Home › NDC Lookup › Ingredients › Teriflunomide › 62332-0314-91

TERIFLUNOMIDE 14 mg Tablet, Film Coated, 1,000-count

by Alembic Pharmaceuticals Inc. · 1000 TABLET, FILM COATED in 1 BOTTLE (62332-314-91)

NDC 62332-0314-91

🏷️ FDA NDC (as labeled) 62332-314-91 billing pads the product segment with a zero

This package

Contains1,000-count Pack sizes3 compare ↓

Also priced by: Part D plans $4.21/unit — full pricing hub ↓

Also comes in: 14 tablets 62332-0314-14 30 tablets 62332-0314-30

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

⚠️

Other active recalls for Teriflunomide (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0334-2025

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-314-91

Product NDC 62332-314

11-digit billing NDC 62332031491

RxCUI 1310525, 1310533

UNII 1C058IKG3B

UPC 0362332313303, 0362332314300

Application # ANDA209572

SPL Set ID 8c1bc23b-a62b-4172-a603-8b97761514b4

Established class (EPC) Pyrimidine Synthesis Inhibitor

Mechanism of action Dihydroorotate Dehydrogenase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-01-25

Route ORAL

Dosage form TABLET, FILM COATED

Substance TERIFLUNOMIDE

GPI-14 62404070000330

GCN Seq No 069980

GCN 33262

HICL code 039624

Ingredient (HICL) Teriflunomide

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 90:04.20.00

AHFS class Antimetabolites

FDB label name TERIFLUNOMIDE 14 MG TABLET

FDB brand name Teriflunomide

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 62332-314-91 — 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 → 62332-0314-91. 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 Pyrimidine Synthesis Inhibitor class.

Pharmacologic class Pyrimidine Synthesis Inhibitor

Drug family (ATC) Dihydroorotate dehydrogenase (DHODH) inhibitors

How it works Dihydroorotate Dehydrogenase Inhibitors

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

LabelerAlembic Pharmaceuticals Inc.

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA209572 (ANDA)

Labeler code62332

First marketedJan 2023

Product typeHuman Prescription Drug

Portfolio491 products on file

🔎 All NDCs from Alembic Pharmaceuticals 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

Label name TERIFLUNOMIDE 14 MG TABLET Ingredient Teriflunomide

📗 Our plain-language guide HelloPharmacist

Teriflunomide helps reduce relapses in adults with relapsing forms of MS — including relapsing-remitting MS, clinically isolated syndrome, and active secondary progressive MS. It w...
What exactly does teriflunomide do for my MS?
No — teriflunomide cannot be taken during pregnancy. It has been shown to cause serious birth defects and fetal death in animal studies. Before you start, your doctor will confirm...
Can I take this medication if I'm pregnant or planning to become pregnant?

📖 Read our full Teriflunomide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

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

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

🌿 Every supplement checked against Teriflunomide (56 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 Blue

ShapePENTAGON (5 sided)

ImprintL;598

Size7 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 L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII UKE75GEA7F
Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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.

12 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	$4.21	$4,210.20 / 1000 tablets

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
Teriflunomide 14 mg 00480-3156-56	Teva	30 tablets	$0.242	AB	Availability likely	—
Teriflunomide 14 mg 31722-0247-30	Camber	30 tablets	$0.242	AB	Availability likely	—
Teriflunomide 14 mg 70377-0018-11	Biocon	30 tablets	$0.242	AB	Availability likely	—
Teriflunomide 14 mg 70710-1115-03	Zydus	30 tablets	$0.242	AB	Availability likely	—
Teriflunomide 14 mg 16729-0400-10	Accord	30 tablets	$0.693	AB	FDA listed	—
Teriflunomide 14 mg 00378-0628-93	Mylan	30 tablets	—	—	FDA listed	—
Teriflunomide 14 mg 42291-0831-30	AvKARE	30 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 46708-0314-14	Alembic	14 tablets	—	AB	FDA listed	—
Aubagio 14 mg 58468-0210-01	Genzyme	5 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 59651-0055-28	Aurobindo	28 tablets	—	AB	FDA listed	—
Teriflunomide 14 mgthis 62332-0314-91	Alembic	1000 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg/141 68254-5010-01	CONCORD	30 tablets	—	AB	FDA listed	—
teriflunomide 14 mg 68462-0424-15	Glenmark	14 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 69339-0170-03	Natco	30 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 69539-0033-41	MSN	14 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 69539-0316-30	MSN	30 tablets	—	AB	FDA listed	—
Teriflunomide 14 mg 70771-1011-03	Zydus	30 tablets	—	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

