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dimethyl fumarate 240 mg Capsule, Delayed Release, 60-count

by Zydus Pharmaceuticals USA Inc. · 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-6)

NDC 70710-1205-06

🏷️ FDA NDC (as labeled) 70710-1205-6 billing pads the package segment with a zero

This package

Contains60-count Pack sizes2 compare ↓

Also priced by: Part D plans $1.89/unit — full pricing hub ↓

Also comes in: 46 capsules 70710-1205-08

Rx only Generic 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 70710-1205-6

Product NDC 70710-1205

11-digit billing NDC 70710120506

RxCUI 1373483, 1373491, 1373497

UNII FO2303MNI2

Application # ANDA210538

SPL Set ID e7ef9b9e-d97a-4a56-b792-a1a255613156

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-09-28

Route ORAL

Dosage form CAPSULE, DELAYED RELEASE

Substance DIMETHYL FUMARATE

Why two NDCs? The FDA registers this code as 70710-1205-6 — a 5-4-1 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 package segment → 70710-1205-06. 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.

🏭 Manufacturer & labeler

LabelerZydus Pharmaceuticals USA Inc.

Application holderZYDUS PHARMACEUTICALS USA INC

FDA applicationANDA210538 (ANDA)

Labeler code70710

First marketedSep 2020

Product typeHuman Prescription Drug

Portfolio451 products on file

🔎 All NDCs from Zydus Pharmaceuticals USA Inc.

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

📖 What it is MedlinePlus · NLM

Dimethyl fumarate is used to treat adults with relapsing 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). Dimethyl fumarate is in a class of medications called...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Dimethyl fumarate (brand name Tecfidera, also available as a generic) is a prescription medicine for adults with relapsing forms of multiple sclerosis — meaning MS that comes and g...
What exactly is dimethyl fumarate used for?
The two most common things people notice early on are flushing — a sensation of warmth, redness, or tingling, usually in the face and chest — and stomach upset like belly pain, nau...
What side effects should I expect, especially when I first start?

📖 Read our full Dimethyl Fumarate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Dimethyl Fumarate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Dimethyl Fumarate (17 interactions) — ranked by severity →

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 Green / White

ShapeCapsule

Imprint1205

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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue 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 U72Q2I8C85
A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
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 74G4R6TH13
A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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 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 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.

24 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 system	Per each	Per 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 · Q2 2026	$1.89	$113.10 / 60 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dimethyl Fumarate 240 mg 33342-0350-09	Macleods	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 43547-0025-06	Solco	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 43598-0430-60	Dr.	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 59651-0084-60	Aurobindo	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 69097-0323-03	Cipla	60 capsules	$0.450	—	Availability likely	—
Dimethyl Fumarate 240 mg 69238-1319-06	Amneal	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 70512-0853-60	SOLA	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 82009-0138-60	Quallent	60 capsules	$0.450	AB	Availability likely	—
Dimethyl fumarate 240 mg 82249-0747-60	CivicaScript	60 capsules	$0.450	AB	Availability likely	—
Dimethyl Fumarate 240 mg 16729-0417-12	Accord	60 capsules	$0.456	AB	Availability likely	—
dimethyl fumarate 240 mg 24979-0128-02	Upsher-Smith	500 capsules	—	AB	FDA listed	—
Dimethyl Fumarate 240 mg 31722-0658-31	Camber	46 capsules	—	AB	FDA listed	—
Dimethyl Fumarate 240 mg 50090-5288-00	A-S	1 capsule	—	AB	FDA listed	—
dimethyl fumarate 240 mg 51407-0441-60	Golden	60 capsules	—	AB	FDA listed	—
Tecfidera 240 mg 64406-0006-02	Biogen	60 capsules	—	AB	FDA listed	—
Dimethyl fumarate 240 mg 67877-0556-10	Ascend	1000 capsules	—	AB	FDA listed	—
Dimethyl Fumarate 240 mg 68462-0308-05	Glenmark	500 capsules	—	AB	FDA listed	—
Dimethyl Fumarate 240 mg 69539-0043-05	MSN	500 capsules	—	AB	FDA listed	—
dimethyl fumarate 240 mgthis 70710-1205-06	Zydus	60 capsules	—	—	FDA listed	—
dimethyl fumarate 240 mg 70771-1531-06	Zydus	60 capsules	—	—	FDA listed	—
Dimethyl Fumarate 240 mg 84677-0030-60	Golden	60 capsules	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2020

