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ERIVEDGE vismodegib 150 mg Capsule, 28-count — NDC 50242-0140-01 package photo

ERIVEDGE vismodegib 150 mg Capsule, 28-count

by Genentech, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC
NDC 50242-0140-01
🏷️ FDA NDC (as labeled) 50242-140-01 billing pads the product segment with a zero
This package
Contains28-count Medicaid pays$495.01 / unit · 12 mo Per package$13,860.32 / 28 capsules · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $490.26/unit — full pricing hub ↓
Also comes in: 28 capsules 50242-0140-86
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 50242-140-01
Product NDC 50242-140
11-digit billing NDC 50242014001
NCPDP billing unit EA — each (per item)
RxCUI 1242992, 1242998
UNII 25X868M3DS
Application # NDA203388
SPL Set ID eb368bb6-80e3-4df9-8a85-91df0a2ada6a
Established class (EPC) Hedgehog Pathway Inhibitor
Mechanism of action Smoothened Receptor Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-01-30
Route ORAL
Dosage form CAPSULE
Substance VISMODEGIB
GPI-14 21370070000120
GPI class Erivedge
GCN Seq No 068508
GCN 31307
HICL code 038455
Ingredient (HICL) Vismodegib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3M
Therapeutic class — specific (HIC3) Antineoplastic - Hedgehog Pathway Inhibitor
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ERIVEDGE 150 MG CAPSULE
FDB brand name Erivedge
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50242-140-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50242-0140-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Hedgehog Pathway Inhibitor class.

Pharmacologic class Hedgehog Pathway Inhibitor
Drug family (ATC) Hedgehog pathway inhibitors
How it works Smoothened Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGenentech, Inc.
Application holderGENENTECH INC
FDA applicationNDA203388 (NDA)
Labeler code50242
First marketedJan 2012
Product typeHuman Prescription Drug
Portfolio93 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ERIVEDGE 150 MG CAPSULE Ingredient Vismodegib
📖 What it is MedlinePlus · NLM

Vismodegib is used to treat basal cell carcinoma (a type of skin cancer) in people with cancer that has spread to other parts of the body. Vismodegib is also used to treat basal cell carcinoma that cannot be treated with surgery or radiation or has come back after surgery. Vismodegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Erivedge targets a specific type of skin cancer called basal cell carcinoma when it has spread or can't be removed with surgery. It works by blocking a pathway in cancer cells that...
  • What is Erivedge actually treating — is it a cure for my skin cancer?
  • Good news — food doesn't affect how Erivedge works in your body, so you can take it with or without a meal, whichever is easier for you. Just try to take it around the same time ea...
  • Can I take this capsule with food, or do I have to take it on an empty stomach?
📖 Read our full Vismodegib guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Gray / Pink
ShapeCapsule
ImprintVISMO;150;mg
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $495.01 $13,860.32 / 28 capsules
Medicare drug plans payPart D · Q2 2026 $490.26 $13,727.39 / 28 capsules
Medicare Part B allowsASP · J8999 No ASP payment limit on file for J8999 this quarter.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)50242-140-01
11-digit billing NDC50242-0140-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ8999
DescriptorPRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC, NOS
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Erivedge 150 mgthis 50242-0140-01 Genentech, 28 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
First FDA approval
Jan 2012
📍
2026
Currently FDA-listed
14 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 30, 2012 RLD RS ⏳ ~2.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9278961 — method of use (U-1825)
US 7888364 — drug substance
2012 2014 2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 9278961 ↗ Method of use U-1825 Dec 15, 2028
US 7888364 ↗ Drug substance — Nov 11, 2028
Common questions
Is there a generic version of ERIVEDGE 150 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ERIVEDGE 150 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2028 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 50242-0140-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
30K
Gross reimbursed last 4 qtrs
$14.83M
Avg / prescription
$12,908.21
Avg / unit
$495.01
Latest quarter Q4 2025
306Rx
Fee-for-service vs managed care ⓘ
28% FFS 72% MCO
Fee-for-service · 327 Rx Managed care · 822 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 279 units · 3.6 per 100k residents WA Idaho: 290 units · 14.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 3,487 units · 17.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,412 units · 11.3 per 100k residents IL Indiana: 1,765 units · 25.7 per 100k residents IN Ohio: 606 units · 5.1 per 100k residents OH Pennsylvania: 1,014 units · 7.8 per 100k residents PA New Jersey: 674 units · 7.3 per 100k residents NJ Massachusetts: no data reported MA California: 4,054 units · 10.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 811 units · 13.1 per 100k residents MO Kentucky: 1,314 units · 29.0 per 100k residents KY West Virginia: no data reported WV Virginia: 1,401 units · 16.1 per 100k residents VA Maryland: 526 units · 8.5 per 100k residents MD Connecticut: 540 units · 14.9 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,839 units · 24.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,858 units · 17.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,147 units · 3.8 per 100k residents TX Florida: 2,829 units · 12.5 per 100k residents FL
Units reimbursed · per 100k residents
3.629.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 29.0 /100k
2 Indiana 25.7 /100k
3 Arizona 24.7 /100k
4 New York 17.8 /100k
5 North Carolina 17.1 /100k
6 Virginia 16.1 /100k
7 Connecticut 14.9 /100k
8 Idaho 14.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
28 capsules this page50242-0140-01 1,149 Rx · $14,831,531
28 capsules50242-0140-86 No Medicaid data
Drug total (last 4 qtrs): 1,149 Rx · 29,962 units · $14,831,531 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Erivedge — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Erivedge. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$33.58M
Claims incl. refills
2.5K
Beneficiaries
1.1K
Spend / beneficiary
$29,765.87
Spend / claim
$13,478.89
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Vismodegib — the ingredient across all brands.