🏛️

2023

On the market since

Jan 2023

📍

2026

Currently FDA-listed

3 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.

💊 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.

30 tablets62332-0314-30 2,061 Rx · $823,830

14 tablets62332-0314-14 No Medicaid data

1000 tablets this page62332-0314-91 No Medicaid data

Drug total (last 4 qtrs): 2,061 Rx · 68,912 units · $823,830 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 Teriflunomide — the program that covers self-administered drugs. 7 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 Teriflunomide. 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

$11.61M

Claims incl. refills

16.2K

Beneficiaries

6.5K

Spend / beneficiary

$1,777.83

Spend / claim

$714.99

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
62332-0314-14	2 BLISTER PACK in 1 CARTON (62332-314-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK	—	—	2023-01-25	Active
62332-0314-30	30 TABLET, FILM COATED in 1 BOTTLE (62332-314-30)	$0.2415 / ea	$7.25	2023-01-25	Active
62332-0314-91 You're viewing this	1000 TABLET, FILM COATED in 1 BOTTLE (62332-314-91)	—	—	2023-01-25	Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0314-91?

NDC 62332-0314-91 is a 1,000-count package — 1000 tablet, film coated in 1 bottle.

What is the difference between NDC 62332-0314-91 and NDC 62332-0314-30?

Both are TERIFLUNOMIDE 14 mg Tablet, Film Coated — the drug itself is identical. NDC 62332-0314-91 is the 1,000-count package, while NDC 62332-0314-30 is the 30 tablets package.

What NDC number is used to bill for this package of TERIFLUNOMIDE 14 mg Tablet, Film Coated?

Bill NDC 62332-0314-91 — the 11-digit billing format is 62332031491. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— 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 62332-314-91, 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: 62332-0314-91, written without dashes as 62332031491. 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 62332-0314-91, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0314) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (91) 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 Alembic Pharmaceuticals 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 2 other package presentations of this same product, including 14 tablets (62332-0314-14), 30 tablets (62332-0314-30). 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?

Alembic Pharmaceuticals 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.

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

🚨 Boxed Warning ~2 min read ▾

WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting [see Warnings and Precautions (5.1)] . Concomitant use of teriflunomide with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy.

Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1)]. If drug induced liver injury is suspected, discontinue teriflunomide tablets and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3)]. Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4)].

Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets. • Embryofetal Toxicity Teriflunomide tablets are contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with teriflunomide tablets in females of reproductive potential.

Advise females of reproductive potential to use effective contraception during teriflunomide tablets treatment and during an accelerated drug elimination procedure after teriflunomide tablets treatment. Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4), Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1, 8.3), and Clinical Pharmacology (12.3)]. WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY See full prescribing information for complete boxed warning. • Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting ( 5.1 ).

Concomitant use of teriflunomide with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets and monitor ALT levels at least monthly for six months ( 5.1 ). If drug induced liver injury is suspected, discontinue teriflunomide tablets and start accelerated elimination procedure ( 5.3 ). • Embryofetal Toxicity Teratogenicity and embryolethality occurred in animals administered teriflunomide ( 5.2 , 8.1 ).

Exclude pregnancy prior to initiating teriflunomide therapy ( 4 , 5.2 , 8.1 , 8.3 ). Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure ( 4 , 5.2 , 5.3 , 8.1 , 8.3 ). Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant ( 5.2 , 5.3 , 8.1 ).

