Home › NDC Lookup › Ingredients › Avacopan › 73556-0168-96
TAVNEOS avacopan 10 mg Capsule, 30-count — NDC 73556-0168-96 package photo

TAVNEOS avacopan 10 mg Capsule, 30-count

by ChemoCentryx, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC
NDC 73556-0168-96
🏷️ FDA NDC (as labeled) 73556-168-96 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $105.85/unit — full pricing hub ↓
Also comes in: 30 capsules 73556-0168-02 180 capsules 73556-0168-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 73556-168-96
Product NDC 73556-168
11-digit billing NDC 73556016896
RxCUI 2572105, 2572111
UNII O880NM097T
Application # NDA214487
SPL Set ID c93cbc0b-29a3-46a5-9c85-41815ea5cf4a
Established class (EPC) Complement 5a Receptor Antagonist
Mechanism of action Complement 5a Receptor Antagonists; Cytochrome P450 3A4 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-18
Route ORAL
Dosage form CAPSULE
Substance AVACOPAN
GPI-14 85805510000120
GPI class Tavneos
GCN Seq No 082745
GCN 51334
HICL code 047626
Ingredient (HICL) Avacopan
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0L
Therapeutic class — specific (HIC3) Complement Inhibitors
AHFS code 90:20.00.00
AHFS class Complement Inhibitor Agents (90:20)
FDB label name TAVNEOS 10 MG CAPSULE
FDB brand name Tavneos
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 73556-168-96 — 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 → 73556-0168-96. 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 Complement 5a Receptor Antagonist class.

Pharmacologic class Complement 5a Receptor Antagonist
Drug family (ATC) Complement inhibitors
How it works Cytochrome P450 3A4 Inhibitors, Complement 5a Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerChemoCentryx, Inc.
Application holderCHEMOCENTRYX INC
FDA applicationNDA214487 (NDA)
Labeler code73556
First marketedOct 2021
Product typeHuman Prescription Drug
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 TAVNEOS 10 MG CAPSULE Ingredient Avacopan
📖 What it is MedlinePlus · NLM

Avacopan is used to treat granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis, conditions in which the body attacks its own veins and other blood vessels, that can cause damage to organs, such as the heart and lungs. Avacopan is in a class of medications called complement inhibitors. It works by blocking the activity of the part of the immune system that may damage veins and other blood vessels.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Tavneos is used to treat a serious autoimmune disease called ANCA-associated vasculitis — specifically the types known as GPA and MPA — where your immune system attacks your own bl...
  • What exactly is Tavneos used for, and why do I still need to take steroids?
  • Yes, it genuinely matters. Taking Tavneos with food — especially a full meal — significantly increases how much of the medicine your body actually absorbs. If you take it on an emp...
  • Do I need to take Tavneos with food? Does it matter if I don't?
📖 Read our full Avacopan guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Orange / Yellow
ShapeCapsule
ImprintCCX168
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 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 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo 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 $105.85 $3,175.55 / 30 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tavneos 10 mgthis 73556-0168-96 ChemoCentryx, 30 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
First FDA approval
Oct 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 7, 2021 RLD RS ⏳ ~13.2 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 11603356 — drug substance (U-3558)
US 11951214 — drug product
US 8906938 — drug substance
US 8445515 — drug substance
Exclusivity NCE
Exclusivity ODE-377
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

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

Listed patents (4)
PatentTypeUse codeExpires
US 11603356 ↗ Drug substance U-3558 Nov 27, 2039
US 11951214 ↗ Drug product — Nov 27, 2039
US 8906938 ↗ Drug substance — Jan 6, 2034
US 8445515 ↗ Drug substance — Feb 3, 2031
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Oct 7, 2026
ODE-377Orphan Drug Exclusivity (7-year)Oct 7, 2028
Common questions
Is there a generic version of TAVNEOS 10 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TAVNEOS 10 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization 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.
180 capsules73556-0168-01 1,629 Rx · $28,010,232
30 capsules73556-0168-02 No Medicaid data
30 capsules this page73556-0168-96 No Medicaid data
Drug total (last 4 qtrs): 1,629 Rx · 287,250 units · $28,010,232 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 Tavneos — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tavneos. 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
$82.27M
Claims incl. refills
4.5K
Beneficiaries
1.9K
Spend / beneficiary
$44,019.71
Spend / claim
$18,335.82
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 TAVNEOS (this brand).

