Encorafenib
Encorafenib (Braftovi) is a targeted cancer medicine used to treat certain types of metastatic melanoma, metastatic colorectal cancer, and metastatic non-small cell lung cancer that carry a specific BRAF gene 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 →
📖 Encorafenib: Patient Information Guide
A plain-language walkthrough of Encorafenib — 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▾
Encorafenib (Braftovi) is a targeted cancer medicine used only in patients whose tumor carries a specific BRAF gene mutation, confirmed by an FDA-authorized test before starting treatment.
- Braftovi (combined with binimetinib) treats unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Braftovi (combined with cetuximab and fluorouracil-based chemotherapy — mFOLFOX6 or FOLFIRI) treats adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
- Braftovi (combined with cetuximab alone) treats adult patients with mCRC with a BRAF V600E mutation after prior therapy
- Braftovi (combined with binimetinib) treats adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation
- Braftovi is not for use in melanoma, colorectal cancer, or NSCLC that does not carry a BRAF mutation (wild-type BRAF)
⚙️How it works▾
Encorafenib is a kinase inhibitor that works by blocking a mutated protein called BRAF V600E. When the BRAF gene has a V600E (or V600K) mutation, it produces a protein that stays permanently switched on — constantly sending signals that tell cancer cells to grow and divide. Encorafenib attaches to that faulty protein and shuts down the signal, slowing or stopping tumor growth. It is almost always paired with a second drug (binimetinib or cetuximab) that blocks a different point in the same signaling chain, making the two-drug combination more powerful than either drug alone.
In colorectal cancer specifically, cancer cells can sometimes find a workaround called EGFR-mediated pathway activation — a back door that lets them resist BRAF inhibitors. Combining encorafenib with cetuximab (an EGFR blocker) helps close that back door. When used with binimetinib, the combination also delays the development of drug resistance compared to encorafenib alone.
💊How it's taken▾
Braftovi comes as capsules taken by mouth once a day. It can be taken with or without food. The dose your prescriber chooses depends on which cancer is being treated and which other medicines are in your regimen — so doses differ across indications and may be adjusted if side effects occur or if certain other drugs are added to your regimen.
- Take Braftovi at roughly the same time each day
- If you miss a dose and your next dose is due within 12 hours, skip the missed dose
- If you vomit after taking a dose, do not take an extra one — just take your next scheduled dose as planned
- Never stop or adjust your dose on your own; always talk to your care team first
🤒Side effects — in detail▾
The most common side effects vary somewhat depending on which combination you are receiving, but across regimens they frequently include:
- Fatigue (tiredness)
- Nausea and vomiting
- Diarrhea
- Abdominal (stomach) pain
- Joint pain (arthralgia)
- Rash or skin changes
- Decreased appetite
- Headache or dizziness
More serious reactions that require prompt medical attention include new skin growths or moles, unusual bleeding, vision changes, yellowing of the skin or eyes, chest pain or shortness of breath, and heart rhythm changes. Do not wait to contact your care team if any of these occur.
⚠️Warnings & precautions▾
- New cancers: Encorafenib can trigger new skin cancers (squamous cell carcinoma, basal cell carcinoma, new melanoma) and potentially other cancers. Regular dermatology exams — before, during, and for 6 months after treatment — are required.
- Heart problems: The medicine can weaken the heart's pumping ability (cardiomyopathy) and affect heart rhythm (QT prolongation, which can lead to dangerous arrhythmias). Heart function must be checked before starting and regularly during treatment.
- Serious bleeding: Hemorrhage — including potentially fatal intracranial and gastrointestinal bleeding — has been reported. Report any unusual bleeding right away.
- Liver toxicity: Liver enzyme levels can rise significantly. Liver blood tests are monitored before and throughout treatment.
- Eye inflammation (uveitis): Inflammation inside the eye can occur. Report any vision changes, eye pain, or redness immediately.
- Fetal harm: Encorafenib can seriously harm an unborn baby. Females who could become pregnant must use effective non-hormonal contraception during treatment and for 2 weeks after the last dose.
- Tumor promotion in BRAF wild-type tumors: If your cancer does not carry a BRAF mutation, this drug can actually stimulate tumor growth — which is why mutation testing before starting is mandatory.
🔀What it interacts with▾
Encorafenib interacts with several types of medicines — always give your full medication list to your care team before starting:
- Strong or moderate CYP3A4 inhibitors (some antifungals, certain antibiotics, HIV medicines, and grapefruit juice): raise encorafenib blood levels, increasing side effect risk — avoid or require a dose adjustment
- Strong CYP3A4 inducers (some anti-seizure drugs, rifampin): lower encorafenib blood levels and can make it less effective — avoid these combinations
- Hormonal contraceptives (pills, patches, rings): encorafenib reduces their effectiveness — switch to a non-hormonal method
- QT-prolonging drugs (certain heart, antibiotic, or antipsychotic medicines): combining with encorafenib raises the risk of dangerous heart rhythm changes — avoid if possible
- OATP1B1, OATP1B3, or BCRP substrate drugs (some statins and other medicines): encorafenib can push these drugs to higher levels in the blood, increasing their toxicity — dose adjustments may be needed
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▾
- Pregnancy: Encorafenib can cause serious harm to an unborn baby — tell your doctor immediately if you are pregnant or become pregnant during treatment
- Contraception: Females who could become pregnant must use a reliable non-hormonal contraceptive method during treatment and for 2 weeks after the last dose; hormonal methods are not reliable with this medicine
- Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose due to potential serious harm to the infant
- Male fertility: Encorafenib may impair fertility in males; discuss this with your doctor before starting if this is a concern
- Heart conditions: Patients with heart rhythm problems, low potassium or magnesium, uncontrolled heart failure, or QT prolongation require especially close monitoring
- Liver impairment: Mild liver impairment (Child-Pugh Class A) does not require a dose change; a safe dose has not been established for moderate or severe liver impairment
- Kidney impairment: Mild to moderate kidney impairment does not require a dose adjustment; inform your care team of any kidney issues
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults: Patients 65 and older have been included in trials with no overall difference in safety or effectiveness, but close monitoring remains important
🚑If you take too much▾
Because encorafenib binds strongly to proteins in the blood (about 86% protein-bound), hemodialysis (a blood-filtering procedure) is not expected to effectively remove it from the body in the event of an overdose. If an overdose is suspected, contact a poison control center or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
Encorafenib causes dose-dependent QTc interval prolongation — meaning it can lengthen a specific part of the heart's electrical cycle in a way that, at larger changes, can raise the risk of dangerous arrhythmias. In a clinical study of patients with melanoma taking Braftovi in combination with binimetinib at the recommended dose, the average QTc change from baseline was about 18 milliseconds. Electrolyte levels (especially potassium and magnesium) are monitored and corrected throughout treatment because imbalances can amplify this effect.
🔬Pharmacokinetics — how your body processes it▾
After taking Braftovi by mouth, peak blood levels are reached in about 2 hours, and at least 86% of the dose is absorbed. The medicine is processed mainly by a liver enzyme called CYP3A4 (and to a smaller extent by CYP2C19 and CYP2D6), which is why drugs that inhibit or induce these enzymes can significantly alter encorafenib levels. The drug's half-life — the time it takes for blood levels to fall by half — is about 3.5 hours, and steady levels in the body are reached within about 15 days of daily dosing. Roughly equal portions of the drug are eliminated through stool and urine.
📦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) . Dispense in original bottle. Protect from moisture.
📄 Written from Encorafenib’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 Encorafenib
151 supplements and herbal products have documented interactions with Encorafenib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 104
- Minor · 39
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 Encorafenib — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I need a genetic test before starting this medicine? ▾
Why am I being given two or three medicines at the same time? Can't I just take Braftovi alone? ▾
What side effects are most common, and when should I call my doctor? ▾
Can I take my regular medicines, vitamins, or supplements while on Braftovi? ▾
Is it safe to become pregnant while taking this medicine? ▾
What does the regular heart monitoring involve, and why is it needed? ▾
Is Encorafenib available over the counter? ▾
When was Encorafenib first available? ▾
Who makes Encorafenib? ▾
💬 Answers drafted from Encorafenib’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 Encorafenib comes
Encorafenib 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.
Capsule
How this form is used
- Braftovi capsules are used in combination with binimetinib to treat unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
- Braftovi capsules are used in combination with cetuximab and fluorouracil-based chemotherapy (mFOLFOX6 or FOLFIRI) to treat metastatic colorectal cancer with a BRAF V600E mutation
- Braftovi capsules are used in combination with cetuximab alone to treat metastatic colorectal cancer with a BRAF V600E mutation after prior therapy
- Braftovi capsules are used in combination with binimetinib to treat metastatic non-small cell lung cancer with a BRAF V600E mutation
- Braftovi capsules are taken by mouth once daily, with or without food
- Braftovi capsules should be swallowed as directed — do not take a missed dose if the next dose is due within 12 hours
- If vomiting occurs after taking Braftovi, do not take an extra dose; continue with the next scheduled dose
- Braftovi capsules are taken until disease progression or unacceptable side effects occur, as directed by your prescriber
📊 Encorafenib across the U.S. market
How Encorafenib 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 (4) — 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 Encorafenib is used
A general measure of how commonly Encorafenib 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 Encorafenib 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 Encorafenib prescribed? Of the 1,594 medications we measure, Encorafenib ranks #1,289 by Medicaid prescriptions — more than 19% of them.
Utilization by Encorafenib 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.
encorafenib 75 MG Oral Capsule
Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049119
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 Encorafenib, 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 2 of 10 listed Encorafenib NDCs with Medicaid activity.
🔍 Compare Encorafenib products
A representative set of FDA-listed product records for Encorafenib — 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 |
|---|---|---|---|---|
| 💊Capsule | ||||
| 50 mg | — | Ardena US, LLC | EXPORT ONLY | View NDC → |
| 50 mg | — | Ardena US, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg | — | Ardena US, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg | — | Ardena US, LLC | EXPORT ONLY | View NDC → |
| 75 mg | Oral | Array BioPharma Inc. × 3 listings | NDA | View NDC → |
| 50 mg | — | Catalent Pharma Solutions, LLC × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 75 mg | — | Catalent Pharma Solutions, LLC × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Finorga | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Valary Lab Private Limited | BULK INGREDIENT | View NDC → |
Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Encorafenib 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 Encorafenib — 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 Encorafenib 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 Encorafenib 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 2049106 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 2049110In current FDA listings
Look up RxCUI 2049106 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 Encorafenib 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
Encorafenib belongs to the B-Raf serine-threonine kinase (BRAF) 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.