🎯 Indications and Usage 67 words ▾

1 INDICATIONS AND USAGE Teriflunomide tablets are 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. Teriflunomide tablet is a pyrimidine synthesis inhibitor 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 183 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of teriflunomide tablet is 7 mg or 14 mg orally once daily. Teriflunomide tablets can be taken with or without food. Monitoring to Assess Safety Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy.

Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1)] . Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with teriflunomide tablets. Further monitoring should be based on signs and symptoms of infection [see Warnings and Precautions (5.4)] .

Prior to initiating teriflunomide tablets, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4)] . Exclude pregnancy prior to initiation of treatment with teriflunomide tablets in females of reproductive potential [see Warnings and Precautions (5.2)] . Check blood pressure before start of teriflunomide tablets treatment and periodically thereafter [see Warnings and Precautions (5.10)] .

7 mg or 14 mg orally once daily, with or without food. ( 2 )

💊 Dosage Forms and Strengths 88 words ▾

3 DOSAGE FORMS AND STRENGTHS Teriflunomide tablets are available as 7 mg and 14 mg tablets. The 7 mg tablet is pale blue to pastel blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side. Each tablet contains 7 mg of teriflunomide.

The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side. Each tablet contains 14 mg of teriflunomide. 7 mg and 14 mg film-coated tablets ( 3 )

⛔ Contraindications 126 words ▾

4 CONTRAINDICATIONS Teriflunomide tablet is contraindicated in/with: ● Patients with severe hepatic impairment [see Warnings and Precautions (5.1)] . ● Pregnant women and females of reproductive potential not using effective contraception. Teriflunomide tablet may cause fetal harm [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.1)] . ● Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. Reactions have included anaphylaxis, angioedema, and serious skin reactions [see Warnings and Precautions (5.5)]. ● Coadministration with leflunomide [see Clinical Pharmacology (12.3)]. • Severe hepatic impairment ( 4 , 5.1 ) • Pregnancy ( 4 , 5.2 , 8.1 ) • Hypersensitivity ( 4 , 5.5 ) • Current leflunomide treatment ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Elimination of teriflunomide tablets can be accelerated by administration of cholestyramine or activated charcoal for 11 days. ( 5.3 ) • Teriflunomide tablets may decrease WBC. A recent CBC should be available before starting teriflunomide tablets.

Monitor for signs and symptoms of infection. Consider suspending treatment with teriflunomide tablets in case of serious infection. Do not start teriflunomide tablets in patients with active infections.

( 5.4 ) • Stop teriflunomide tablets if patient has anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms; initiate rapid elimination. ( 5.3 , 5.5 , 5.6 , 5.7 ) • Cutaneous or mucocutaneous ulcers/impaired wound healing: If ulcer or impaired wound healing is suspected, consider discontinuation of teriflunomide tablets treatment and an accelerated drug elimination procedure. ( 5.8 ) • If patient develops symptoms consistent with peripheral neuropathy, evaluate patient and consider discontinuing teriflunomide tablets.

( 5.9 ) • Teriflunomide tablets may increase blood pressure. Measure blood pressure at treatment initiation and monitor blood pressure during treatment. ( 5.10 )

5.1Hepatotoxicity Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting. Patients with pre-existing liver disease and patients taking other hepatotoxic drugs may be at increased risk for developing liver injury when taking teriflunomide tablets. Clinically significant liver injury can occur at any time during treatment with teriflunomide tablets.

Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with teriflunomide tablets. Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4)] . In placebo-controlled trials in adult patients, ALT greater than three times the ULN occurred in 61/1,045 (5.8%) and 62/1,002 (6.2%) of patients receiving teriflunomide tablets 7 mg and 14 mg, respectively, and 38/997 (3.8%) of patients receiving placebo, during the treatment period.

