Vemurafenib
Vemurafenib is a targeted cancer pill used to treat melanoma that has spread or can't be removed by surgery, and Erdheim-Chester disease, in people whose tumors 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 →
Vemurafenib (Zelboraf) is a specialist targeted cancer drug that blocks a mutated, switched-on BRAF protein, used for advanced melanoma and for the rare blood-cell disorder Erdheim-Chester disease when testing confirms the mutation; it has been on the market since about 2011 and is not available as a generic. Side effects are common, mainly joint pain, tiredness, rash, itching and hair loss, and sunburn comes on unusually fast. Watch above all for new skin growths, because it can cause new skin cancers; report any new spot, changing mole or non-healing sore. Expect regular ECGs (heart tracings) plus liver, kidney and electrolyte blood tests.
Clinical pearls
- Its sun sensitivity can reach you through car and home windows, so use SPF 30 or higher sunscreen, lip balm and covering clothing.
- Swallow the tablets whole without crushing or chewing; food makes no difference, so choose consistent times you will remember.
- Tell every prescriber you take it, since rifampin, carbamazepine, phenytoin and tizanidine interact, and digoxin levels can climb.
- Report fainting, dizziness or a racing or irregular heartbeat promptly, as these can signal QT prolongation, a heart rhythm problem.
Patient information guide A plain-language walkthrough of Vemurafenib, written from its FDA label.
What Vemurafenib is used for
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Vemurafenib is used for cancers and related conditions driven by BRAF mutations.
- Zelboraf tablets treat unresectable or metastatic melanoma with a BRAF V600E mutation found by an FDA-approved test.
- Zelboraf tablets treat Erdheim-Chester disease with a BRAF V600 mutation.
- It is not for melanoma with wild-type (non-mutated) BRAF.
How Vemurafenib works
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Vemurafenib is an oral kinase inhibitor. It blocks mutated forms of the BRAF protein, including BRAF V600E. This mutation keeps BRAF constantly active, which makes cells multiply without normal growth signals.
Blocking the overactive protein gives vemurafenib anti-tumor effects. In BRAF wild-type cells, BRAF inhibitors can instead increase cell growth, which is why mutation testing comes first.
Vemurafenib dosage
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Zelboraf is taken by mouth as tablets about every 12 hours, with or without food. Swallow them whole.
- A missed dose can be taken up to 4 hours before the next dose.
- If you vomit, don't take an extra dose. Wait for the next scheduled one.
- Your doctor may lower the dose or pause treatment if side effects are intolerable.
Follow your prescriber's instructions and the label.
Dosing details from the FDA-approved label
From the Vemurafenib 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.
- Melanoma with BRAF V600E mutation (recommended dose)
- 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal
- Treat until disease progression or unacceptable toxicity occurs
- A missed dose can be taken up to 4 hours prior to the next dose; do not take an additional dose if vomiting occurs; do not crush or chew the tablets
- Dose modification: first appearance of intolerable Grade 2 or Grade 3 adverse reactions
- 720 mg twice daily after withholding and recovery to Grade 0-1
- Do not dose reduce to below 480 mg twice daily
- Dose modification: second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions, or first appearance of Grade 4 adverse reaction (if clinically appropriate)
- 480 mg twice daily after withholding and recovery to Grade 0-1
- Do not dose reduce to below 480 mg twice daily
- Concomitant use of a strong CYP3A4 inducer that is unavoidable
- Increase the dose of ZELBORAF by 240 mg (one tablet) as tolerated
- After discontinuation of the inducer for two weeks, resume the ZELBORAF dose taken prior to starting the inducer
- New primary cutaneous malignancies
- No dose modifications are recommended
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with ZELBORAF. ( 2.1 ) Recommended dose: 960 mg orally twice daily taken approximately 12 hours apart with or without a meal. ( 2.2 ) 2.1 Patient Selection for Treatment of Melanoma Confirm the presence of BRAF V600E mutation in melanoma tumor specimens prior to initiation of treatment with ZELBORAF [see Warnings and Precautions (5.2) ] . Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dose The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal. A missed dose can be taken up to 4 hours prior to the next dose. Treat patients with ZELBORAF until disease progression or unacceptable toxicity occurs. Do not take an additional dose if vomiting occurs after ZELBORAF administration, but continue with the next scheduled dose. Do not crush or chew the tablets. 2.3 Dose Modifications For New Primary Cutaneous Malignancies: No dose modifications are recommended. For Other Adverse Reactions: Permanently discontinue ZELBORAF for any of the following: Grade 4 adverse reaction, first appearance (if clinically appropriate) or second appearance QTc prolongation > 500 ms and increased by > 60 ms from pre-treatment values [see Warnings and Precautions (5.5) ] Withhold ZELBORAF for NCI-CTCAE (v4.0) intolerable Grade 2 or greater adverse reactions. Upon recovery to Grade 0–1, restart ZELBORAF at a reduced dose as follows: 720 mg twice daily for first appearance of intolerable Grade 2 or Grade 3 adverse reactions 480 mg twice daily for second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions or for first appearance of Grade 4 adverse reaction (if clinically appropriate) Do not dose reduce to below 480 mg twice daily. 2.4 Dose Modification for Strong CYP3A4 Inducers Avoid concomitant use of strong CYP3A4 inducers during treatment with ZELBORAF [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] . If concomitant use of a strong CYP3A4 inducer is unavoidable, increase the dose of ZELBORAF by 240 mg (one tablet) as tolerated.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Vemurafenib side effects
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The most common side effects in melanoma studies were:
Common side effects
- Joint pain
- Rash
- Hair loss
- Tiredness
- Sun sensitivity or sunburn
- Nausea
- Itching
- Skin growths (papillomas)
When to get medical help
- Call your doctor if you notice a new skin growth, a changing mole or a sore that won't heal. This medicine can cause new skin cancers.
