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Vumerity diroximel fumarate 231 mg Capsule, 106-count — NDC 64406-0020-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vumerity diroximel fumarate 231 mg Capsule, 106-count — NDC 64406-020-01 (Billing 64406-0020-01)

by Biogen Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 106 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 106 capsules of Vumerity diroximel fumarate 231 mg Capsule from Biogen Inc., no longer marketed (first marketed Oct 2019), no longer in the FDA NDC Directory.

NDC 64406-0020-01
🏷️ FDA NDC (as labeled) 64406-020-01 billing pads the product segment with a zero
This package
Contains106-count Pack sizes4 compare ↓
Product page 64406-0020-03 Also comes in: 14 capsules 64406-020-07 106 capsules 64406-020-05 120 capsules 64406-020-03
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64406-020-01
Product NDC 64406-020
11-digit billing NDC 64406002001
NCPDP billing unit EA — each (per item)
RxCUI 2261788, 2261794
UNII K0N0Z40J3W
UPC 0364406020032
Application # NDA211855
SPL Set ID 2d74414f-6b83-4ea2-9a95-3cecabbce774
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2019-10-29
Route ORAL
Dosage form CAPSULE
Substance DIROXIMEL FUMARATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62405530006540
GPI class Vumerity (Starter)
GCN Seq No 080393
GCN 47209
HICL code 046164
Ingredient (HICL) Diroximel Fumarate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0E
Therapeutic class — specific (HIC3) Agents To Treat Multiple Sclerosis
AHFS code 90:04.08.00
AHFS class Fumarates
FDB label name VUMERITY DR 231 MG CAPSULE
FDB brand name Vumerity
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080393
  • GCN: 47209
  • GPI-14 (Medi-Span): 62405530006540
  • HICL (First Databank): 046164
  • AHFS class code: 90:04.08.00
  • RxCUI (RxNorm): 2261788
Why two NDCs? The FDA registers this code as 64406-020-01 — 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 → 64406-0020-01. 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 Other immunosuppressants class.

Drug family (ATC) Other immunosuppressants
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.

Clinical

Label name VUMERITY DR 231 MG CAPSULE Ingredient Diroximel Fumarate
📖 What it is MedlinePlus · NLM

Diroximel fumarate is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Diroximel fumarate is in a class of medications...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Vumerity is for adults with relapsing forms of multiple sclerosis. That includes a first episode of MS-like symptoms, relapsing-remitting MS and active secondary progressive MS.
  • Take the capsules by mouth twice a day, as your prescriber directs. You start lower for the first week, then move to the full dose. Swallow them whole, and don't crush, chew or ope...
  • You can take it with food, but avoid high-fat, high-calorie meals or snacks. Keep alcohol away from it. If flushing bothers you, ask whether taking a non-enteric coated aspirin abo...
  • Flushing and stomach upset are the most common, including stomach pain, diarrhea and nausea. Some people also get itching or a rash. Tell your doctor if these are hard to handle, a...
📖 Read our full Diroximel Fumarate 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.

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 capsules 106 capsules 120 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64406-0020-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 106 CAPSULE in 1 BOTTLE, PLASTIC 2019-10-29 — Discontinued by firm
64406-0020-03 64406-020-03 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 120 CAPSULE in 1 BOTTLE, PLASTIC 2019-10-29 — Active
64406-0020-05 64406-020-05 1 BOTTLE, PLASTIC in 1 CARTON / 106 CAPSULE in 1 BOTTLE, PLASTIC 2019-10-29 — Discontinued by firm
64406-0020-07 64406-020-07 1 BOTTLE, PLASTIC in 1 CARTON / 14 CAPSULE in 1 BOTTLE, PLASTIC Sample 2022-09-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 106-count package — 1 bottle, plastic in 1 carton / 106 capsule in 1 bottle, plastic.
How does this package differ from NDC 64406-0020-07?
Both are Vumerity diroximel fumarate 231 mg Capsule — the drug itself is identical. This page's package is the 106-count one, while NDC 64406-0020-07 is the 14 capsules package.
What NDC number is used to bill for this package of Vumerity diroximel fumarate 231 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vumerity 231 mgthis 64406-0020-01 Biogen 106 capsules — AB Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2019
First FDA approval
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 29, 2019 AB TE-rated RLD RS ⏳ ~7.1 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 9090558 — method of use (U-1384)
US 10080733 — drug substance (U-1384)
US 8669281 — drug substance
2019 2021 2023 2025 2027 2029 2031 2033
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 (3)
PatentTypeUse codeExpires
US 9090558 ↗ Method of use U-1384 Sep 20, 2033
US 10080733 ↗ Drug substance U-1384 Sep 20, 2033
US 8669281 ↗ Drug substance — Oct 29, 2033
Common questions
Is there a generic version of VUMERITY DR 231 MG CAPSULE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for VUMERITY DR 231 MG CAPSULE. See the alternatives section for substitutable, lower-cost products.
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.