These elevations occurred mostly within the first year of treatment. Half of the cases returned to normal without drug discontinuation. In clinical trials, if ALT elevation was greater than three times the ULN on two consecutive tests, teriflunomide tablet was discontinued and patients underwent an accelerated elimination procedure [see Warnings and Precautions (5.3)] .

Of the patients who underwent discontinuation and accelerated elimination in controlled trials, half returned to normal or near normal values within 2 months. One patient in the controlled trials in adult patients developed ALT 32 times the ULN and jaundice 5 months after initiation of teriflunomide tablets 14 mg treatment. The patient was hospitalized for 5 weeks and recovered after plasmapheresis and cholestyramine accelerated elimination procedure.

Teriflunomide tablets-induced liver injury in this patient could not be ruled out. Obtain serum transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets.

Consider additional monitoring when teriflunomide tablets are given with other potentially hepatotoxic drugs. Consider discontinuing teriflunomide tablets if serum transaminase increase (greater than three times the ULN) is confirmed. Monitor serum transaminase and bilirubin on teriflunomide tablets therapy, particularly in patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the prescribing information: • Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1)] • Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4)] • Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.5)] • Serious Skin Reactions [see Warnings and Precautions (5.6)] • Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.7)] • Cutaneous or Mucocutaneous Ulcers and Impaired Wound Healing [see Warnings and Precautions (5.8)] • Peripheral Neuropathy [see Warnings and Precautions (5.9)] • Increased Blood Pressure [see Warnings and Precautions (5.10)] • Respiratory Effects [see Warnings and Precautions (5.11)] • Pancreatitis in Pediatric Patients [see Warnings and Precautions (5.12)] Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 2,047 patients receiving teriflunomide tablets (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo-controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female.

The average age was 37 years. Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for teriflunomide tablets patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea.

The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the teriflunomide tablets 7 mg, teriflunomide tablets 14 mg, and placebo treatment arms, respectively). Table 1: Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis Adverse Reaction Teriflunomide Tablets 7 mg (N=1,045) Teriflunomide Tablets 14 mg (N=1,002) Placebo (N=997) Headache 18% 16% 15% Increase in Alanine aminotransferase 13% 15% 9% Diarrhea 13% 14% 8% Alopecia 10% 13% 5% Nausea 8% 11% 7% Paresthesia 8% 9% 7% Arthralgia 8% 6% 5% Neutropenia 4% 6% 2% Hypertension 3% 4% 2% Cardiovascular Deaths Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2,600 patients exposed to teriflunomide tablets in the premarketing database.

These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between teriflunomide tablets and cardiovascular death has not been established. Acute Renal Failure In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1,045 (0.8%) patients in the 7 mg teriflunomide tablets group and 6/1,002 (0.6%) patients in the 14 mg teriflunomide tablets group versus 4/997 (0.4%) patients in the placebo group.

These elevations were transient. Some elevations were accompanied by hyperkalemia. Teriflunomide tablets may cause acute uric acid nephropathy with transient acute renal failure because teriflunomide tablets increases renal uric acid clearance.

Hypophosphatemia In clinical trials, 18% of teriflunomide tablets-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of teriflunomide tablets-tr…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Effect of Teriflunomide Tablets on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3)] .

Effect of Teriflunomide Tablets on Warfarin Coadministration of teriflunomide tablets with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide tablets may decrease peak INR by approximately 25%. Effect of Teriflunomide Tablets on Oral Contraceptives Teriflunomide tablets may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with teriflunomide tablets [see Clinical Pharmacology (12.3)] .

Effect of Teriflunomide Tablets on CYP1A2 Substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo . In patients taking teriflunomide tablets, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3)] .

Effect of Teriflunomide Tablets on Organic Anion Transporter 3 (OAT3) Substrates Teriflunomide inhibits the activity of OAT3 in vivo . In patients taking teriflunomide tablets, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3)] .

Effect of Teriflunomide Tablets on BCRP and Organic Anion Transporting Polypeptide B1 and B3 (OATP1B1/1B3) Substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo . For a patient taking teriflunomide tablets, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking teriflunomide tablets [see Clinical Pharmacology (12.3)] . • Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs.