- Get emergency help for a severe allergic reaction, such as widespread rash, swelling or faintness.
- Get help right away for a severe skin reaction with blistering or peeling.
- Report fainting, a racing or irregular heartbeat or dizziness. These can be signs of a heart rhythm problem (QT prolongation).
- Tell your doctor about eye pain, redness, blurry vision or light sensitivity, which may be uveitis (eye inflammation).
- Report yellowing of the skin or eyes, or other signs of liver problems.
- Tell your doctor about thickening or tightening of the skin in the palm or foot, which can limit movement.
In Erdheim-Chester disease, QT prolongation on ECG was also common. Act quickly on new skin cancers, severe allergic or skin reactions, heart rhythm symptoms, eye problems and signs of liver trouble.
Vemurafenib warnings and precautions
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- New cancers: skin cancers are common, and other cancers can occur. Get regular skin exams.
- Serious allergic and skin reactions: including anaphylaxis, DRESS, Stevens-Johnson syndrome and toxic epidermal necrolysis. Treatment is stopped permanently for severe cases.
- QT prolongation: can lead to dangerous heart rhythms. ECG and electrolytes are checked regularly.
- Liver injury: blood tests are done before treatment and monthly.
- Kidney problems: creatinine is checked before and during treatment.
- Sun sensitivity, eye inflammation (uveitis), radiation sensitization and recall, and Dupuytren's contracture (thickening of tissue in the palm) can also occur.
- Pregnancy: can harm a fetus.
Vemurafenib interactions
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Several drugs can change vemurafenib levels or be affected by it.
- Strong CYP3A4 inhibitors: raise vemurafenib levels and may increase toxicity.
- Strong CYP3A4 inducers (phenytoin, carbamazepine, rifampin): lower levels and may reduce effectiveness.
- QT-prolonging drugs: add to heart rhythm risk.
- Tizanidine and other CYP1A2 drugs: levels can rise.
- Digoxin and other P-gp drugs: levels can rise.
- Ipilimumab: liver tests rose in most patients using both.
Interactions listed in the FDA-approved label
From the Vemurafenib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors: Coadministration increased vemurafenib plasma concentrations and may lead to increased toxicity. Avoid coadministration; if unavoidable, consider dose reduction of ZELBORAF, if clinically indicated.
- Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin): Rifampin, a strong CYP3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy. Avoid coadministration and replace these drugs with alternatives when possible; if unavoidable, increase the ZELBORAF dose by 240 mg (one tablet) as tolerated.
- CYP1A2 substrates (e.g., tizanidine): Coadministration with tizanidine, a sensitive CYP1A2 substrate, increased tizanidine systemic exposure by 4.7-fold. Avoid use with CYP1A2 substrates with a narrow therapeutic window; if unavoidable, monitor closely for toxicities and consider dose reduction of the CYP1A2 substrate.
- Ipilimumab: Increases in transaminases and bilirubin occurred in a majority of patients who received concurrent ipilimumab and ZELBORAF.
- P-gp substrates (e.g., digoxin): Coadministration with digoxin, a sensitive P-glycoprotein substrate, increased digoxin systemic exposure by 1.8-fold. Avoid concurrent use of P-gp substrates with narrow therapeutic indices; if unavoidable, consider dose reduction of the P-gp substrate.