Top reported reactions

Hospitalisation931
Death381
Therapy Interrupted291
Diarrhoea259
Fatigue252
Nausea243
Pneumonia223

Age at onset

Neonate1
Child8
Adolescent16
Adult1,063
Elderly1,496

Reporter sex

6,343 reports
Male · 43%
Female · 57%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,726 8
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
73556-0168-01 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 Active
73556-0168-02 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 Active
73556-0168-96 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC 2021-10-18 Active

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

Pack size FAQ

What quantity is in NDC 73556-0168-96?
NDC 73556-0168-96 is a 30-count package — 1 bottle, plastic in 1 carton / 30 capsule in 1 bottle, plastic.
What is the difference between NDC 73556-0168-96 and NDC 73556-0168-02?
Both are TAVNEOS avacopan 10 mg Capsule — the drug itself is identical. NDC 73556-0168-96 is the 30-count package, while NDC 73556-0168-02 is the 30 capsules package.
What NDC number is used to bill for this package of TAVNEOS avacopan 10 mg Capsule?
Bill NDC 73556-0168-96 — the 11-digit billing format is 73556016896. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — 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 73556-168-96, 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: 73556-0168-96, written without dashes as 73556016896. 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 73556-0168-96, the first segment (73556) is the labeler code FDA assigned to ChemoCentryx, Inc.; the middle segment (0168) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (96) 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 ChemoCentryx, 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 30 capsules (73556-0168-02), 180 capsules (73556-0168-01). 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?
ChemoCentryx, 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 91 words ▾

1 INDICATIONS AND USAGE TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS is a complement 5a receptor (C5aR) antagonist indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.

TAVNEOS does not eliminate glucocorticoid use. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 30 mg (three 10 mg capsules) twice daily, with food. ( 2 )

2.1Recommended Evaluations Prior to Treatment Initiation Before initiating TAVNEOS, perform the following evaluations: Liver Function Tests: Obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) before initiating TAVNEOS. TAVNEOS is not recommended for use in patients with cirrhosis, especially those with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7) ] . Hepatitis B (HBV) Serology: Screen patients for HBV infection by measuring HBsAg and anti-HBc .

For patients with evidence of prior or current HBV infection, consult with a physician with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before or during treatment with TAVNEOS [see Warnings and Precautions (5.3) ] .

2.2Recommended Dosage and Administration The recommended dose of TAVNEOS is 30 mg (three 10 mg capsules) twice daily, with food. Advise patients that TAVNEOS capsules should not be crushed, chewed or opened. If a dose is missed, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.

2.3Dosage Modifications Due to CYP3A4 Inhibitors Reduce the dosage of TAVNEOS to 30 mg once daily when used concomitantly with strong CYP3A4 inhibitors.

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 10 mg, opaque, yellow and light orange with CCX168 printed in black. Capsules: 10 mg ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS TAVNEOS is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients [see Warnings and Precautions (5.2) ] . Serious hypersensitivity to avacopan or to any of the excipients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Increase in liver function tests occurred in clinical trials. Obtain liver function tests before initiation of therapy and monitor as clinically indicated. ( 5.1 ) Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial.

Observe for signs and symptoms of angioedema and manage accordingly. ( 5.2 ) Hepatitis B Virus (HBV) Reactivation: Cases of HBV reactivation occurred in a clinical trial. Withhold TAVNEOS and institute appropriate anti-infective therapy.

( 5.3 ) Serious Infections: Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. ( 5.4 )

5.1Hepatotoxicity Serious cases of hepatic injury have been observed in patients taking TAVNEOS. During controlled trials, the TAVNEOS treatment group had a higher incidence of transaminase elevations and hepatobiliary events, including serious and life-threatening events [see Adverse Reactions (6.1) ] . In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported.