What it looks like

Color white
ShapeCapsule
ImprintDRF;231;mg
Size22 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 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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.

Manufacturer & labeler

LabelerBiogen Inc.
Application holderBIOGEN INC
FDA applicationNDA211855 (NDA)
Labeler code64406
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio47 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Blood tests are required prior to initiation of VUMERITY ( 2.1 ) Starting dose: 231 mg twice a day, orally, for 7 days ( 2.2 ) Maintenance dose after 7 days: 462 mg (administered as two 231 mg capsules) twice a day, orally ( 2.2 ) Swallow VUMERITY capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food ( 2.3 ) Avoid administration of VUMERITY with a high-fat, high-calorie meal/snack ( 2.3 ) Avoid co-administration of VUMERITY with alcohol ( 2.3 )

2.1Blood Tests Prior to Initiation of VUMERITY Obtain the following prior to treatment with VUMERITY: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] .

2.2Dosing Information The starting dosage for VUMERITY is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage.

Within 4 weeks, the recommended dosage of 462 mg twice a day should be resumed. Discontinuation of VUMERITY should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to VUMERITY dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )].

2.3Administration Instructions Swallow VUMERITY capsules whole and intact. Do not crush or chew, or sprinkle the capsule contents on food. If taken with food, avoid a high-fat, high-calorie meal/snack; the meal/snack should contain no more than 700 calories and no more than 30 g fat [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 )] . Avoid co-administration of VUMERITY with alcohol [see Clinical Pharmacology ( 12.3 )] .

2.4Blood Tests to Assess Safety After Initiation of VUMERITY Obtain a complete blood cell count (CBC), including lymphocyte count, 6 months after initiation of VUMERITY and then every 6 to 12 months thereafter, as clinically indicated [see Warnings and Precautions ( 5.4 )]. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels during treatment with VUMERITY, as clinically indicated [see Warnings and Precautions ( 5.5 )].

2.5Patients With Renal Impairment No dosing adjustment is recommended in patients with mild renal impairment. VUMERITY is not recommended in patients with moderate or severe renal impairment [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS VUMERITY is available as hard, delayed-release capsules containing 231 mg of diroximel fumarate. The capsules have a white cap and a white body, printed with “DRF 231 mg” in black ink on the body. Delayed-release capsules: 231 mg ( 3 )

⛔ Contraindications 71 words ▾

4 CONTRAINDICATIONS VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )]. Taking dimethyl fumarate [see Drug Interactions ( 7.1 )] .

Known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY ( 4 ) Co-administration with dimethyl fumarate ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema: Discontinue and do not restart VUMERITY if these occur. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold VUMERITY at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding VUMERITY in cases of serious infection until the infection has resolved.

( 5.3 ) Lymphopenia: Obtain a CBC including lymphocyte count before initiating VUMERITY, after 6 months, and every 6 to 12 months thereafter. Consider interruption of VUMERITY if lymphocyte counts <0.5 × 10 9 /L persist for more than six months. ( 5.4 ) Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating VUMERITY and during treatment, as clinically indicated.

Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected. ( 5.6 )

5.1Anaphylaxis and Angioedema VUMERITY can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (which has the same active metabolite as VUMERITY) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue VUMERITY and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

5.2Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate (which has the same active metabolite as VUMERITY). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial.

During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5 × 10 9 /L for 3.5 years) while taking dimethyl fumarate [see Warnings and Precautions ( 5.4 )]. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.

PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9 × 10 9 /L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8×10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold VUMERITY and perform an appropriate diagnostic evaluation.

Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Cases of PML diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with PML.

Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.1 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions Section ( 5.2 )] Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions ( 5.3 )] Lymphopenia [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.6 )] Flushing [see Warnings and Precautions ( 5.6 )] Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence for dimethyl fumarate [which has the same active metabolite as VUMERITY] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 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 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 data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY. In placebo controlled and uncontrolled clinical studies of dimethyl fumarate (which has the same active metabolite as VUMERITY), a total of 2513 patients have been followed for periods up to 13 years with an overall exposure equivalent to 11,318 person-years.