Top reported reactions

Muscle Spasms2,065
Alopecia1,401
Ageusia1,011
Fatigue970
Death750
Dysgeusia747
Weight Decreased738

Age at onset

Child3
Adult305
Elderly750

Reporter sex

0 reports
Male · 60%
Female · 40%
Unknown · 0%

Serious outcomes

Hospitalization1,147
Death987
Life-threatening111
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 773 146
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50242-0140-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC 2012-01-30 Active
50242-0140-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC 2013-04-09 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 50242-0140-01?
NDC 50242-0140-01 is a 28-count package — 1 bottle, plastic in 1 carton / 28 capsule in 1 bottle, plastic.
What is the difference between NDC 50242-0140-01 and NDC 50242-0140-86?
Both are ERIVEDGE vismodegib 150 mg Capsule — the drug itself is identical. NDC 50242-0140-01 is the 28-count package, while NDC 50242-0140-86 is the 28 capsules package.
What NDC number is used to bill for this package of ERIVEDGE vismodegib 150 mg Capsule?
Bill NDC 50242-0140-01 — the 11-digit billing format is 50242014001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50242-140-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50242-0140-01, written without dashes as 50242014001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50242-0140-01, the first segment (50242) is the labeler code FDA assigned to Genentech, Inc.; the middle segment (0140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 capsules (50242-0140-86). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Genentech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J8999 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: EMBRYO-FETAL TOXICITY ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] .

Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE [ see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] .

Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman.

ERIVEDGE is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.

Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after ERIVEDGE. ( 2.1 , 5.1 , 8.1 , 8.3 ) Advise males of the potential risk of ERIVEDGE exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential.

( 5.1 , 8.3 )

🎯 Indications and Usage 91 words ▾

1 INDICATIONS AND USAGE ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation. ERIVEDGE ® (vismodegib) is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.

( 1 )

⏱️ Dosage and Administration 192 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 150 mg orally once daily. ( 2 )

2.1Important Safety Information Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE [see Use in Specific Populations (8.1 , 8.3) ] .

2.2Recommended Dosage The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity . Swallow capsules whole. Do not open or crush capsules . If a dose of ERIVEDGE is missed, resume dosing with the next scheduled dose.