( 7 ) • Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive. ( 7 ) • Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs.

( 7 ) • Warfarin: Monitor INR as teriflunomide may decrease INR. ( 7 ) • Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) • Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking teriflunomide tablets.

( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Teriflunomide tablets are contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data [see Contraindications (4) and Warnings and Precautions (5.2)]. In animal reproduction studies in rat and rabbit, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum recommended human dose (MRHD) of 14 mg/day [see Data].

Available human data from pregnancy registries, clinical trials, pharmacovigilance cases, and published literature are too limited to draw any conclusions, but they do not clearly indicate increased birth defects or miscarriage associated with inadvertent teriflunomide exposure in the early first trimester when followed by an accelerated elimination procedure [see Clinical Considerations and Data]. There are no human data pertaining to exposures later in the first trimester or beyond. In the US general population, the estimated backgrou nd 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 in the indicated population is unknown. Clinical Considerations Fetal/Neonatal adverse reactions Lowering the plasma concentration of teriflunomide by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease the risk to the fetus from teriflunomide tablets. The accelerated drug elimination procedure includes verification that the plasma teriflunomide concentration is less than 0.02 mg/L [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Data Human data Available human data are limited. Prospectively reported data (from clinical trials and postmarketing reports) from >150 pregnancies in patients treated with teriflunomide and > 300 pregnancies in patients treated with leflunomide have not demonstrated an increased rate of congenital malformations or miscarriage following teriflunomide exposure in the early first trimester when followed by an accelerated elimination procedure. Specific patterns of major congenital malformations in humans have not been observed.

Limitations of these data include an inadequate number of reported pregnancies from which to draw conclusions, the short duration of drug exposure in reported pregnancies, which precludes a full evaluation of the fetal risks, incomplete reporting, and the inability to control for confounders (such as underlying maternal disease and use of concomitant medications). Animal data When teriflunomide (oral doses of 1, 3, or 10 mg/kg/day) was administered to pregnant rats throughout the period of organogenesis, high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and fetal death were observed at doses not associated with maternal toxicity.

Adverse effects on fetal development were observed following dosing at various stages throughout organogenesis. Maternal plasma exposure at the no-effect level (1 mg/kg/day) for fetal developmental toxicity in rats was less than that in humans at the maximum recommended human dose (MRHD, 14 mg/day). Administration of teriflunomide (oral doses of 1, 3.5, or 12 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in high incidences of fetal malformation (primarily craniofacial, and axial and appendicular skeletal defects) and fetal death at doses associated with minimal maternal toxicity.

Maternal plasma exposure at the no-effect dose (1 mg/kg/day) for fetal developmental toxicity in rabbits was less than that in humans at the MRHD. In studies in which teriflunomide (oral doses of 0.05, 0.1, 0.3, 0.6, or 1 mg/kg/day) was administered to rats during gestation and lactation, decreased growth, eye and skin abnormalities, and high inci…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Effectiveness of teriflunomide tablets for the treatment of relapsing form of multiple sclerosis in pediatric patients (10 to 17 years of age) was not established in an adequate and well-controlled clinical study in 166 patients (109 patients received once-daily doses of teriflunomide tablets and 57 patients received placebo) for up to 96 weeks. Pancreatitis has been reported in adults in the postmarketing setting, but appears to occur at higher frequency in the pediatric population.

In this pediatric study, cases of pancreatitis were reported in 1.8% (2/109) of patients who received teriflunomide tablets compared to no patients in the placebo group. All patients in the pediatric trial recovered or were recovering after treatment discontinuation and accelerated elimination procedure [see Warnings and Precautions (5.12)] . Additionally, elevated or abnormal blood creatine phosphokinase was reported in 6.4% of pediatric patients who received teriflunomide tablets compared to no patients in the placebo group.

