Avacopan
Avacopan (Tavneos) is a prescription capsule used alongside standard therapy to treat severe active ANCA-associated vasculitis — a serious autoimmune disease that inflames blood vessels — in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Avacopan: Patient Information Guide
A plain-language walkthrough of Avacopan — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Avacopan is approved for one indication across its supported product, Tavneos:
- Tavneos (oral capsule) is indicated as an adjunctive (add-on) treatment for adult patients with severe active ANCA-associated vasculitis — specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) — used in combination with standard therapy including glucocorticoids (steroids). Tavneos does not eliminate the need for glucocorticoid treatment.
⚙️How it works▾
Avacopan is a complement 5a receptor (C5aR) antagonist — meaning it blocks a specific docking site on immune cells. Normally, a protein fragment called C5a binds to C5aR on neutrophils (a type of white blood cell), activating them to migrate to and attack blood vessel walls. In ANCA-associated vasculitis, this process drives the dangerous inflammation that damages organs. By blocking C5aR, avacopan prevents C5a from triggering that immune attack. The exact way this translates into clinical benefit in ANCA-associated vasculitis has not been definitively established.
💊How it's taken▾
Tavneos is taken as oral capsules twice a day, with food — food substantially increases how much drug your body absorbs, so taking it with a meal is important, not optional. Capsules must be swallowed whole; crushing, chewing, or opening them is not recommended.
- If you miss a dose, skip it and take the next dose at your usual time — do not double up
- If you are also taking a strong CYP3A4 inhibitor medicine, your doctor will likely reduce Tavneos to once daily
- Strong and moderate CYP3A4 inducers should be avoided while taking Tavneos
Always follow your prescriber's specific instructions and the directions on your prescription label.
🤒Side effects — in detail▾
The most common side effects reported in clinical trials with Tavneos include:
- Nausea, vomiting, or diarrhea
- Upper abdominal pain
- Headache or dizziness
- High blood pressure (hypertension)
- Skin rash
- Fatigue
- Tingling or abnormal sensations (paresthesia)
- Elevated creatinine on blood tests (a marker of kidney function)
More serious reactions — including significant liver injury, serious infections like pneumonia, and angioedema (dangerous swelling of the face or airway) — have also been reported. Contact your doctor promptly or seek emergency care if any of these occur.
⚠️Warnings & precautions▾
- Liver injury (hepatotoxicity): Serious, life-threatening, and fatal liver damage has occurred, including a condition called vanishing bile duct syndrome (VBDS). Liver function must be tested before starting and monitored regularly — every 4 weeks for the first 6 months. Patients of Japanese descent may need testing every 2 weeks initially. Report jaundice, itching, or dark urine immediately.
- Angioedema (severe allergic swelling): Swelling of the face, lips, tongue, or throat has been reported. Stop Tavneos immediately and get emergency care. Do not restart unless a different cause has been confirmed.
- Hepatitis B reactivation: A previously controlled hepatitis B infection can suddenly become active again, causing severe hepatitis or liver failure. All patients must be screened for hepatitis B before starting Tavneos and monitored throughout and for 6 months after stopping.
- Serious infections: Fatal infections have occurred. Avoid Tavneos if you have a serious active infection. Report any signs of infection — fever, chills, cough, painful urination — promptly.
🔀What it interacts with▾
Avacopan is processed primarily by a liver enzyme called CYP3A4, and it also affects this enzyme — which means several medicines can interact with it:
- Strong or moderate CYP3A4 inducers (e.g., rifampin, used for TB or bacterial infections) — drastically reduce avacopan levels; avoid combining
- Strong CYP3A4 inhibitors (e.g., itraconazole, an antifungal) — significantly raise avacopan levels; your dose of Tavneos should be reduced to once daily if these are needed
- Simvastatin (a cholesterol-lowering statin) — Tavneos raises simvastatin blood levels, increasing the risk of muscle damage; your doctor may need to limit your simvastatin dose
- Other CYP3A4 substrates — Tavneos is a moderate CYP3A4 inhibitor and may raise blood levels of many other medicines; always inform your prescriber and pharmacist of everything you take
- Proton pump inhibitors (e.g., omeprazole) — not expected to have a meaningful effect on Tavneos levels
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Liver disease or cirrhosis: Tavneos is not recommended for people with active, uncontrolled chronic liver disease or cirrhosis, especially severe (Child-Pugh C) impairment. Liver function tests are required before starting.
- Hepatitis B history: All patients must be screened for hepatitis B (HBsAg and anti-HBc) before starting. Past or current hepatitis B requires specialist guidance and may need antiviral medicines.
- Active serious infection: Tavneos should be avoided if you currently have a serious active infection; wait until it is treated and controlled.