Read the label’s full interactions text
7 DRUG INTERACTIONS Avoid concomitant administration of ZELBORAF with strong CYP3A4 inhibitors or inducers. ( 7.1 ) CYP1A2 Substrates: ZELBORAF can increase concentrations of CYP1A2 substrates. Avoid concomitant use of ZELBORAF with CYP1A2 substrates with a narrow therapeutic window. If coadministration cannot be avoided, monitor closely for toxicities and consider dose reduction of CYP1A2 substrates. ( 7.2 ). 7.1 Effect of Strong CYP3A4 Inhibitors or Inducers on Vemurafenib Strong CYP3A4 Inhibitors Coadministration of a strong CYP3A4 inhibitor increased vemurafenib plasma concentrations and may lead to increased toxicity. Avoid coadministration of ZELBORAF with strong CYP3A4 inhibitors. If coadministration of a strong CYP3A4 inhibitor is unavoidable, consider dose reduction of ZELBORAF, if clinically indicated. [see Dosage and Administration (2.3) , Clinical Pharmacology (12.3) ] . Strong CYP3A4 Inducers Coadministration of ZELBORAF with rifampin, a strong CYP3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy. Avoid coadministration of ZELBORAF with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin), and replace these drugs with alternative drugs when possible. If coadministration of a strong CYP3A4 inducer is unavoidable, increase the dose of ZELBORAF by 240 mg (one tablet) as tolerated [see Dosage and Administration (2.4) , Clinical Pharmacology (12.3) ] . 7.2 Effect of Vemurafenib on CYP1A2 Substrates Coadministration of ZELBORAF with tizanidine, a sensitive CYP1A2 substrate, increased tizanidine systemic exposure by 4.7-fold. Avoid concomitant use of ZELBORAF with drugs having a narrow therapeutic window that are predominantly metabolized by CYP1A2 [see Clinical Pharmacology (12.3) ] . If coadministration cannot be avoided, monitor closely for toxicities and consider a dose reduction of concomitant CYP1A2 substrates.
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 Vemurafenib
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- Your tumor must have the BRAF mutation.
- Tell your doctor about heart rhythm problems, long QT syndrome or electrolyte problems.
- Mention liver or kidney disease. Dosing in severe impairment is not established.
- Tell them about prior skin cancer or radiation treatment.
- Use effective contraception during treatment and for 2 weeks after the last dose.
- Do not breastfeed during treatment and for 2 weeks after.
- Safety in children has not been established.
- There were too few people 65 and older in studies to compare responses.
What Vemurafenib does in the body
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Vemurafenib can lengthen the QTc interval, a measure of heart electrical timing on an ECG. This effect rises with drug levels. In a study of 132 patients, average changes were modest, with the largest averaging about 15 ms in the first 6 months.
How your body processes Vemurafenib
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After a dose, vemurafenib peaks in the blood in about 3 hours. A high-fat meal raised the amount absorbed about 5-fold in a single-dose study. The drug builds up over roughly 15 to 22 days of twice-daily dosing.
It is more than 99% bound to blood proteins. Most of it leaves the body in the stool (about 94%), with about 1% in the urine. Its median half-life is about 57 hours.
How to store Vemurafenib
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Store at room temperature 20°C–25°C (68°F–77°F); excursions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Vemurafenib
165 supplements and herbal products have documented interactions with Vemurafenib 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 · 118
- 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.
Vemurafenib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Vemurafenib — the kind of thing our pharmacy team would talk through with you at the counter.
What is vemurafenib for?
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How do I take it?
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What side effects should I expect?
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Why do I need so many check-ups?
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How do I protect my skin?
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Can I take other medicines with it?
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Is Vemurafenib available over the counter?
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When was Vemurafenib 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 Vemurafenib on HelloPharmacist
Vemurafenib forms and strengths (how it comes)
Vemurafenib 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 Vemurafenib inactive ingredients by manufacturer.
Tablet
How this form is used
- Zelboraf is used for unresectable or metastatic melanoma with a BRAF V600E mutation.
- Zelboraf is used for Erdheim-Chester disease with a BRAF V600 mutation.
- Zelboraf tablets are taken by mouth about every 12 hours, with or without a meal.
- Do not crush or chew Zelboraf tablets.
- If you vomit after a Zelboraf dose, do not take an extra dose. Take the next one as scheduled.
- A missed Zelboraf dose can be taken up to 4 hours before the next dose.
Vemurafenib on the U.S. market: products, makers and brands
How Vemurafenib 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 Vemurafenib product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Zelboraf; the rest are generics.
How widely Vemurafenib is used (Medicaid data)
A general measure of how commonly Vemurafenib 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 Vemurafenib 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 Vemurafenib prescribed? Of the 1,601 medications we measure, Vemurafenib ranks #1,571 by Medicaid prescriptions — more than 2% of them.
Utilization by Vemurafenib 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.
vemurafenib 240 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 1147223
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 Vemurafenib, 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 Vemurafenib NDCs with Medicaid activity.
Compare Vemurafenib products
A representative set of FDA-listed product records for Vemurafenib — 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 | ||||
| 240 mg | Oral | Genentech, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Vemurafenib NDCs →
Vemurafenib 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 Vemurafenib — 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 Vemurafenib 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.
Vemurafenib FDA approval history
How Vemurafenib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Vemurafenib 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 Vemurafenib recalls since July 2021.
✅No Vemurafenib 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 1147220 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 1147222In current FDA listingsClinical drug / strength (SCD) 240 MGRxCUI 1147223
Look up RxCUI 1147220 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.
Vemurafenib supply and shortage status
Whether Vemurafenib 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.
Vemurafenib brand names
Vemurafenib is sold under one brand name in the FDA directory — Zelboraf. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Vemurafenib: manufacturers and labelers
One company lists Vemurafenib products with the FDA. By number of product records, the largest are Genentech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Vemurafenib drug class (RxNorm)
Vemurafenib belongs to the Kinase Inhibitor 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 Vemurafenib 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. Genentech, 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 →