On the market since

Sep 2020

📍

2026

Currently FDA-listed

6 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Dimethyl Fumarate — the program that covers self-administered drugs. 12 manufacturers.

⚠️ 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 Dimethyl Fumarate. 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

$10.94M

Claims incl. refills

14.9K

Beneficiaries

6.3K

Spend / beneficiary

$1,737.88

Spend / claim

$733.91

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 Dimethyl fumarate — the ingredient across all brands.

Top reported reactions

Flushing17,099

Nausea8,969

Diarrhoea8,293

Multiple Sclerosis Relapse8,120

Fatigue6,958

Multiple Sclerosis5,742

Vomiting5,650

Age at onset

Neonate42

Infant7

Child29

Adolescent10

Adult9,246

Elderly363

Reporter sex

Male · 21%

Female · 78%

Unknown · 0%

Serious outcomes

Hospitalization22,867

Death2,169

Disabling501

Life-threatening473

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
70710-1205-06 You're viewing this	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-6)	2020-09-28	Active
70710-1205-08	46 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70710-1205-8)	2020-09-28	Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 70710-1205-06?

NDC 70710-1205-06 is a 60-count package — 60 capsule, delayed release in 1 bottle.

What is the difference between NDC 70710-1205-06 and NDC 70710-1205-08?

Both are dimethyl fumarate 240 mg Capsule, Delayed Release — the drug itself is identical. NDC 70710-1205-06 is the 60-count package, while NDC 70710-1205-08 is the 46 capsules package.

What NDC number is used to bill for this package of dimethyl fumarate 240 mg Capsule, Delayed Release?

Bill NDC 70710-1205-06 — the 11-digit billing format is 70710120506. 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.

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 70710-1205-6, 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: 70710-1205-06, written without dashes as 70710120506. 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 70710-1205-06, the first segment (70710) is the labeler code FDA assigned to Zydus Pharmaceuticals USA Inc.; the middle segment (1205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 Zydus Pharmaceuticals USA 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 46 capsules (70710-1205-08). 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?

Zydus Pharmaceuticals USA 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.

📄 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.

🎯 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 63 words ▾

1 INDICATIONS AND USAGE Dimethyl fumarate 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. Dimethyl fumarate 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 ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dose: 120 mg twice a day, orally, for 7 days ( 2.1 ) Maintenance dose after 7 days: 240 mg twice a day, orally ( 2.1 ) Swallow dimethyl fumarate delayed-release capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food ( 2.1 ) Take dimethyl fumarate delayed-release capsules with or without food ( 2.1 )

2.1Dosing Information The starting dose for dimethyl fumarate delayed-release capsules is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose.

Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of dimethyl fumarate delayed-release capsules should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of dimethyl fumarate delayed-release capsules with food.

Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsules dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )] . Dimethyl fumarate delayed-release capsules should be swallowed whole and intact. Dimethyl fumarate delayed-release capsules should not be crushed or chewed and the capsule contents should not be sprinkled on food.

Dimethyl fumarate delayed-release capsules can be taken with or without food.

2.2Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [see Warnings and Precautions ( 5.4 )] . Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with dimethyl fumarate delayed-release capsules [see Warnings and Precautions ( 5.5 )] .

💊 Dosage Forms and Strengths 93 words ▾

3 DOSAGE FORMS AND STRENGTHS Dimethyl Fumarate Delayed-release Capsules, 120 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1204' in black ink and opaque white body. The capsules are filled with orange, round, coated tablets. Dimethyl Fumarate Delayed-release Capsules, 240 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1205' in black ink and opaque light green body.