- History of tuberculosis or travel to TB/fungal-endemic regions: Discuss with your doctor before starting, as Tavneos may increase infection risk.
- Pregnancy: No adequate human studies exist. Animal data showed increased risk of miscarriage. Discuss risks and benefits with your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is unknown whether avacopan passes into human breast milk. Discuss with your doctor before breastfeeding.
- Children: Safety and effectiveness in pediatric patients have not been established; Tavneos is for adults only.
- Older adults (65+): No major differences in safety or effectiveness versus younger adults were observed, but patients of Japanese descent aged 65+ may be at higher risk for liver injury and may need more frequent monitoring.
- Kidney impairment: No dose adjustment is needed for mild, moderate, or severe kidney impairment. Tavneos has not been studied in patients on dialysis.
- Mild or moderate hepatic impairment: No dose adjustment is needed, but monitor closely for liver side effects.
📡Pharmacodynamics — effects in the body▾
Avacopan blocks the C5a-induced activation of neutrophils by occupying the complement 5a receptor (C5aR) on these immune cells. In studies of people dosed with avacopan, the drug reduced the C5a-triggered increase in a surface marker called CD11b on neutrophils — reflecting its effect on dampening immune cell activity. The clinical significance of this specific measurable effect is not fully established. At the approved recommended dose, Tavneos does not meaningfully affect the heart's electrical rhythm (does not prolong the QT interval).
🔬Pharmacokinetics — how your body processes it▾
When taken with food, avacopan is well absorbed — a high-fat meal significantly increases the amount that reaches the bloodstream, which is why taking it with food matters. It is extensively bound to blood proteins (more than 99.9%) and is mainly broken down by a liver enzyme called CYP3A4 into an active metabolite. The drug has a long half-life (roughly 4 days for avacopan itself in healthy subjects), and steady-state blood levels are reached by about 13 weeks of twice-daily dosing. Most of the drug and its metabolites leave the body through the feces via bile, with a small amount excreted in urine. Age, sex, race, body weight, and mild-to-moderate kidney or liver impairment do not meaningfully change how much drug is in the bloodstream.
📦How to store it▾
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) .
📄 Written from Avacopan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Avacopan
171 supplements and herbal products have documented interactions with Avacopan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 129
- Minor · 36
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Avacopan — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tavneos used for, and why do I still need to take steroids? ▾
Do I need to take Tavneos with food? Does it matter if I don't? ▾
What side effects should I expect, and which ones should I call the doctor about? ▾
I've heard Tavneos can cause liver problems. How worried should I be? ▾
I take other medicines. Are there any I need to be careful about mixing with Tavneos? ▾
Is Tavneos safe to take if I'm pregnant or thinking about becoming pregnant? ▾
Is Avacopan available over the counter? ▾
When was Avacopan first available? ▾
Who makes Avacopan? ▾
💬 Answers drafted from Avacopan’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Avacopan comes
Avacopan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Tavneos capsules are used to treat severe active ANCA-associated vasculitis (GPA and MPA) in adults, as an add-on to standard therapy including glucocorticoids
- Tavneos does not replace steroid treatment — it is used alongside it
- Tavneos capsules are taken twice daily with food — food meaningfully increases how much of the medicine your body absorbs
- Tavneos capsules must be swallowed whole; do not crush, chew, or open them
- If you miss a dose of Tavneos, skip it and take your next dose at the usual scheduled time — never take a double dose
- If you are also taking a strong CYP3A4 inhibitor (such as itraconazole), your doctor will adjust how often you take Tavneos
📊 Avacopan across the U.S. market
How Avacopan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Avacopan is used
A general measure of how commonly Avacopan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Avacopan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Avacopan prescribed? Of the 1,594 medications we measure, Avacopan ranks #1,216 by Medicaid prescriptions — more than 24% of them.
Utilization by Avacopan product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
avacopan 10 MG Oral Capsule
Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2572105
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Avacopan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 7 listed Avacopan NDCs with Medicaid activity.
🔍 Compare Avacopan products
A representative set of FDA-listed product records for Avacopan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 10 mg | Oral | ChemoCentryx, Inc. × 3 listings | NDA | View NDC → |
| 10 mg | — | Mw Encap Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg | — | Patheon Pharmaceuticals Inc. × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hovione LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Lonza AG | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Maithri Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 35 kg/35 kg | — | Nuray Chemicals Private Limited | BULK INGREDIENT | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Avacopan NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Avacopan — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Avacopan in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Avacopan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2572100 1 dose form · 1 strength
-
Dose form (SCDF) Oral Capsule RxCUI 2572104In current FDA listingsClinical drug / strength (SCD) 10 MGRxCUI 2572105
Look up RxCUI 2572100 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Avacopan is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Avacopan belongs to the Complement 5a Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. ChemoCentryx, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.