A total of 1169 patients have received at least 5 years of treatment with dimethyl fumarate, and 426 patients have received at least 10 years of treatment with dimethyl fumarate. Adverse Reactions in Placebo-Controlled Trials with Dimethyl Fumarate In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies ( 14 )]. The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients.

The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea. Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥2% Higher Incidence than Placebo Adverse Reactions Dimethyl Fumarate 240 mg Twice Daily (N=769) % Placebo (N=771) % Flushing 40 6 Abdominal pain 18 10 Diarrhea 14 11 Nausea 12 9 Vomiting 9 5 Pruritus 8 4 Rash 8 3 Albumin urine present 6 4 Erythema 5 1 Dyspepsia 5 3 Aspartate aminotransferase increased 4 2 Lymphopenia 2 <1 Gastrointestinal Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia).

The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in clinical trial patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%).

Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and placebo and were balanced between groups. There were no elevations in transaminases ≥3 time… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 40 words ▾

7 DRUG INTERACTIONS

7.1Concomitant Dimethyl Fumarate VUMERITY is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. VUMERITY may be initiated the day following discontinuation of dimethyl fumarate [see Contraindications ( 4 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) VUMERITY is not recommended in patients with moderate or severe renal impairment. ( 8.6 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VUMERITY during pregnancy. Encourage patients to enroll by calling 1-833-569-2635 or visiting www.vumeritypregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of VUMERITY in pregnant women.

Available data from a pregnancy registry for dimethyl fumarate (which has the same active metabolite as VUMERITY), observational studies, and pharmacovigilance pertaining to dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data ). In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposures [ see Data ].

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Human Data In a prospective observational pregnancy registry for dimethyl fumarate (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI: 1.9-6.1). No specific pattern of major birth defects was identified. Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.

Animal Data Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) to pregnant rats throughout organogenesis resulted in a decrease in fetal body weight and an increase in fetal skeletal variations at the highest dose tested, which was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES (the major circulating drug-related compound in humans) at the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal development were approximately 2 times those in humans at the recommended human dose (RHD) of 924 mg/day.

Oral administration of diroximel fumarate (0, 50, 150, or 350 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in an increase in fetal skeletal malformations at the mid and high doses and reduced fetal body weight and increases in embryofetal death and fetal skeletal variations at the highest dose tested. The high dose was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES at the no-effect dose (50 mg/kg/day) for adverse effects on embryofetal development were similar to (MMF) or less than (HES) those in humans at the RHD.

Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) to rats throughout gestation and lactation resulted in reduced weight, which persisted into adulthood, and adverse effects on neurobehavioral function in offspring at the highest dose tested. Plasma exposures (AUC) for MMF and HES at the no-effect dose for adverse effects on postnatal development (100 mg/kg/day) were approximately 3 times (MMF) or similar to (HES) those in humans at the RHD.

8.2Lactation Risk Summary There are no data on the presence of diroximel fumarate or metabolites (MMF, HES) in human milk. The effects on the breastfed infant and on milk production are unknown. The… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VUMERITY during pregnancy. Encourage patients to enroll by calling 1-833-569-2635 or visiting www.vumeritypregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of VUMERITY in pregnant women.

Available data from a pregnancy registry for dimethyl fumarate (which has the same active metabolite as VUMERITY), observational studies, and pharmacovigilance pertaining to dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data ). In animal studies, administration of diroximel fumarate during pregnancy or throughout pregnancy and lactation resulted in adverse effects on embryofetal and offspring development (increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment) at clinically relevant drug exposures [ see Data ].

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Human Data In a prospective observational pregnancy registry for dimethyl fumarate (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI: 1.9-6.1). No specific pattern of major birth defects was identified. Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.

Animal Data Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) to pregnant rats throughout organogenesis resulted in a decrease in fetal body weight and an increase in fetal skeletal variations at the highest dose tested, which was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES (the major circulating drug-related compound in humans) at the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal development were approximately 2 times those in humans at the recommended human dose (RHD) of 924 mg/day.

Oral administration of diroximel fumarate (0, 50, 150, or 350 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in an increase in fetal skeletal malformations at the mid and high doses and reduced fetal body weight and increases in embryofetal death and fetal skeletal variations at the highest dose tested. The high dose was associated with maternal toxicity. Plasma exposures (AUC) for MMF and HES at the no-effect dose (50 mg/kg/day) for adverse effects on embryofetal development were similar to (MMF) or less than (HES) those in humans at the RHD.

Oral administration of diroximel fumarate (0, 40, 100, or 400 mg/kg/day) to rats throughout gestation and lactation resulted in reduced weight, which persisted into adulthood, and adverse effects on neurobehavioral function in offspring at the highest dose tested. Plasma exposures (AUC) for MMF and HES at the no-effect dose for adverse effects on postnatal development (100 mg/kg/day) were approximately 3 times (MMF) or similar to (HES) those in humans at the RHD.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 31 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.

MMF has been identified as a nicotinic acid receptor agonist in vitro .

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 2 times the maximum recommended dose, VUMERITY does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics After oral administration of VUMERITY, diroximel fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF). Diroximel fumarate is not quantifiable in plasma following oral administration of VUMERITY. Therefore, all pharmacokinetic analyses related to VUMERITY were performed with plasma MMF concentrations.

Pharmacokinetic data were obtained in subjects with relapsing forms of multiple sclerosis (MS) and healthy volunteers. Absorption Following oral administration of VUMERITY, the median t max of MMF is 2.5 to 3 hours. The peak plasma concentration (C max ) and overall exposure (AUC) increased dose proportionally in the recommended daily dose range (462 mg to 924 mg).

Following administration of VUMERITY 462 mg in patients with MS, the mean C max of MMF was 2.11 mg/L. The mean steady state AUC of MMF was estimated to be 8.32 mg.hr/L following twice daily dosing in patients with MS. Effect of Food In an open-label, randomized, balanced, crossover study, co-administration of VUMERITY with a high-fat, high-calorie meal (900-1000 calories, 50% of calories from fat) did not affect the AUC of MMF, but resulted in an approximately 44% reduction in C max compared to fasted state [see Dosage and Administration ( 2.3 )] .

The MMF C max with low-fat, low-calorie (350 to 400 calories, 10 to 15 g fat) and medium-fat, medium-calorie (650 to 700 calories, 25 to 30 g fat) meals was reduced by approximately 12% and 25%, respectively. Relative to fasted state, the t max of MMF was delayed from 2.5 hours (fasted state) to 4.5 hours (low-fat, low-calorie meal or a medium-fat, medium-calorie meal) and 7.0 hours (high-fat, high-calorie meal) in the fed state. There was no impact of low, medium, or high-fat meals on the AUC of MMF after administration of VUMERITY.

Distribution The apparent volume of distribution for MMF is between 72 L and 83 L in healthy subjects after administration of VUMERITY. Human plasma protein binding of MMF is 27-45% and independent of concentration. Elimination Metabolism In humans, diroximel fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, to the major active metabolite, MMF, before it reaches the systemic circulation.

Further metabolism of MMF occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP) system. Fumaric and citric acid, and glucose are the major metabolites of MMF in plasma. Esterase metabolism of diroximel fumarate also produces 2-hydroxyethyl succinimide (HES), an inactive major metabolite.

Excretion MMF is mainly eliminated as carbon dioxide in the expired air with only trace amounts (less than 0.3% of the total dose) recovered in urine. The terminal half-life of MMF is approximately 1 hour, and accumulation of MMF does not occur with multiple doses of VUMERITY. HES is mainly eliminated in urine (58-63% of the dose was excreted as HES in urine).

Specific Populations Age (18-79 years), sex, and race (White, African American, and Asian) did not have clinically meaningful effects on the pharmacokinetics of MMF after administration of VUMERITY. The effect of hepatic impairment or severe renal impairment (CrCl <30 mL/min, Cockcroft-Gault) requiring hemodialys… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.

MMF has been identified as a nicotinic acid receptor agonist in vitro .

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/ STORAGE AND HANDLING

16.1How Supplied VUMERITY is available as delayed-release capsules for oral administration, containing 231 mg of diroximel fumarate. The 231 mg capsules have a white cap and a white body, printed with “DRF 231 mg” in black ink on the body. VUMERITY is available as follows: Bottle of 120 capsules, NDC 64406-020-03.

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

📦 Storage and Handling 21 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

📋 Description 126 words ▾

11 DESCRIPTION VUMERITY contains diroximel fumarate. The chemical name of diroximel fumarate is 2-Butenedioic acid (2E)-, 1-[2-(2,5-dioxo-1-pyrrolidinyl)ethyl] 4-methyl ester, which has a molecular formula of C 11 H 13 NO 6 and molecular weight of 255.22. Diroximel fumarate has the following structure: Diroximel fumarate is a white to off-white powder that is slightly soluble in water.

VUMERITY is provided as delayed-release capsules for oral administration. Each capsule contains 231 mg of diroximel fumarate and the following inactive ingredients: crospovidone, colloidal silicon dioxide, magnesium stearate (non-bovine), methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, talc, and triethyl citrate. The capsule shell contains carrageenan, hypromellose, potassium chloride, and titanium dioxide.

It is printed with black ink that contains iron oxide, potassium hydroxide, propylene glycol, and shellac. Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Dosage and Administration Inform patients that they will take one capsule twice a day for the first 7 days and then two capsules twice a day thereafter. Advise patients to take VUMERITY as instructed.

Inform patients to swallow VUMERITY capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that they should avoid a high-fat, high-calorie meal/snack at the time they take VUMERITY.

If taken with food, the meal/snack should contain no more than 700 calories and no more than 30 g fat. Advise patients to avoid co-administration of VUMERITY with alcohol [see Dosage and Administration ( 2.2 )]. Anaphylaxis and Angioedema Advise patients to discontinue VUMERITY and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions ( 5.1 )].

Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occured in patients who received dimethyl fumarate, and therefore may occur with VUMERITY. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Inform the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML.

Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions ( 5.2 )] . Herpes Zoster and Other Serious Opportunistic Infections Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received dimethyl fumarate and therefore may occur with VUMERITY.

Instruct the patient of the importance of contacting their doctor if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions ( 5.3 )]. Lymphocyte Counts Inform patients that VUMERITY may decrease lymphocyte counts. A blood test should be obtained before they start therapy.

Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.1 )] . Liver Injury Inform patients that VUMERITY may cause liver injury. Instruct patients treated with VUMERITY to report promptly to their healthcare provider any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions ( 5.5 )] . Flushing Inform patients that flushing is one of the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing.

Advise patients experiencing flushing that taking VUMERITY with food (avoid high-fat, high-calorie meal or snack) or taking a non-enteric coated aspirin prior to taking VUMERITY may help [see Dosage and Administration ( 2.2 ) and Adverse Reactions ( 6.1 )] . Gastrointestinal (GI) Reactions Inform patients that GI events (abdominal pain, diarrhea, and nausea) are some of the most common adverse reactions, especially at the initiation of therapy, and may decrease over time. Some patients may experience more severe GI events, Advise patients to immediately contact their healthcare provider and discontinue VUMERITY if they experience gastrointestinal bleeding (e.g., rectal bleeding, bloody diarrhea, hematemesis) or other serious gastroi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics After oral administration of VUMERITY, diroximel fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its active metabolite, monomethyl fumarate (MMF). Diroximel fumarate is not quantifiable in plasma following oral administration of VUMERITY. Therefore, all pharmacokinetic analyses related to VUMERITY were performed with plasma MMF concentrations.

Pharmacokinetic data were obtained in subjects with relapsing forms of multiple sclerosis (MS) and healthy volunteers. Absorption Following oral administration of VUMERITY, the median t max of MMF is 2.5 to 3 hours. The peak plasma concentration (C max ) and overall exposure (AUC) increased dose proportionally in the recommended daily dose range (462 mg to 924 mg).

Following administration of VUMERITY 462 mg in patients with MS, the mean C max of MMF was 2.11 mg/L. The mean steady state AUC of MMF was estimated to be 8.32 mg.hr/L following twice daily dosing in patients with MS. Effect of Food In an open-label, randomized, balanced, crossover study, co-administration of VUMERITY with a high-fat, high-calorie meal (900-1000 calories, 50% of calories from fat) did not affect the AUC of MMF, but resulted in an approximately 44% reduction in C max compared to fasted state [see Dosage and Administration ( 2.3 )] .

The MMF C max with low-fat, low-calorie (350 to 400 calories, 10 to 15 g fat) and medium-fat, medium-calorie (650 to 700 calories, 25 to 30 g fat) meals was reduced by approximately 12% and 25%, respectively. Relative to fasted state, the t max of MMF was delayed from 2.5 hours (fasted state) to 4.5 hours (low-fat, low-calorie meal or a medium-fat, medium-calorie meal) and 7.0 hours (high-fat, high-calorie meal) in the fed state. There was no impact of low, medium, or high-fat meals on the AUC of MMF after administration of VUMERITY.

Distribution The apparent volume of distribution for MMF is between 72 L and 83 L in healthy subjects after administration of VUMERITY. Human plasma protein binding of MMF is 27-45% and independent of concentration. Elimination Metabolism In humans, diroximel fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, to the major active metabolite, MMF, before it reaches the systemic circulation.

Further metabolism of MMF occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP) system. Fumaric and citric acid, and glucose are the major metabolites of MMF in plasma. Esterase metabolism of diroximel fumarate also produces 2-hydroxyethyl succinimide (HES), an inactive major metabolite.

Excretion MMF is mainly eliminated as carbon dioxide in the expired air with only trace amounts (less than 0.3% of the total dose) recovered in urine. The terminal half-life of MMF is approximately 1 hour, and accumulation of MMF does not occur with multiple doses of VUMERITY. HES is mainly eliminated in urine (58-63% of the dose was excreted as HES in urine).

Specific Populations Age (18-79 years), sex, and race (White, African American, and Asian) did not have clinically meaningful effects on the pharmacokinetics of MMF after administration of VUMERITY. The effect of hepatic impairment or severe renal impairment (CrCl <30 mL/min, Cockcroft-Gault) requiring hemodialysis on MMF pharmacokinetics is unknown. Patients with Renal Impairment A single-dose clinical study investigating the effect of renal impairment on the pharmacokinetics of diroximel fumarate and its metabolites MMF and HES was conducted.

The study included cohorts with mild, moderate, and severe renal impairment and a healthy cohort (8 subjects per cohort) and found no clinically relevant changes in MMF exposure. However, HES exposure increased by 1.3, 1.8, and 2.7-fold with mild, moderate, and severe renal impairment, respectively, compared to the healthy cohort [see Use in Specific Populations ( 8.6 )] . There are no data available on long-term use of… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 25 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 2 times the maximum recommended dose, VUMERITY does not prolong the QTc interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of VUMERITY is based upon bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy subjects comparing oral dimethyl fumarate delayed-release capsules to VUMERITY delayed-release capsules [see Clinical Pharmacology ( 12.3 )]. The clinical studies described below were conducted using dimethyl fumarate. The efficacy and safety of dimethyl fumarate were demonstrated in two studies (Studies 1 and 2) that evaluated dimethyl fumarate taken either twice or three times a day in patients with relapsing-remitting multiple sclerosis (RRMS).

The starting dose for dimethyl fumarate was 120 mg twice or three times a day for the first 7 days, followed by an increase to 240 mg twice or three times a day. Both studies included patients who had experienced at least 1 relapse over the year preceding the trial or had a brain Magnetic Resonance Imaging (MRI) scan demonstrating at least one gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization. The Expanded Disability Status Scale (EDSS) was also assessed and patients could have scores ranging from 0 to 5.

Neurological evaluations were performed at baseline, every 3 months, and at the time of suspected relapse. MRI evaluations were performed at baseline, month 6, and year 1 and 2 in a subset of patients (44% in Study 1 and 48% in Study 2). Study 1: Placebo-Controlled Trial in RRMS Study 1 was a 2-year randomized, double-blind, placebo-controlled study in 1234 patients with RRMS.

The primary endpoint was the proportion of patients relapsed at 2 years. Additional endpoints at 2 years included the number of new or newly enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of Gd+ lesions, annualized relapse rate (ARR), and time to confirmed disability progression. Confirmed disability progression was defined as at least a 1 point increase from baseline EDSS (1.5 point increase for patients with baseline EDSS of 0) sustained for 12 weeks.

Patients were randomized to receive dimethyl fumarate 240 mg twice a day (n=410), dimethyl fumarate 240 mg three times a day (n=416), or placebo (n=408) for up to 2 years. The median age was 39 years, median time since diagnosis was 4 years, and median EDSS score at baseline was 2. The median time on study drug for all treatment arms was 96 weeks.

The percentages of patients who completed 96 weeks on study drug per treatment group were 69% for patients assigned to dimethyl fumarate 240 mg twice a day, 69% for patients assigned to dimethyl fumarate 240 mg three times a day, and 65% for patients assigned to placebo groups. Dimethyl fumarate had a statistically significant effect on all of the endpoints described above and the 240 mg three times daily dose showed no additional benefit over the dimethyl fumarate 240 mg twice daily dose. The results for this study (240 mg twice a day vs. placebo) are shown in Table 2 and Figure 1 .

Table 2: Clinical and MRI Results of Study 1 Dimethyl Fumarate 240 mg BID Placebo P-value Clinical Endpoints N=410 N=408 Proportion relapsing (primary endpoint) 27% 46% <0.0001 Relative risk reduction 49% Annualized relapse rate 0.172 0.364 <0.0001 Relative reduction 53% Proportion with disability progression 16% 27% 0.0050 Relative risk reduction 38% MRI Endpoints N=152 N=165 Mean number of new or newly enlarging T2 lesions over 2 years 2.6 17 <0.0001 Percentage of subjects with no new or newly enlarging lesions 45% 27% Number of Gd+ lesions at 2 years Mean (median) 0.1 (0) 1.8 (0) Percentage of subjects with 0 lesions 93% 62% 1 lesion 5% 10% 2 lesions <1% 8% 3 to 4 lesions 0 9% 5 or more lesions <1% 11% Relative odds reduction (percentage) 90% <0.0001 Mean number of new T1 hypointense lesions over 2 years 1.5 5.6 <0.0001 Figure 1: Time to 12-Week Confirmed Progression of Disability (Study 1) Figure 1 Study 2: Placebo-Controlled Trial in RRMS Study 2 was a 2-year multicenter, randomized, double-blind, placebo-controlled study that also includ… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of diroximel fumarate (0, 0, 30, 100, 300 or 1000 [females only] mg/kg/day) for 26 weeks to Tg.rasH2 mice resulted in no drug-related tumors. Oral administration of diroximel fumarate (0, 0, 15, 50, or 150 mg/kg/day) to male and female rats resulted in an increase in tumors (Leydig cell adenomas of the testes) in males at the highest dose tested. At the higher dose (50 mg/kg/day) not associated with drug-related tumors, plasma exposures for MMF and HES (the major circulating drug-related compound in humans) were similar to (MMF) and less than (HES) those in humans at the recommended human dose (RHD) of 924 mg/day.

Mutagenesis Diroximel fumarate was negative in the in vitro bacterial reverse mutation and in vivo rat micronucleus and comet assays. Diroximel fumarate was clastogenic (in the absence and presence of metabolic activation) in the in vitro chromosomal aberration assay in human peripheral blood lymphocytes. Impairment of Fertility No adverse effects on fertility were observed following oral administration of diroximel fumarate to male rats (0, 40, 120, or 400 mg/kg/day) prior to and during mating with untreated females and, in a separate study, to female rats (0, 40, 120, or 450 mg/kg/day) prior to and during mating with untreated males and continuing to Gestation Day (GD) 7.

At the highest doses tested, plasma exposures (AUC) for MMF were approximately 7-9 times that in humans at the RHD. Plasma levels of HES were not quantitated.

13.2Animal Toxicology and/or Pharmacology Kidney toxicity, including tubular changes (degeneration, necrosis, regeneration, hypertrophy) and/or interstitial fibrosis, were observed following oral administration of diroximel fumarate in rats and monkeys. In the chronic toxicology study in rats (0, 50, 100, or 300 mg/kg/day), adverse renal findings occurred at all doses tested. Plasma exposures (AUC) at the low dose (50 mg/kg/day) were similar to (MMF) or less than (HES) those in humans at the RHD.

In the chronic toxicology study in monkeys (0, 15, 50, or 150 mg/kg/day), adverse renal findings occurred at all but the lowest dose tested (15 mg/kg/day), which was associated with plasma MMF and HES exposures (AUC) less than those in humans at the RHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of diroximel fumarate (0, 0, 30, 100, 300 or 1000 [females only] mg/kg/day) for 26 weeks to Tg.rasH2 mice resulted in no drug-related tumors. Oral administration of diroximel fumarate (0, 0, 15, 50, or 150 mg/kg/day) to male and female rats resulted in an increase in tumors (Leydig cell adenomas of the testes) in males at the highest dose tested. At the higher dose (50 mg/kg/day) not associated with drug-related tumors, plasma exposures for MMF and HES (the major circulating drug-related compound in humans) were similar to (MMF) and less than (HES) those in humans at the recommended human dose (RHD) of 924 mg/day.

Mutagenesis Diroximel fumarate was negative in the in vitro bacterial reverse mutation and in vivo rat micronucleus and comet assays. Diroximel fumarate was clastogenic (in the absence and presence of metabolic activation) in the in vitro chromosomal aberration assay in human peripheral blood lymphocytes. Impairment of Fertility No adverse effects on fertility were observed following oral administration of diroximel fumarate to male rats (0, 40, 120, or 400 mg/kg/day) prior to and during mating with untreated females and, in a separate study, to female rats (0, 40, 120, or 450 mg/kg/day) prior to and during mating with untreated males and continuing to Gestation Day (GD) 7.