These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS [see Adverse Reactions (6.2) ] . Obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and total bilirubin) before initiating TAVNEOS, every 4 weeks after start of therapy for the first 6 months of treatment and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter.

If a patient receiving treatment with TAVNEOS presents with an elevation in ALT or AST to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or ALP ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out [see Adverse Reactions (6.1) ] .

Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering TAVNEOS to a patient with liver disease.

Monitor patients closely for hepatic adverse reactions [see Use in Specific Populations (8.7) ] .

5.2Hypersensitivity Reactions TAVNEOS may cause angioedema [see Adverse Reactions (6.1) ] . In clinical trials, two cases of angioedema occurred, including one serious event requiring hospitalization. If angioedema occurs, discontinue TAVNEOS immediately, provide appropriate therapy, and monitor for airway compromise.

TAVNEOS must not be re-administered unless another cause has been established. Educate patients on recognizing the signs and symptoms of a hypersensitivity reaction and to seek immediate medical care should they develop.

5.3Hepatitis B Virus (HBV) Reactivation Hepatitis B virus (HBV) reactivation, including life-threatening hepatitis B, was observed in the clinical program. HBV reactivation is defined as an abrupt increase in HBV replication, manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg, in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels.

In severe cases, increase in bilirubin levels, liver failure, and death can occur. Screen patients for HBV…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Hepatitis B Virus (HBV) Reactivation [see Warnings and Precautions (5.3) ] Serious Infections [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%) are: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because the clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The identification of potential adverse drug reactions was based on safety data from the phase 3 clinical trial in which 330 patients with ANCA-associated vasculitis were randomized 1:1 to either TAVNEOS or prednisone [see Clinical Studies (14) ] .

The mean age of patients was 60.9 years (range of 13 to 88 years), with a predominance of men (56.4%) and Caucasians (84.2%). The cumulative exposure to TAVNEOS was 138.7 patient-years. Additionally, two phase 2 trials were conducted in ANCA-associated vasculitis.

The cumulative clinical trial exposure from the phase 2 and 3 trials equals 212.3 patient-years. The most frequent serious adverse reactions reported more frequently in patients treated with TAVNEOS than with prednisone were pneumonia (4.8% TAVNEOS vs. 3.7% prednisone), GPA (3.0% TAVNEOS vs.

0.6% prednisone), acute kidney injury (1.8% TAVNEOS vs. 0.6% prednisone), and urinary tract infection (1.8% TAVNEOS vs. 1.2% prednisone).

Within 52 weeks, 4 patients in the prednisone treatment group (2.4%) and 2 patients in the TAVNEOS group (1.2%) died. There were no deaths in the phase 2 trials. In the phase 3 trial, seven patients (4.2%) in the TAVNEOS treatment group and 2 patients (1.2%) in the prednisone treatment group discontinued treatment due to hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzymes abnormalities.

The most frequent adverse reaction that led to drug discontinuation reported by > 1 patient and more frequently reported in patients treated with TAVNEOS was hepatic function abnormal (1.8%). The most common adverse reactions that occurred in ≥ 5% of patients and higher in the TAVNEOS group as compared with the prednisone group are listed in Table 1. Table 1.

Adverse Reactions Reported in ≥ 5% of Patients and Higher in TAVNEOS Group vs. Prednisone Group in Phase 3 Trial Adverse Reaction Prednisone (N = 164) n (%) TAVNEOS (N = 166) n (%) N = number of patients randomized to treatment group in the Safety Population; n = number of patients in specified category. Nausea 34 (20.7) 39 (23.5) Headache 23 (14.0) 34 (20.5) Hypertension 29 (17.7) 30 (18.1) Diarrhea 24 (14.6) 25 (15.1) Vomiting 21 (12.8) 25 (15.1) Rash 13 (7.9) 19 (11.4) Fatigue 15 (9.1) 17 (10.2) Upper abdominal pain 10 (6.1) 11 (6.6) Dizziness 10 (6.1) 11 (6.6) Blood creatinine increased 8 (4.9) 10 (6.0) Paresthesia 7 (4.3) 9 (5.4) Hepatotoxicity and Elevated Liver Function Tests In the phase 3 trial, a total of 19 patients (11.6%) in the prednisone group and 22 patients (13.3%) in the TAVNEOS group had hepatic-related adverse reactions, including hepatobiliary adverse reactions and liver enzyme abnormalities.

Study medication was paused or discontinued permanently due to hepatic-related adverse reactions in 5 patients (3.0%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS group. Serious hepatic-related adverse reactions were reported in 6 patients (3.7%) in the prednisone group and 9 patients (5.4%) in the TAVNEOS grou…

🔄 Drug Interactions 204 words ▾

7 DRUG INTERACTIONS Strong and moderate CYP3A4 enzyme inducers: Avoid use. ( 7.1 ) Strong CYP3A4 enzyme inhibitors: Reduce avacopan dose to 30 mg once daily. ( 7.2 ) CYP3A4 substrates: Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS with CYP3A4 substrates. ( 7.3 )

7.1CYP3A4 Inducers Avacopan exposure is decreased when co-administered with strong CYP3A4 enzyme inducers such as rifampin [see Clinical Pharmacology (12.3) ] . Avoid co-administration of strong and moderate CYP3A4 inducers with TAVNEOS.

7.2CYP3A4 Inhibitors Avacopan exposure is increased when co-administered with strong CYP3A4 enzyme inhibitors such as itraconazole [see Clinical Pharmacology (12.3) ] . Administer TAVNEOS 30 mg once daily when co-administered with strong CYP3A4 inhibitors.

7.3CYP3A4 Substrates Avacopan is a moderate CYP3A4 inhibitor. Co-administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity).

Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS with CYP3A4 substrates. Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with TAVNEOS in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of avacopan to pregnant hamsters and rabbits during the period of organogenesis produced no evidence of fetal harm with exposures up to approximately 5 and 0.6 times, respectively, the exposure at the maximum recommended human dose (MRHD) of 30 mg twice daily (on an area under the curve [AUC] basis). Avacopan caused an increase in the number of abortions in rabbits at an exposure 0.6 times the MRHD (see Animal Data ) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study with pregnant hamsters dosed by the oral route during the period of organogenesis from gestation days 6 to 12, avacopan produced an increase in the incidence of a skeletal variation, described as supernumerary ribs, at an exposure that was 5 times the MRHD (on an AUC basis with a maternal oral dose of 1000 mg/kg/day).

No structural abnormalities were noted with exposures up to 5 times the MRHD (on an AUC basis with maternal oral doses up to 1000 mg/kg/day). In an embryo-fetal development study with pregnant rabbits dosed by the oral route during the period of organogenesis from gestation days 6 to 18, avacopan caused an increase in the number of abortions at an exposure 0.6 times the MRHD (on an AUC basis with a maternal oral dose of 200 mg/kg/day), however, no evidence of fetal harm was observed with such exposures. Maternal toxicity, as evidenced by decreased body weight gains, was observed at exposures 0.6 times and higher than the MRHD (on an AUC basis with maternal oral doses of 30 mg/kg/day and higher).

In a prenatal and postnatal development study with pregnant hamsters dosed by the oral route during the periods of gestation and lactation from gestation day 6 to lactation day 20, avacopan had no effects on the growth and development of offspring with exposures up to approximately 5 times the MRHD (on an AUC basis with maternal oral doses up to 1000 mg/kg/day).

8.2Lactation Risk Summary There are no available data on the effects of avacopan on the breast-fed child or on milk production. It is unknown whether avacopan is secreted in human milk. Avacopan was detected in the plasma of undosed hamster pups nursing from drug-treated dams (see Animal Data ) .

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TAVNEOS and any potential adverse effects on the breast-fed infant from TAVNEOS or from the underlying maternal condition. Animal Data Avacopan has not been measured in the milk of lactating animals; however, it was detected in the plasma of nursing offspring in a pre- and post-natal development study with hamsters at a pup to maternal plasma ratio of 0.37. This finding suggests that avacopan is secreted into the milk of lactating hamsters [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of TAVNEOS in pediatric patients have not been established.

8.5Geriatric Use Of the 86 geriatric patients who received TAVNEOS in the phase 3 randomized clinical trial for ANCA-associated vasculitis [see Clinical Studies (14) ] , 62 patients were between 65-74 years and 24 were 75 years or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients.

8.6Patients with Renal Impairment No dose adjustment is required for patients with mild, moderate, or severe renal impairment [see Clinical Pharmacology (12.3) ] . TAVNEOS has not been studied in patients with ANCA-associated vasculitis who are on dialysis.

8.7 Patients with…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with TAVNEOS in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of avacopan to pregnant hamsters and rabbits during the period of organogenesis produced no evidence of fetal harm with exposures up to approximately 5 and 0.6 times, respectively, the exposure at the maximum recommended human dose (MRHD) of 30 mg twice daily (on an area under the curve [AUC] basis). Avacopan caused an increase in the number of abortions in rabbits at an exposure 0.6 times the MRHD (see Animal Data ) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study with pregnant hamsters dosed by the oral route during the period of organogenesis from gestation days 6 to 12, avacopan produced an increase in the incidence of a skeletal variation, described as supernumerary ribs, at an exposure that was 5 times the MRHD (on an AUC basis with a maternal oral dose of 1000 mg/kg/day).

No structural abnormalities were noted with exposures up to 5 times the MRHD (on an AUC basis with maternal oral doses up to 1000 mg/kg/day). In an embryo-fetal development study with pregnant rabbits dosed by the oral route during the period of organogenesis from gestation days 6 to 18, avacopan caused an increase in the number of abortions at an exposure 0.6 times the MRHD (on an AUC basis with a maternal oral dose of 200 mg/kg/day), however, no evidence of fetal harm was observed with such exposures. Maternal toxicity, as evidenced by decreased body weight gains, was observed at exposures 0.6 times and higher than the MRHD (on an AUC basis with maternal oral doses of 30 mg/kg/day and higher).

In a prenatal and postnatal development study with pregnant hamsters dosed by the oral route during the periods of gestation and lactation from gestation day 6 to lactation day 20, avacopan had no effects on the growth and development of offspring with exposures up to approximately 5 times the MRHD (on an AUC basis with maternal oral doses up to 1000 mg/kg/day).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of TAVNEOS in pediatric patients have not been established.

🧓 Geriatric Use 55 words ▾

8.5Geriatric Use Of the 86 geriatric patients who received TAVNEOS in the phase 3 randomized clinical trial for ANCA-associated vasculitis [see Clinical Studies (14) ] , 62 patients were between 65-74 years and 24 were 75 years or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.

12.2Pharmacodynamics Avacopan blocks the C5a-induced upregulation of CD11b (integrin alpha M) on neutrophils taken from humans dosed with avacopan. The clinical significance of the pharmacodynamic effect is unclear. Cardiac Electrophysiology At the approved recommended dose, TAVNEOS does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Based on population pharmacokinetic analysis, the mean steady state plasma exposure estimates of avacopan are 3466 ± 1921 ng∙h/mL for the 12-hour area under the plasma drug concentration over time curve (AUC 0-12hr ) and 349 ± 169 ng/mL for the maximum plasma concentration (C max ) in patients with ANCA-associated vasculitis receiving 30 mg avacopan twice daily. Steady state plasma levels of avacopan are reached by 13 weeks and the accumulation is approximately 4-fold. Absorption Co-administration of 30 mg in capsule formulation with a high-fat, high-calorie meal increases AUC and C max of avacopan by approximately 72% and 8%, respectively, and delays t max by approximately 4 hours (from 2.0 hours to 6.0 hours).