The capsules are filled with orange, round, coated tablets. Delayed-release capsules : 120 mg and 240 mg ( 3 )

⛔ Contraindications 56 words ▾

4 CONTRAINDICATIONS Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate delayed-release capsules. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and angioedema: Discontinue and do not restart dimethyl fumarate delayed-release capsules if these occur. ( 5.1 ) Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl fumarate delayed-release capsules at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes zoster and other serious opportunistic infections: Consider withholding dimethyl fumarate delayed-release capsules in cases of serious infection until the infection has resolved.

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

Discontinue dimethyl fumarate delayed-release capsules if clinically significant liver injury induced by dimethyl fumarate delayed-release capsules is suspected. ( 5.5 )

5.1Anaphylaxis and Angioedema Dimethyl fumarate delayed-release capsules can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue dimethyl fumarate delayed-release capsules 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 delayed-release capsules. 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 delayed-release capsules for 4 years while enrolled in a clinical trial.

During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x10 9 /L for 3.5 years) while taking dimethyl fumarate delayed-release capsules [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 the postmarketing setting in the presence of lymphopenia (<0.9x10 9 /L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8x10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold dimethyl fumarate delayed-release capsules 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. 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 o…

🤒 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 ( 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 ( 5.5 )]. Flushing [see Warnings and Precautions ( 5.6 )].

Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate delayed-release capsules were flushing, abdominal pain, diarrhea, and nausea. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate delayed-release capsules with an overall exposure of 2244 person-years [see Clinical Studies ( 14 )].

The adverse reactions presented in the table below are based on safety information from 769 patients treated with dimethyl fumarate delayed-release capsules 240 mg twice a day and 771 placebo-treated patients. Table 1 Adverse Reactions in Study 1 and 2 reported for Dimethyl Fumarate Delayed-release Capsules 240 mg BID at ≥ 2% higher incidence than placebo Dimethyl Fumarate Delayed-release Capsules Placebo N=769 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 delayed-release capsules 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 delayed-release capsules compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate delayed-release capsules and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate delayed-release capsules.

Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate delayed-release capsules 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 delayed-release capsules and placebo and were balanced between groups.

There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1% and were similar in patients treated with dimethyl fumarate delayed-release capsules or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.

Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received dimethyl fumarate delayed-release capsules and been followed for periods up to 4 years with an overall ex…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight).

Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD.

Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identified.

The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD.

8.2Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dimethyl fumarate and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

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

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

🤰 Pregnancy ~1 min read ▾

The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD.

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 30 words ▾

🆘 Overdosage 64 words ▾

10 OVERDOSAGE Cases of overdose with dimethyl fumarate delayed-release capsules have been reported. The symptoms described in these cases were consistent with the known adverse event profile of dimethyl fumarate delayed-release capsules. There are no known therapeutic interventions to enhance elimination of dimethyl fumarate delayed-release capsules nor is there a known antidote.

In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have 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 Potential to prolong the QT interval In a placebo controlled thorough QT study performed in healthy subjects, there was no evidence that dimethyl fumarate caused QT interval prolongation of clinical significance (i.e., the upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 ms).

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

Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers. Absorption The median T max of MMF is 2 hours to 2.5 hours. The peak plasma concentration (C max ) and overall exposure (AUC) increased approximately dose proportionally in the dose range studied (120 mg to 360 mg).

Following administration of dimethyl fumarate delayed-release capsules 240 mg twice a day with food, the mean C max of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients. A high-fat, high-calorie meal did not affect the AUC of MMF but decreased its C max by 40%. The T max was delayed from 2 hours to 5.5 hours.

In this study, the incidence of flushing was reduced by approximately 25% in the fed state. Distribution The apparent volume of distribution of MMF varies between 53 and 73 L in healthy subjects. Human plasma protein binding of MMF is 27 % to 45% and independent of concentration.

Metabolism In humans, dimethyl fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, 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. MMF, fumaric and citric acid, and glucose are the major metabolites in plasma.