At the highest doses tested, plasma exposures (AUC) for MMF were approximately 7-9 times that in humans at the RHD. Plasma levels of HES were not quantitated.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2024 PPI-54499-03 Patient Information VUMERITY (vue mer' i tee) (diroximel fumarate) delayed-release capsules What is VUMERITY?

VUMERITY is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is not known if VUMERITY is safe and effective in children. Do not take VUMERITY if you: have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to diroximel fumarate, dimethyl fumarate, or any of the ingredients in VUMERITY.

See “ What are the ingredients in VUMERITY? ” below for a complete list of ingredients. are taking dimethyl fumarate. Before taking and while you take VUMERITY, tell your doctor about all of your medical conditions, including if you: have liver problems. have kidney problems. have or have had low white blood cell counts or an infection. are pregnant or plan to become pregnant. It is not known if VUMERITY will harm your unborn baby.

If you become pregnant while taking VUMERITY, talk to your healthcare provider about enrolling in the VUMERITY Pregnancy Registry. You can enroll in this registry by calling 1-833-569-2635 or visiting www.vumeritypregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby. are breastfeeding or plan to breastfeed.

It is not known if VUMERITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VUMERITY. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VUMERITY? Take VUMERITY exactly as your doctor tells you to take it. The recommended starting dose on days 1 to 7 is one capsule by mouth 2 times a day.

After 7 days, the recommended dose is 2 capsules by mouth 2 times a day. If taken with food, avoid taking VUMERITY with a high-fat, high-calorie meal or snack. Your meal or snack should contain no more than 700 calories and no more than 30 g of fat.

Swallow VUMERITY whole. Do not crush, chew, or sprinkle capsule contents on food. If you take too much VUMERITY, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking VUMERITY? Do not drink alcohol at the time you take a VUMERITY dose. What are the possible side effects of VUMERITY?

VUMERITY may cause serious side effects including: allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking VUMERITY and get emergency medical help right away if you get any of these symptoms. PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months.

Tell your doctor right away if you get any of these symptoms of PML: weakness on one side of the body that gets worse vision problems confusion clumsiness in your arms or legs changes in thinking and memory personality changes herpes zoster infections (shingles), including central nervous system infections. other serious infections decreases in your white blood cell count. Your doctor should do a blood test to check your white blood cell count before you start treatment with VUMERITY and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that. liver problems.

Your doctor should do blood tests to check your liver function before you start taking VUMERITY and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment. severe tiredness loss of appetite pain on the right side of your stomach have dark or brown (tea color) urine yellowing of your skin or the white… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 10 words ▾

Warnings and Precautions, Serious Gastrointestinal Reactions ( 5.7 ) 12/2023

📄 Package Label / Principal Display Panel 95 words ▾

Principal Display Panel – 120 Capsule Carton Label 120 Capsules RX Only NDC 64406-020-03 VUMERITY™ (diroximel fumarate) delayed-release capsules 231 mg Swallow capsule whole. Manufactured for: Biogen Inc. Cambridge, MA 02142 Product of the United Kingdom. Biogen ® Principal Display Panel – 120 Capsule Carton Label

Principal Display Panel – 120 Capsule Bottle Label 120 Capsules RX Only NDC 64406-020-03 VUMERITY™ (diroximel fumarate) delayed-release capsules 231 mg Swallow capsule whole. Each capsule contains 231 mg of diroximel fumarate. Information and support: 1-800-456-2255 VUMERITY.com Biogen ® 120 Capsules Principal Display Panel – 120 Capsule Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
120 capsules64406-0020-03 6,829 Rx · $66,556,141
106 capsules this page64406-0020-01 No Medicaid data
106 capsules64406-0020-05 No Medicaid data
14 capsules64406-0020-07 No Medicaid data
Drug total (last 4 qtrs): 6,829 Rx · 889,462 units · $66,556,141 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 Vumerity — 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 Vumerity. 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
$77.67M
Claims incl. refills
7.4K
Beneficiaries
3.4K
Spend / beneficiary
$23,143.88
Spend / claim
$10,483.31
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 14 capsules (64406-0020-07), 106 capsules (64406-0020-05), 120 capsules (64406-0020-03). 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?
Biogen 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.
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.
← 64406-0019-01 · BIOGEN 64406-0022-01 · Biogen →
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.