Distribution The plasma protein binding (e.g., to albumin and α1-acid glycoprotein) of avacopan and metabolite M1 is greater than 99.9%. The apparent volume of distribution of avacopan is estimated to be 345 L. Elimination Based on population pharmacokinetic analysis, the estimated total apparent body clearance (CL/F) of avacopan is

16.3L/h. Following a single dose of 30 mg avacopan with food, the mean elimination half-lives of avacopan and M1 are 97.6 hours and 55.6 hours, respectively, in healthy subjects. Metabolism CYP3A4 is the major enzyme responsible for the clearance of avacopan and for the formation and clearance of the major circulating metabolite M1, a mono-hydroxylated product of avacopan.

M1 was present at ~12% of the total drug-related materials in plasma and has approximately the same activity as avacopan on the C5aR. Excretion The main route of clearance of avacopan is metabolism followed by biliary excretion of the metabolites into feces. Following oral administration of radiolabelled avacopan, about 77% and 10% of the radioactivity was recovered in feces and urine, respectively, and 7% and < 0.1% of the radioactive dose was recovered as unchanged avacopan in feces and urine, respectively.

Specific Populations No clinically significant differences in plasma exposure of avacopan and metabolite M1 were observed based on race (White, Asian, Black), gender (female 31%), age (18 to 83 years), body weight (40.3-174 kg), and renal function (eGFR 14-170 mL/min/1.73 m 2 at baseline). Patients with Hepatic Impairment Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment had no clinically relevant effect on avacopan and M1 plasma exposure. In subjects with mild or moderate hepatic impairment, avacopan AUC increased by 12% and 12%, respectively, C max decreased by 13% and 17%, respectively, compared to subjects with normal liver function.

In subjects with mild or moderate hepatic impairment, M1 AUC increased by 11% and 18%, respectively, C max decreased by 5% and 16%, respectively, compared to subjects with normal liver function. TAVNEOS has not been studied in subjects with severe hepatic impairment (Child-Pugh Class C). Drug Interaction Studies Effects of Other Drugs on TAVNEOS Avacopan is primarily metabolized by CYP3A4.

In vitro studies indicate that avacopan is not a substrate of BCRP and P-gp efflux, and OATP1B1 and OATP1B3 uptake transporters. M1 is a substrate of P-gp but is not a substrate of BCRP efflux, and OATP1B1 and OATP1B3 uptake tran…

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Avacopan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a. Avacopan blocks C5a-mediated neutrophil activation and migration. The precise mechanism by which avacopan exerts a therapeutic effect in patients with ANCA-associated vasculitis has not been definitively established.

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TAVNEOS (avacopan) capsule is supplied as a 10 mg, hard, opaque yellow and light orange capsule with "CCX168" printed in black. Bottle containing 180 capsules with child resistant induction seal closure (NDC 73556-168-01) Bottle containing 30 capsules with child resistant induction seal closure (NDC 73556-168-02) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Do not use if seal is broken or missing.

📦 Storage and Handling 32 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Do not use if seal is broken or missing.

📋 Description 163 words ▾

11 DESCRIPTION TAVNEOS (avacopan) capsules contain avacopan, a C5aR antagonist. Avacopan is a chiral molecule containing two stereocenters and has a chemical name of (2 R ,3 S )-2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)- N -[4-methyl-3-(trifluoromethyl)phenyl]piperidine-3-carboxamide. It has a molecular formula of C 33 H 35 F 4 N 3 O 2 and a molecular weight of 582 g/mol.

Avacopan has the following structural formula: Avacopan is a white to pale yellow crystalline solid that is soluble in organic solvents and practically insoluble in water. TAVNEOS is available as a 10 mg capsule for oral administration. The capsules include the following inactive ingredients: Polyethylene glycol 4000 (PEG-4000), Polyoxyl-40 hydrogenated castor oil.

The capsules are a light orange and yellow opaque bicolor gelatin capsule with a clear gelatin sealing band. The top half of the capsule is printed with "CCX168" in black ink. The capsule shell contains gelatin, red iron oxide, yellow iron oxide, and titanium dioxide, and the capsule sealing band contains gelatin and polysorbate 80.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA - approved patient labeling (Medication Guide). Dosage and Administration: Instruct the patient that TAVNEOS should be swallowed whole. TAVNEOS should not be chewed or crushed.

If a dose is missed, instruct the patient to take the next scheduled dose [see Dosage and Administration (2.2) ] . Hypersensitivity Reactions: Advise patients to seek immediate medical attention when experiencing any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, and difficulty in swallowing or breathing) and to discontinue the drug until they have consulted with the prescribing physician [see Warnings and Precautions (5.2) ] . Hepatotoxicity: Inform patients of the signs and symptoms of hepatic adverse reactions.

Advise patients to contact their healthcare provider immediately for signs or symptoms of liver problems; yellowing of the skin or the white part of the eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of the stomach area (abdomen), bleeding or bruising [see Warnings and Precautions (5.1) ] . Infections: Inform patients that serious infections have been reported in patients receiving TAVNEOS, including reactivation of hepatitis B infection. Instruct patients to contact their healthcare provider immediately if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.4) ] .

Lactation: Consider benefits/risk during lactation [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 05/2026 MEDICATION GUIDE TAVNEOS ® (tav' nee ose) (avacopan) capsules, for oral use What is the most important information I should know about TAVNEOS? TAVNEOS may cause serious side effects, including: Liver problems.

People taking TAVNEOS may have serious liver problems, including a type of liver injury called vanishing bile duct syndrome (VBDS) that causes the loss of bile ducts in the liver. VBDS is severe and can lead to death.VBDS has been reported predominantly in Japan in patients aged 65 years and older but can happen to anyone. Call your healthcare provider right away if you have unexplained symptoms such as: yellowing of your skin or the white part of your eyes (jaundice) itchy skin (pruritus) pain on the upper right side of your stomach area (abdomen) feeling tired dark or brown (tea colored) urine bleeding or bruising more easily than normal loss of appetite Your healthcare provider will do blood tests to check how well your liver is working before starting and during your treatment with TAVNEOS.

If you are of Japanese descent, your healthcare provider may recommend additional liver function testing and monitoring. What is TAVNEOS? TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)- associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener's granulomatosis, and microscopic polyangiitis [MPA]).

It is not known if TAVNEOS is safe and effective in children under the age of 18. Do not take TAVNEOS: if you are allergic to avacopan or any of the other ingredients in TAVNEOS. See the end of this Medication Guide for a complete list of the ingredients in TAVNEOS.

Get medical help right away if you experience swollen lips, tongue, throat, trouble swallowing, or difficulty breathing. These could be signs of an allergic reaction. Do not take more of TAVNEOS until you have consulted with your healthcare provider.

Before taking TAVNEOS, tell your healthcare provider about all your medical conditions including if you: have or have had abnormal liver blood tests. have or have had liver problems. have or think you may have hepatitis B or hepatitis C. have an infection. are pregnant or are planning to become pregnant. It is not known if TAVNEOS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.

It is not known if TAVNEOS can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TAVNEOS. Tell your healthcare provider about all the other medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TAVNEOS and certain other medicines may affect each other and cause side effects. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist. Some medicines should not be taken with TAVNEOS.

Your healthcare provider may prescribe other medicines to treat your disease. How should I take TAVNEOS? Take TAVNEOS exactly as your healthcare provider tells you to take it.

Do not stop taking TAVNEOS unless your healthcare provider tells you to. Check with your healthcare provider or pharmacist if you are not sure. Take 3 capsules of TAVNEOS 2 times daily (morning and evening) with food.

Your healthcare provider may tell you to take 3 capsules of TAVNEOS 1 time each day if you take certain medicines. Tell your healthcare provider about all the medicines you take. Swallow the capsules whole with water.

Do not crush, chew or open the capsules. If you miss a dose of TAVNEOS, do not take the missed dose. Just take the next dose at your regular time.

If you have taken too much TAVNEOS, call your doctor or a Poison Control Center, or go to the nearest hospital emergency room. Wh…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 73555-0502-00 · Syndax 73557-0130-05 · Shanghai →
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.