineffective for an overdose. If you take too much, contact your doctor or poison control right away.
What Binimetinib does in the body
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At the usual dose, no clinically meaningful QT prolongation (a heart rhythm timing change) was seen.
How your body processes Binimetinib
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Binimetinib was studied in healthy people and in patients with solid tumors. With twice-daily dosing, levels build up about 1.5-fold. Moderate or severe liver impairment roughly doubled exposure, while severe kidney impairment did not change it meaningfully. It is a substrate of the transporters P-glycoprotein and BCRP.
How to store Binimetinib
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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 the FDA-approved label with AI and reviewed by our pharmacy team. 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.
Binimetinib: pharmacist answers to common questions
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.
What is this medicine for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Will I need tests while on it?
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Is it safe in pregnancy or while breastfeeding?
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Is Binimetinib available over the counter?
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When was Binimetinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Binimetinib on HelloPharmacist
Binimetinib forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Binimetinib inactive ingredients by manufacturer.
Tablet
How this form is used
- Mektovi is used with encorafenib for BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.
- Mektovi is used with encorafenib for BRAF V600E mutation-positive metastatic non-small cell lung cancer in adults.
- Mektovi is taken by mouth twice daily, about 12 hours apart, with or without food.
- Do not take a missed Mektovi dose within 6 hours of the next dose.
- If you vomit after taking Mektovi, do not take an extra dose; take the next scheduled dose.
- Mektovi is stopped if encorafenib is permanently discontinued.
Binimetinib on the U.S. market: products, makers and brands
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.
1 company lists 1 Binimetinib product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Mektovi; the rest are generics.
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.
How widely Binimetinib is used (Medicaid data)
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 1,601 medications we measure, Binimetinib ranks #1,277 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. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Binimetinib NDCs →
Binimetinib side effects reported to the 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.
Binimetinib FDA approval history
How Binimetinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Binimetinib 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.
The FDA’s enforcement reports list one Binimetinib recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02 Lots: Lot W054586A, EXP 03/2026 FDA record D-0532-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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
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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.
Binimetinib supply and 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.
Binimetinib brand names
Binimetinib is sold under one brand name in the FDA directory — Mektovi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Binimetinib: manufacturers and labelers
One company lists Binimetinib products with the FDA. By number of product records, the largest are Array BioPharma Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Binimetinib drug class (RxNorm)
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.
Sources for this Binimetinib page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Array BioPharma Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →