Encorafenib
Encorafenib is a targeted cancer medicine (a kinase inhibitor) used with other drugs to treat melanoma, colorectal cancer 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 →
Encorafenib (Braftovi) is a specialist targeted cancer medicine, on the U.S. market since about 2018, that blocks an overactive BRAF protein in melanoma, colorectal cancer and non-small cell lung cancer carrying a BRAF V600E mutation (or V600K in melanoma), always paired with a partner drug. Side effects are common but usually manageable, and tiredness, nausea, joint aches and rash or other skin changes are what most people notice. The one thing to watch is any new or changing spot on your skin, because it can cause new skin cancers. Expect regular checks of your heart, liver and eyes, and report shortness of breath, swelling or vision changes promptly.
Clinical pearls
- It can make hormonal birth control fail, so use a nonhormonal method through two weeks after the last dose.
- Skip grapefruit and grapefruit juice, which raise encorafenib levels, and have every new prescription checked against it.
- If you miss a dose and your next one is less than 12 hours away, skip it; never redose after vomiting.
- Low potassium or magnesium adds to its heart rhythm risk, so expect blood tests for these and review other rhythm-affecting drugs.
Patient information guide A plain-language walkthrough of Encorafenib, written from its FDA label.
What Encorafenib is used for
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Encorafenib treats certain advanced cancers with a BRAF mutation, always as part of a combination.
- Braftovi with binimetinib: unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
- Braftovi with cetuximab and fluorouracil-based chemotherapy: adults with metastatic colorectal cancer with a BRAF V600E mutation.
- Braftovi with cetuximab: adults with metastatic colorectal cancer with a BRAF V600E mutation after prior therapy.
- Braftovi with binimetinib: adults with metastatic non-small cell lung cancer with a BRAF V600E mutation.
- Not for wild-type BRAF melanoma, colorectal cancer or lung cancer.
How Encorafenib works
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Encorafenib is a kinase inhibitor that blocks the BRAF protein, including the mutated BRAF V600E form. In some cancers, this mutated protein stays switched on and drives tumor growth. Blocking it helps slow or shrink the cancer.
Binimetinib blocks another step in the same pathway, and the combination delayed resistance in lab studies. In colorectal cancer, resistance can occur through EGFR, so encorafenib is paired with cetuximab, which targets EGFR.
Encorafenib dosage
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Braftovi comes as capsules taken by mouth once a day, with or without food. The dose depends on the cancer and the partner medicines, so follow your prescriber and the label.
- Don't take a missed dose within 12 hours of your next dose.
- If you vomit after a dose, skip the extra dose and take the next one on schedule.
- Your doctor may lower the dose or pause treatment if side effects occur.
Dosing details from the FDA-approved label
From the Encorafenib 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
- 450 mg (six 75 mg capsules) orally once daily in combination with binimetinib until disease progression or unacceptable toxicity
- Maximum: If binimetinib is withheld, reduce BRAFTOVI to a maximum dose of 300 mg (four 75 mg capsules) once daily until binimetinib is resumed
- May be taken with or without food; dose reductions: first 300 mg once daily, second 225 mg once daily, then permanently discontinue if unable to tolerate 225 mg once daily
- BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
- 450 mg (six 75 mg capsules) orally once daily in combination with binimetinib until disease progression or unacceptable toxicity
- Maximum: If binimetinib is withheld, reduce BRAFTOVI to a maximum dose of 300 mg (four 75 mg capsules) once daily until binimetinib is resumed
- May be taken with or without food; dose reductions: first 300 mg once daily, second 225 mg once daily, then permanently discontinue if unable to tolerate 225 mg once daily
- BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
- 300 mg (four 75 mg capsules) orally once daily until disease progression or unacceptable toxicity in combination with biweekly cetuximab and mFOLFOX6 or biweekly cetuximab and FOLFIRI, or with weekly cetuximab
- May be taken with or without food; dose reductions: first 225 mg once daily, second 150 mg once daily, then permanently discontinue if unable to tolerate 150 mg once 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 BRAFTOVI. ( 2.1 ) • The recommended dose is 450 mg orally once daily in combination with binimetinib. ( 2.2 ) CRC • Confirm the presence of BRAF V600E mutation in plasma or tumor specimens prior to the initiation of BRAFTOVI. ( 2.1 ) • The recommended dose is 300 mg orally once daily in combination with o biweekly cetuximab and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) or cetuximab and FOLFIRI (fluorouracil, leucovorin and irinotecan) ( 2.3 ) o weekly cetuximab ( 2.3 ) NSCLC • Confirm the presence of BRAF V600E mutation in tumor or plasma specimens prior to initiating BRAFTOVI. ( 2.1 ) • The recommended dose is 450 mg orally once daily in combination with binimetinib. ( 2.2 ) Take BRAFTOVI with or without food. ( 2.4 ) 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 BRAFTOVI [see Warnings and Precautions (5.2) , Clinical Studies (14.1) ] . Information on FDA-authorized 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 Colorectal Cancer (CRC) Confirm the presence of a BRAF V600E mutation in plasma or tumor tissue prior to initiating BRAFTOVI [see Warnings and Precautions (5.2) , Clinical Studies (14.2 , 14.3) ]. If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA- authorized tests for the detection of BRAF V600E mutations in CRC 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 BRAFTOVI [see Warnings and Precautions (5.2) , Clinical Studies (14.3) ] . If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA- authorized tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Encorafenib side effects
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Side effects vary by combination. Common ones include:
Common side effects
- Fatigue
- Nausea and vomiting
- Abdominal pain
- Diarrhea or constipation
- Joint pain (arthralgia)
- Rash or other skin changes
- Decreased appetite
- Peripheral neuropathy (nerve problems such as numbness or tingling)
- Hair loss (alopecia)
When to get medical help
- Tell your doctor about any new or changing skin lesions. New skin cancers can occur, so regular skin checks are needed.
- Report signs of heart problems, such as new shortness of breath or swelling. Encorafenib with binimetinib can weaken the heart's pumping (cardiomyopathy).
- Get help for any serious bleeding, including bleeding in the stomach or bowel or in the brain. Major bleeding can occur and has been fatal.
- Call your doctor about new or worsening vision changes, eye pain or redness. These can signal uveitis (eye inflammation).
- Report fainting, dizziness or an irregular heartbeat. Encorafenib can prolong the QT interval (a heart rhythm change).
- Report signs of liver problems. Your doctor will check blood tests for this.
- If you could become pregnant, tell your doctor right away if you think you are pregnant.
Encorafenib warnings and precautions
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- New cancers: skin and other cancers can occur. Skin exams are needed before, during and after treatment.
- Heart muscle weakness: heart function is checked before, at one month, then every 2 to 3 months with binimetinib.
- Bleeding: major and sometimes fatal bleeding can occur.
- Liver problems: liver tests are checked before and during treatment.
- Eye inflammation (uveitis): regular eye checks are needed.
- QT prolongation: electrolytes are monitored and corrected.
- Fetal harm: it can harm an unborn baby.
Encorafenib interactions
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Encorafenib is processed mainly by the CYP3A4 enzyme and also affects it, so many drugs can interact.
- Strong or moderate CYP3A4 inhibitors, including grapefruit juice, raise encorafenib levels and side effects.
- Strong CYP3A4 inducers may make encorafenib less effective.
- Encorafenib can lower levels of other CYP3A4 drugs, including hormonal birth control.
- OATP1B1, OATP1B3 and BCRP substrate drugs may build up and need dose changes.
- Drugs that prolong the QT interval should be avoided.
Interactions listed in the FDA-approved label
From the Encorafenib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong or moderate CYP3A4 inhibitors (including grapefruit juice): Coadministration increases encorafenib plasma concentrations and may increase encorafenib adverse reactions. Avoid coadministration. If unavoidable, reduce the BRAFTOVI dose; after the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the BRAFTOVI dose taken prior to starting the inhibitor.
- Strong CYP3A4 inducers: Coadministration may decrease encorafenib plasma concentrations and may decrease encorafenib efficacy. Avoid coadministration.
- Sensitive CYP3A4 substrates (including hormonal contraceptives): BRAFTOVI is a strong CYP3A4 inducer at steady-state and may decrease plasma concentrations of CYP3A4 substrates, which may reduce their efficacy. Avoid coadministration with CYP3A4 substrates for which a decrease in plasma concentration may lead to reduced efficacy. If it cannot be avoided, see the substrate product labeling for recommendations.
- OATP1B1, OATP1B3, or BCRP substrates: Coadministration can result in increased concentrations of the substrates and may increase their toxicity. Monitor patients closely for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.
- Drugs that prolong the QT interval: BRAFTOVI is associated with dose-dependent QTc interval prolongation. Avoid coadministration of BRAFTOVI with drugs known to prolong the QT/QTc interval.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavoidable, reduce BRAFTOVI dosage. ( 2.6 , 7.1 ) • Strong CYP3A4 inducers: Avoid coadministration. ( 7.1 ) • Sensitive CYP3A4 substrates: Avoid coadministration with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. ( 7.2 ) • Transporters: Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI. ( 7.2 , 12.3 ) 7.1 Effect of Other Drugs on BRAFTOVI Strong or Moderate CYP3A4 Inhibitors Coadministration of BRAFTOVI with a strong or moderate CYP3A4 inhibitor increases encorafenib plasma concentrations [see Clinical Pharmacology (12.3) ] and may increase encorafenib adverse reactions. Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose [see Dosage and Administration (2.6) ] . Strong CYP3A4 Inducers Coadministration of BRAFTOVI with a strong CYP3A4 inducer may decrease encorafenib plasma concentrations [see Clinical Pharmacology (12.3) ] and may decrease encorafenib efficacy. Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers. 7.2 Effect of BRAFTOVI on Other Drugs Sensitive CYP3A4 Substrates BRAFTOVI is a strong CYP3A4 inducer at steady-state. Concomitant use of BRAFTOVI may decrease the plasma concentrations of CYP3A4 substrates (including hormonal contraceptives), [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of these substrates. Avoid the coadministration of BRAFTOVI with CYP3A4 substrates for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
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 Encorafenib
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- Your tumor must test positive for a BRAF mutation.
- Pregnancy: it can cause fetal harm. Use effective nonhormonal birth control during treatment and for 2 weeks after.
- Do not breastfeed during treatment or for 2 weeks after.
- It may affect fertility in men.
- Tell your doctor about heart disease, long QT, or low potassium or magnesium.
- Children: not established as safe or effective.
- Older adults: no overall differences were seen.
- Moderate or severe liver impairment: dosing not established.
Encorafenib overdose
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Encorafenib is 86% bound to proteins in the blood, so hemodialysis is likely to be ineffective for an overdose. If you think you took too much, contact your doctor or poison control right away.
What Encorafenib does in the body
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Encorafenib is linked to dose-dependent QTc prolongation, a change in the heart's electrical rhythm. With binimetinib in melanoma patients, the largest average increase in QTcF was about 18 ms. A dedicated QT study has not been done.
How your body processes Encorafenib
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Encorafenib is well absorbed (at least 86%) and peaks at about 2 hours. A high-fat meal lowers the peak level by 36% but does not change total exposure. The half-life is about 3.5 hours, and steady state is reached within 15 days. It is mainly broken down by CYP3A4 and cleared through both feces and urine.
How to store Encorafenib
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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) . Dispense in original bottle. Protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. 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.
Encorafenib: pharmacist answers to common questions
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.
What is encorafenib used 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?
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Can I take it with my other medicines?
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What about pregnancy and breastfeeding?
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Is Encorafenib available over the counter?
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When was Encorafenib 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 Encorafenib on HelloPharmacist
Encorafenib forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Encorafenib inactive ingredients by manufacturer.
Capsule
How this form is used
- Braftovi is used with binimetinib for BRAF-mutated melanoma and lung cancer.
- Braftovi is used with cetuximab, with or without chemotherapy, for BRAF V600E colorectal cancer.
- Braftovi is taken by mouth once daily, with or without food.
- Braftovi: do not take a missed dose within 12 hours of the next dose.
- Braftovi: if you vomit after a dose, don't take an extra dose.
Encorafenib on the U.S. market: products, makers and brands
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.
1 company lists 1 Encorafenib product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2018. Brand names on the directory include Braftovi; the rest are generics.
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.
How widely Encorafenib is used (Medicaid data)
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 1,601 medications we measure, Encorafenib ranks #1,290 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 | ||||
| 75 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 Encorafenib NDCs →
Encorafenib 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 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.
Encorafenib FDA approval history
How Encorafenib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Encorafenib 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 no Encorafenib recalls since July 2021.
✅No Encorafenib recalls on record since July 2021Source: 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 2049106 1 dose form · 2 strengths
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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.
Encorafenib supply and 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.
Encorafenib brand names
Encorafenib is sold under one brand name in the FDA directory — Braftovi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Encorafenib: manufacturers and labelers
One company lists Encorafenib 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.
Encorafenib drug class (RxNorm)
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.
Sources for this Encorafenib 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 →