Juvenile Animal Toxicity Data Oral administration of teriflunomide (0, 0.3, 3, or 6 mg/kg/day) to young rats on postnatal days 21 to 70 resulted in suppression of immune function (T-cell dependent antibody response) at the mid and high doses, and adverse effects on male reproductive organs (reduced sperm count) and altered neurobehavioral function (increased locomotor activity) at the high dose. At the no-effect dose (0.3 mg/kg/day) for developmental toxicity in juvenile rats, plasma exposures were less than those in pediatric patients at the doses of teriflunomide tablets tested in the clinical study.

🧓 Geriatric Use 16 words ▾

8.5Geriatric Use Clinical studies of teriflunomide tablets did not include patients over 65 years old.

🆘 Overdosage 51 words ▾

10 OVERDOSAGE There is no experience regarding teriflunomide overdose or intoxication in humans. Teriflunomide 70 mg daily up to 14 days was well tolerated by healthy subjects. In the event of clinically significant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination [see Warnings and Precautions (5.3)] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.

12.2Pharmacodynamics Potential to Prolong the QT Interval In a placebo-controlled thorough QT study performed in healthy adult subjects, there was no evidence that teriflunomide 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 Teriflunomide is the principal active metabolite of leflunomide and is responsible for leflunomide’s activity in vivo . At recommended doses, teriflunomide and leflunomide result in a similar range of plasma concentrations of teriflunomide. Based on a population analysis of teriflunomide in healthy adult volunteers and adult MS patients, median t 1/2 was approximately 18 and 19 days after repeated doses of 7 mg and 14 mg respectively.

It takes approximately 3 months respectively to reach steady-state concentrations. The estimated AUC accumulation ratio is approximately 30 after repeated doses of 7 or 14 mg. Absorption Median time to reach maximum plasma concentrations is between 1 to 4 hours post dose following oral administration of teriflunomide.

Food does not have a clinically relevant effect on teriflunomide pharmacokinetics. Distribution Teriflunomide is extensively bound to plasma protein (>99%) and is mainly distributed in plasma. The volume of distribution is 11 L after a single intravenous (IV) administration.

Metabolism Teriflunomide is the major circulating moiety detected in plasma. The primary biotransformation pathway to minor metabolites of teriflunomide is hydrolysis, with oxidation being a minor pathway. Secondary pathways involve oxidation, N-acetylation and sulfate conjugation.

Elimination Teriflunomide is eliminated mainly through direct biliary excretion of unchanged drug as well as renal excretion of metabolites. Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%). After an accelerated elimination procedure with cholestyramine, an additional 23.1% was recovered (mostly in feces).

After a single IV administration, the total body clearance of teriflunomide is 30.5 mL/h. Drug Interaction Studies Teriflunomide is not metabolized by Cytochrome P450 or flavin monoamine oxidase enzymes. The potential effect of teriflunomide tablets on other drugs CYP2C8 substrates There was an increase in mean repaglinide C max and AUC (1.7-and 2.4-fold, respectively) following repeated doses of teriflunomide and a single dose of 0.25 mg repaglinide, suggesting that teriflunomide is an inhibitor of CYP2C8 in vivo .

The magnitude of interaction could be higher at the recommended repaglinide dose [see Drug Interactions (7)] . CYP1A2 substrates Repeated doses of teriflunomide decreased mean C max and AUC of caffeine by 18% and 55%, respectively, suggesting that teriflunomide may be a weak inducer of CYP1A2 in vivo [see Drug Interactions (7)] . OAT3 substrates There was an increase in mean cefaclor C max and AUC (1.43-and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of organic anion transporter 3 (OAT3) in vivo [see Drug Interactions (7)] .

BCRP and OATP1B1/1B3 substrates There was an increase in mean rosuvastatin C max and AUC (2.65-and 2.51-fold, respectively) following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of BCRP transporter and organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1/1B3) [see Drug Interactions (7)] . Oral contraceptives There was an increase in mean ethinylestradiol C max and…

🧬 Mechanism of Action 51 words ▾

📦 How Supplied / Storage and Handling 176 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Teriflunomide tablets are available as 7 mg and 14 mg tablets. The 7 mg tablet is pale blue to pastel blue, hexagonal film-coated tablet debossed with “L” on one side and “597” on other side. Each tablet contains 7 mg of teriflunomide.

Teriflunomide tablets 7 mg are supplied as: NDC 62332-313-14 Carton of 28 tablets containing 1 wallet composed of 2 folded blister cards of 14 tablets per blister card NDC 62332-313-30 Bottle of 30 tablets with child-resistant closure The 14 mg tablet is pale blue to pastel blue, pentagonal film-coated tablet debossed with “L” on one side and “598” on other side. Each tablet contains 14 mg of teriflunomide. Teriflunomide tablets 14 mg are supplied as: NDC 62332-314-14 Carton of 28 tablets containing 1 wallet composed of2 folded blister cards of 14 tablets per blister card NDC 62332-314-30 Bottle of 30 tablets with child-resistant closure NDC 62332-314-91 Bottle of 1,000 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] .

📋 Description 146 words ▾

11 DESCRIPTION Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C 12 H 9 F 3 N 2 O 2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration.

Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 14 mg tablet is made of FD&C Blue#2 Aluminium Lake, hypromellose, polyethylene glycol 8000, talc, and titanium dioxide. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.

Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). A Medication Guide is required for distribution with teriflunomide tablets. Hepatotoxicity Inform patients that teriflunomide tablets may cause liver injury, which can be life-threatening, and that their liver enzymes will be checked before starting teriflunomide tablets and at least monthly for 6 months after starting teriflunomide tablets [see Dosage and Administration (2) and Warnings and Precautions (5.1)].

Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. Embryofetal Toxicity • Advise females of reproductive potential o of the potential for fetal harm if teriflunomide tablets are taken during pregnancy o to notify their healthcare provider immediately if a pregnancy occurs or is suspected o to use effective contraception during treatment with teriflunomide tablets and until the teriflunomide plasma concentration is verified to be less than 0.02 mg/L [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.1, 8.3), Clinical Pharmacology (12.3)]. • Instruct men taking teriflunomide tablets and not wishing to father a child to use effective contraception to minimize any possible risk to the fetus; their female partners should also use effective contraception. • Advise men wishing to father a child to discontinue use of teriflunomide tablets and undergo an accelerated elimination procedure.

Availability of an Accelerated Elimination Procedure Advise patients that teriflunomide tablets may stay in the blood for up to 2 years after the last dose and that an accelerated elimination procedure may be used if needed [see Warnings and Precautions (5.3)] . Risk of Infections Inform patients that they may develop a lowering of their white blood cell counts and that their blood counts will be checked before starting teriflunomide tablets. Inform patients that they may be more likely to get infections when taking teriflunomide tablets and that they should contact their physician if they develop symptoms of infection, particularly in case of fever [see Warnings and Precautions (5.4)].

Advise patients that the use of some vaccines should be avoided during treatment with teriflunomide tablets and for at least 6 months after discontinuation. Hypersensitivity Reactions Advise patients to discontinue teriflunomide tablets and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur [see Contraindications (4) and Warnings and Precautions (5.5)]. Signs and symptoms can include dyspnea, urticaria, angioedema involving the lips, eyes, throat, or tongue, or skin rash.

Serious Skin Reactions Advise patients to discontinue teriflunomide tablets and seek immediate medical attention if any signs of a serious skin reaction, such as SJS or TEN, occur [see Warnings and Precautions (5.6)] . Signs and symptoms can include rash, mouth sores, blisters, or peeling skin. DRESS/Multi-organ Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately.

Teriflunomide tablets should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions (5.7)] . Cutaneous and Mucocutaneous Ulcers and Impaired Wound Healing Advise patients to seek medical attention if they develop cutaneous or mucocutaneous ulcers or experience impaired wound healing after a surgery [see Warnings and Precautions (5.8)] . Peripheral Neuropathy Inform patients that they may develop peripheral neuropathy.

Advise patients that they should contact their physician if they develop symptoms of peripheral neuropathy, such as numbness or tingling of hands or feet [see Warnings and…

💬 Medication Guide ~3 min read ▾

Medication Guide Teriflunomide (ter” i floo’ noe mide) Tablets, for oral use Read this Medication Guide before you start using teriflunomide tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about teriflunomide tablets? Teriflunomide tablets may cause serious side effects, including: ● Liver problems: Teriflunomide tablets may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk of developing serious liver problems may be higher if you already have liver problems or take other medicines that also affect your liver.

Your healthcare provider should do blood tests to check your liver: o within 6 months before you start taking teriflunomide tablets o 1 time a month for 6 months after you start taking teriflunomide tablets Call your healthcare provider right away if you have any of the following symptoms of liver problems: o nausea o vomiting o stomach pain o loss of appetite o tiredness o your skin or the whites of your eyes turn yellow o dark urine ● Harm to your unborn baby: Teriflunomide tablets may cause harm to your unborn baby.

Do not take teriflunomide tablets if you are pregnant. Do not take teriflunomide tablets unless you are using effective birth control. o If you are a female, you should have a pregnancy test before you start taking teriflunomide tablets. Use effective birth control during your treatment with teriflunomide tablets. o After stopping teriflunomide tablets, continue using effective birth control until you have blood tests to make sure your blood levels of teriflunomide tablets are low enough. o If you become pregnant while taking teriflunomide tablets or within 2 years after you stop taking it, tell your healthcare provider right away. o For men taking teriflunomide tablets: ● If your female partner plans to become pregnant, you should stop taking teriflunomide tablets and ask your healthcare provider how to quickly lower the levels of teriflunomide tablets in your blood. ● If your female partner does not plan to become pregnant, you and your female partner should use effective birth control during your treatment with teriflunomide tablets.

Teriflunomide tablets remains in your blood after you stop taking it, so continue using effective birth control until teriflunomide tablets blood levels have been checked and they are low enough. Teriflunomide tablets may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine to help lower your blood levels of teriflunomide tablets more quickly.

Talk to your healthcare provider if you want more information about this. What is teriflunomide tablet? ● Teriflunomide tablet is a prescription medicine used to treat 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 teriflunomide tablets are safe and effective in children. Who should not take teriflunomide tablets?

Do not take teriflunomide tablet if you: ● have severe liver problems. ● are pregnant or are of childbearing age and not using effective birth control. ● have had an allergic reaction to leflunomide, teriflunomide or any other ingredients in teriflunomide tablets. Please see the end of this Medication Guide for a complete list of ingredients in teriflunomide tablets. ● take a medicine called leflunomide. Before you take teriflunomide tablets, tell your healthcare provider about all of your medical conditions, including if you : ● have liver or kidney problems. ● have a fever or infection, or you are unable to fight infections. ● have numbness or tingling in your hands or feet that is different from your MS symptoms. ● have diabetes. ● have had serio…

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.

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 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.

alopecia: Loss of hair from the scalp or body.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

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.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

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

arthralgia: Joint pain.

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.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

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

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

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

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

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

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

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

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.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

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.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

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

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

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

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

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

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypophosphatemia: A lower-than-normal level of phosphate, a mineral, in the blood.

immunosuppression: A weakening of the body's defense system, which makes it harder to fight off infections.

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

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

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.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

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

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

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.

mucocutaneous: Involving both the skin and the moist linings of the body, such as the mouth, eyes, or nose.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

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

neonatal: Relating to a newborn baby during its first four weeks of life.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

OATP: A group of transporter proteins that carry certain drugs into cells, especially in the liver.

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.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

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

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

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.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

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

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

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

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

tuberculosis: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

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 ↗

← 62332-0313-14 · Alembic 62332-0315-30 · Alembic →

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.

TERIFLUNOMIDE 14 mg Tablet, Film Coated, 1,000-count

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