Elimination Exhalation of CO 2 is the primary route of elimination, accounting for approximately 60% of the dimethyl fumarate delayed-release capsules dose. Renal and fecal elimination are minor routes of elimination, accounting for 16% and 1% of the dose respectively. Trace amounts of unchanged MMF were present in urine.

The terminal half-life of MMF is approximately 1 hour and no circulating MMF is present at 24 hours in the majority of individuals. Accumulation of MMF does not occur with multiple doses of dimethyl fumarate delayed-release capsules. Specific Populations Body weight, gender, and age do not require dosage adjustment.

No studies have been conducted in subjects with hepatic or renal impairment. However, neither condition would be expected to affect exposure to MMF and therefore no dosage adjustment is necessary. Drug Interaction Studies No potential drug interactions with dimethyl fumarate or MMF were identified in in vitro CYP inhibition and induction studies, or in P-glycoprotein studies.

Single doses of interferon beta-1a or glatiramer acetate did not alter the pharmacokinetics of MMF. Aspirin, when administered approximately 30 minutes before dimethyl fumarate delayed-release capsules, did not alter the pharmacokinetics of MMF. Oral Contraceptives The coadministration of dimethyl fu…

🧬 Mechanism of Action 74 words ▾

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

📦 How Supplied / Storage and Handling 164 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dimethyl Fumarate Delayed-release Capsules, 120 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1204' in black ink and opaque white body. The capsules are filled with orange, round, coated tablets and are supplied as follows: 7-day bottle of 14 capsules (NDC 70710-1204-7) Dimethyl Fumarate Delayed-release Capsules, 240 mg are hard gelatin, delayed release, size '0' capsules with opaque light green cap printed with '1205' in black ink and opaque light green body.

The capsules are filled with orange, round, coated tablets and are supplied as follows: 23-day bottle of 46 capsules (NDC 70710-1205-8) 30-day bottle of 60 capsules (NDC 70710-1205-6) 30-Day Starter Pack (NDC 70710-1416-3) contains: 7-day bottle of 120 mg capsules with 14 capsules (Starter dose pack) NDC 70710-1204-1 23-day bottle of 240 mg capsules with 46 capsules (Regular dose pack) NDC 70710-1205-2 Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.

📋 Description 164 words ▾

11 DESCRIPTION Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate.

The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Image

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of dimethyl fumarate delayed-release capsules when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow dimethyl fumarate delayed-release capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food.

Inform patients that dimethyl fumarate delayed-release capsules can be taken with or without food [see Dosage and Administration ( 2.1 )]. Anaphylaxis and Angioedema Advise patients to discontinue dimethyl fumarate delayed-release capsules 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 occurred in patients who received dimethyl fumarate delayed-release capsules.

Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor 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 delayed-release capsules. 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 dimethyl fumarate delayed-release capsules 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 ), Adverse Reactions ( 6.1 )] . Liver Injury Inform patients that dimethyl fumarate delayed-release capsules may cause liver injury.

Instruct patients treated with dimethyl fumarate delayed-release capsules to report promptly 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 and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are 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 or GI reactions. Advise patients experiencing flushing that taking dimethyl fumarate delayed-release capsules with food or taking a non-enteric coated aspirin prior to taking dimethyl fumarate delayed-release capsules may help [see Adverse Reactions ( 6.1 )]. Pregnancy Instruct patients that if they are pregnant or plan to become pregnant while taking dimethyl fumarate delayed-release capsules they should inform their physician.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

CBC: A common blood test that measures red blood cells, white blood cells, and platelets.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

herpes zoster: The medical name for shingles, a painful rash caused by reactivation of the virus that causes chickenpox.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

immunocompromised: Having a weakened immune system, so the body is less able to fight off infections.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

lymphopenia: A low level of lymphocytes, a type of white blood cell that is important for immune defense.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

systemic circulation: The main bloodstream that carries a medicine throughout the whole body.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 70710-1204-07 · Zydus 70710-1208-01 · Zydus →

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.

dimethyl fumarate 240 mg Capsule, Delayed Release, 60-count

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