2.3Dosage Modifications for Adverse Reactions Withhold ERIVEDGE for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment durations shorter than 8 weeks prior to interruptions have not been studied. Permanently discontinue ERIVEDGE if patients experience severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS) [see Warnings and Precautions (5.2) ] .

Interrupt ERIVEDGE for severe or intolerable musculoskeletal adverse reactions. Permanently discontinue ERIVEDGE for recurrent, severe or intolerable musculoskeletal adverse reactions [see Warnings and Precautions (5.3) ] .

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 150 mg with "150 mg" printed on pink opaque body and "VISMO" printed on grey opaque cap in black ink. 150 mg capsules. ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 24 months after the final dose of ERIVEDGE ( 5.1 ) Advise males not to donate semen during and for 3 months after therapy ( 5.1 , 8.3 ) Severe Cutaneous Adverse Reactions: Permanently discontinue ERIVEDGE in patients with these reactions ( 5.2 ) Musculoskeletal Adverse Reactions: Temporary dose interruption or discontinuation may be required for these reactions ( 5.3 ) Premature fusion of the epiphyses ( 5.4 , 8.4 )

5.1Embryo-Fetal Toxicity Based on its mechanism of action, ERIVEDGE can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, vismodegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures lower than the human exposures at the recommended dose of 150 mg once daily [see Use in Specific Populations (8.1) ] . Females of Reproductive Potential Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose [see Use in Specific Populations (8.1 , 8.3) ]. Males Vismodegib is present in semen.

It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise males to use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during therapy and for 3 months after the final dose of ERIVEDGE. Advise male patients not to donate semen during and for 3 months after the final dose of ERIVEDGE [see Use in Specific Populations (8.3) ].

Blood Donation Advise patients not to donate blood or blood products while receiving ERIVEDGE and for 24 months after the final dose of ERIVEDGE.

5.2Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with ERIVEDGE [see Adverse Reactions (6.2) ]. Permanently discontinue ERIVEDGE in patients with these reactions [see Dosage and Administration (2.3) ].

5.3Musculoskeletal Adverse Reactions Musculoskeletal adverse reactions, which may be accompanied by serum creatine phosphokinase (CPK) elevations, have occurred with ERIVEDGE and other drugs which inhibit the hedgehog (Hh) pathway. In the pooled safety population in clinical trials of ERIVEDGE, musculoskeletal and connective tissue adverse reactions occurred in 78% of patients treated, with 7% (9/138) reported as Grade 3. The most frequent manifestations of musculoskeletal and connective tissue adverse reactions (all grades) reported were muscle spasms (72%) and arthralgias (16%).

In a post-approval clinical trial of 1232 patients, Grade 3 or 4 elevations in serum CPK laboratory values occurred in 2.4% of the 453 patients who had any CPK measurement [see Adverse Reactions (6.1) ] . Obtain baseline serum creatine phosphokinase (CPK) and creatinine levels and as clinically indicated (e.g., if muscle symptoms are reported). Depending on the severity of symptoms, temporary dose interruption or discontinuation may be required for musculoskeletal adverse reactions or serum CPK elevation [see Dosage and Administration (2.3) ] .

5.4Premature Fusion of the Epiphyses Premature fusion of the epiphyses has been reported in pediatric patients exposed to ERIVEDGE. In some cases, fusion progressed after drug discontinuation [see Use in Specific Populations (8.4) ]. ERIVEDGE is not indicated for pediatric patients.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.3) ] Premature Fusion of the Epiphyses [see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence of ≥ 10%) are muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia.

To report SUSPECTED ADVERSE REACTIONS, contact Genentech, Inc. at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described below reflect exposure to ERIVEDGE in 138 patients with advanced basal cell carcinoma (BCC) who received ERIVEDGE at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials [Study SHH3925g, SHH4437g, SHH4476g and SHH4610g].

The median age of these patients was 61 years (range 21 to 101 years), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (range 21 days to 36 months); 111 patients received ERIVEDGE for 6 months or longer. The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia ( Table 1 ).

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients with Advanced Basal Cell Carcinoma Adverse Reaction ERIVEDGE (N = 138) All Grades Grading according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0. (%) Grade 3 (%) Grade 4 (%) Gastrointestinal Nausea 30% 0.7% - Diarrhea 29% 0.7% - Constipation 21% - - Vomiting 14% - - General Fatigue 40% 5% 0.7% Investigations Weight loss 45% 7% - Metabolism and nutrition Decreased appetite 25% 2.2% - Musculoskeletal and connective tissue Muscle spasms 72% 3.6% - Arthralgias 16% 0.7% Nervous system Dysgeusia 55% - - Ageusia 11% - - Skin and subcutaneous tissue Alopecia 64% - - Amenorrhea Among patients from the clinical trials included in the pooled safety data analysis, 30% of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE.

Laboratory Abnormalities Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%) and hypokalemia (1%). Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with ERIVEDGE, a subset of 29 patients had baseline values for blood creatine phosphokinase (CPK) reported. Within this subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK.

Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERIVEDGE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hepatobiliary disorders: Drug-induced liver injury Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [see Warnings and Precautions (5.2) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 ) Females and Males of Reproductive Potential: May cause amenorrhea in females. ( 8.3 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ERIVEDGE during pregnancy. Report pregnancies to Genentech at 1-888-835-2555. Risk Summary Based on its mechanism of action and findings from animal reproduction studies, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .

In animal reproduction studies, oral administration of vismodegib during organogenesis at doses below the 150 mg clinical dose resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats (see Data ) . There are no human data on the use of ERIVEDGE in pregnant women. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal toxicity study, pregnant rats were administered vismodegib orally at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day [approximately 2 times the human exposure at the 150 mg clinical dose based on area under the curve (AUC)], which included early resorption of 100% of the fetuses.

A dose of 10 mg/kg/day [approximately 0.2 times the human exposure (AUC) at the recommended 150 mg clinical dose] resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).

8.2Lactation No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from ERIVEDGE, advise women that breastfeeding is not recommended during therapy with ERIVEDGE and for 24 months after the final dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE. Contraception Based on its mechanism of action and animal data, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Females Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose.

Males Vismodegib is present in semen [see Clinical Pharmacology (12.3) ] . It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients to use condoms, even after a vasectomy, to avoid drug exposure to pregnant partners and female partners of reproductive potential during therapy with and for 3 months after the final dose of ERIVEDGE.

Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to ERIVEDGE. Advise males not to donate semen during therapy with ERIVEDGE and for 3 months after the final dose. Infertility Females Amenorrhea can occur in females of reproductive potential.

Reversibility of amenorrhea is unknown [see Adverse Reactions (6.1) ] .

8.4Pediatric Use The safety and effectiveness of ERIVEDGE have not been established in pediatric patients. Premature fusion of the epiphyses [see Warnings and Precautions (5.3) ] and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases, epiphyseal fusion progressed after drug discontinuation . Juvenile Animal Toxicity Data In repeat-dose toxicology studies in rats, administration of oral vismodegib resu…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ERIVEDGE during pregnancy. Report pregnancies to Genentech at 1-888-835-2555. Risk Summary Based on its mechanism of action and findings from animal reproduction studies, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .

In animal reproduction studies, oral administration of vismodegib during organogenesis at doses below the 150 mg clinical dose resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats (see Data ) . There are no human data on the use of ERIVEDGE in pregnant women. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal toxicity study, pregnant rats were administered vismodegib orally at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day [approximately 2 times the human exposure at the 150 mg clinical dose based on area under the curve (AUC)], which included early resorption of 100% of the fetuses.

A dose of 10 mg/kg/day [approximately 0.2 times the human exposure (AUC) at the recommended 150 mg clinical dose] resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).

🧒 Pediatric Use 163 words ▾

8.4Pediatric Use The safety and effectiveness of ERIVEDGE have not been established in pediatric patients. Premature fusion of the epiphyses [see Warnings and Precautions (5.3) ] and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases, epiphyseal fusion progressed after drug discontinuation .

Juvenile Animal Toxicity Data In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the human exposure (AUC) at the 150 mg clinical dose). Abnormalities in growing incisor teeth (including degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the human exposure (AUC) at the 150 mg clinical dose).

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of ERIVEDGE did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

12.2Pharmacodynamics Cardiac Electrophysiology ERIVEDGE did not prolong the QT interval to any clinically relevant extent following 7 days of 150 mg once-daily dosing (at steady state) .

12.3Pharmacokinetics The pharmacokinetics of vismodegib were studied in healthy subjects and patients. Following daily oral dosing, the pharmacokinetics of vismodegib appear to be nonlinear with steady state achieved within 7 days. Increasing the dose from 150 mg to 540 mg (1 to 3.6 times the recommended dose) does not result in higher steady state plasma concentrations.

Average plasma concentration of vismodegib at steady state (C ss,avg ) is ~23 µM following 150 mg once daily dose. Absorption The single dose absolute bioavailability of vismodegib is 32%. Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg or 540 mg vismodegib.

Effect of Food C max and AUC 0-24hr of vismodegib at steady state are not affected by food. Distribution The volume of distribution of vismodegib ranges from 16.4 to

26.6L. Vismodegib plasma protein binding in patients is > 99%. Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG) and binding to AAG is saturable.

Male patients had an average concentration of vismodegib in semen on day 8 that was 6.5% of the average steady state concentration (C ss ) observed in plasma. Elimination The estimated elimination half-life (t 1/2 ) of vismodegib is 4 days after continuous once-daily dosing and 12 days after a single dose. Metabolism Greater than 98% of the total circulating drug-related components are the parent drug.

Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and pyridine ring cleavage. The two most abundant oxidative metabolites recovered in feces are produced in vitro by recombinant CYP2C9 and CYP3A. Excretion Vismodegib and its metabolites are eliminated primarily by the hepatic route with 82% of the administered dose recovered in the feces and 4.4% recovered in urine.

Specific Populations Weight (41-140 kg), age (26-89 years), sex, mild to moderate renal impairment (creatinine clearance of 30 to 79 mL/min), mild hepatic impairment (normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin > 1 to 1.5 times ULN), moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN), or severe hepatic impairment (total bilirubin > 3 to 10 times ULN) had no clinically relevant effects on the systemic exposure of vismodegib. The impact of severe renal impairment on the pharmacokinetics of vismodegib is unknown.

Drug Interaction Studies Clinical Studies No clinically significant differences in vismodegib pharmacokinetics were observed when used concomitantly with fluconazole (moderate CYP2C9 and CYP3A4 inhibitor), itraconazole (strong CYP3A4 inhibitor and P-gp inhibitor) and rabeprazole (gastric acid reducing agent, proton pump inhibitor). No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with vismodegib: rosiglitazone (a CYP2C8 substrate) or ethinyl estradiol and norethindrone (oral contraceptive).

In Vitro Studies Vismodegib is an inhibitor of the transporter BCRP and is not an inducer of CYP1A2, CYP2B6, or CYP3A.

🧬 Mechanism of Action 26 words ▾

12.1Mechanism of Action Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ERIVEDGE capsules have a pink opaque body and a grey opaque cap with "150 mg" printed on the capsule body and "VISMO" printed on the capsule cap in black ink. ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01). Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep the bottle tightly closed to protect from moisture.

📦 Storage and Handling 33 words ▾

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed to protect from moisture.

📋 Description 149 words ▾

11 DESCRIPTION Vismodegib is a hedgehog (Hh) pathway inhibitor, which is described chemically as 2-Chloro- N -(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide. The molecular formula is C 19 H 14 Cl 2 N 2 O 3 S. The molecular weight is 421.3 g/mol and the structural formula is: Vismodegib is a crystalline free base with a pKa (pyridinium cation) of 3.8, appearing as a white to tan powder.

The solubility of vismodegib is pH dependent with 0.1 µg/mL at pH 7 and 0.99 mg/mL at pH 1. The partition coefficient (log P) is 2.7. ERIVEDGE (vismodegib) for oral administration is supplied in capsules containing 150 mg vismodegib and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine).

The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Embryo-Fetal Toxicity [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] Females of Reproductive Potential Advise women of the potential risk to a fetus. Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy.

Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to ERIVEDGE during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-835-2555. Advise females of reproductive potential to use effective contraception during therapy with ERIVEDGE and for 24 months after the final dose. Males Advise males, even those with prior vasectomy, to use condoms to avoid potential drug exposure in both pregnant partners and female partners of reproductive potential during therapy with ERIVEDGE and for 3 months after the final dose.

Advise males not to donate semen during therapy with ERIVEDGE and for 3 months after the final dose. Blood Donation Advise patients not to donate blood or blood products during therapy with ERIVEDGE and for 24 months after the final dose. Lactation Advise women not to breastfeed during therapy with ERIVEDGE and for 24 months after the final dose [see Use in Specific Populations (8.2) ] .

Severe Cutaneous Reactions Inform patients of the signs and symptoms of severe cutaneous reactions. Advise patients to contact their healthcare provider immediately for signs and symptoms of severe cutaneous reactions [see Warnings and Precautions (5.2) ] . Muscle-related adverse reactions Advise patients starting therapy with ERIVEDGE of the risk of muscle-related adverse reactions.

Advise patients to contact their healthcare provider immediately for any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing ERIVEDGE [see Warnings and Precautions (5.3) ]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: March 2023 MEDICATION GUIDE ERIVEDGE ® (EH-rih-vej) (vismodegib) Capsule What is the most important information I should know about ERIVEDGE?

ERIVEDGE can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. For females who can become pregnant: You should talk with your healthcare provider about the risks of ERIVEDGE to your unborn child. Your healthcare provider will do a pregnancy test within 7 days before you start taking ERIVEDGE.

In order to avoid pregnancy, you should use birth control during treatment and for 24 months after your final dose of ERIVEDGE. Talk with your healthcare provider about what birth control method is right for you during this time. Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.

Tell your healthcare provider right away if you become pregnant or think that you may be pregnant. For males: ERIVEDGE is present in semen. Do not donate semen while you are taking ERIVEDGE and for 3 months after your final dose.

You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with ERIVEDGE and for 3 months after your final dose to protect your female partner from being exposed to ERIVEDGE. Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking ERIVEDGE. Pregnancy Exposure Registry: There is a Pregnancy Exposure Registry for females taking ERIVEDGE who become pregnant.

The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to ERIVEDGE during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with ERIVEDGE, you or your healthcare provider should report your pregnancy to Genentech at 1-888-835-2555.

What is ERIVEDGE? ERIVEDGE is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body, or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation. It is not known if ERIVEDGE is safe and effective in children.

Before taking ERIVEDGE, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. See " What is the most important information I should know about ERIVEDGE? " are breastfeeding or plan to breastfeed. It is not known if ERIVEDGE passes into your breast milk.

You should not breastfeed during treatment and for 24 months after your final dose of ERIVEDGE. Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take ERIVEDGE? Take ERIVEDGE exactly as your healthcare provider tells you. You can take ERIVEDGE with or without food.

Swallow ERIVEDGE capsules whole. Do not open or crush the capsules . Take ERIVEDGE 1 time each day.

If you miss a dose, skip the missed dose. Just take your next scheduled dose. Your healthcare provider will perform certain tests to check you for side effects before and during treatment with ERIVEDGE.

Your healthcare provider may temporarily or permanently stop treatment with ERIVEDGE if you have certain side effects. Do not stop taking ERIVEDGE unless your healthcare provider tells you to. What should I avoid while taking ERIVEDGE?

Do not donate blood or blood products while you are taking ERIVEDGE and for 24 months after your final dose. For Males: Do not donate semen while you are taking ERIVEDGE and for 3 months after your final dose. What are the possible…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50242-0139-04 · Genentech, 50242-0141-04 · Genentech, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.