Tavneos: Uses, Dosage & Side Effects
A selective complement C5a receptor inhibitor for the treatment of ANCA-associated vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)
Tavneos (avacopan) is a first-in-class oral complement C5a receptor (C5aR1) inhibitor used to treat adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). These are serious autoimmune conditions that cause inflammation in small blood vessels, potentially leading to severe damage to the kidneys, lungs, sinuses, and other organs. Tavneos works by blocking the C5a receptor on immune cells, reducing the inflammatory response that drives vasculitis. It represents a major advance as a glucocorticoid-sparing treatment option, allowing patients to avoid or significantly reduce the substantial side effects associated with long-term corticosteroid therapy. Tavneos is used in combination with other immunosuppressive treatments and requires a prescription.
Quick Facts: Tavneos
Key Takeaways
- Tavneos (avacopan) is the first oral complement C5a receptor inhibitor approved for ANCA-associated vasculitis (GPA and MPA), offering a targeted approach to reduce blood vessel inflammation.
- In the landmark ADVOCATE trial, Tavneos demonstrated superior sustained remission at 52 weeks compared with a tapering glucocorticoid regimen, while also showing benefits in preserving kidney function.
- Tavneos enables a glucocorticoid-sparing treatment strategy, helping patients avoid the significant side effects of long-term corticosteroid use such as diabetes, osteoporosis, and infections.
- Regular liver function monitoring is essential during treatment, as hepatotoxicity including serious liver injury has been reported; the dose is 30 mg (three 10 mg capsules) taken twice daily with food.
- Tavneos should not be used in patients with active liver disease or active serious infections, and grapefruit must be avoided during treatment due to drug interaction potential.
What Is Tavneos and What Is It Used For?
Tavneos contains the active substance avacopan, which belongs to a new class of medications that target the complement system — a key part of the innate immune system. Specifically, avacopan binds to and blocks the complement 5a receptor (C5aR1, also known as CD88), a protein found on the surface of neutrophils, monocytes, and macrophages. This receptor normally responds to the complement fragment C5a, a powerful inflammatory mediator that attracts white blood cells and triggers their activation at sites of tissue damage.
In ANCA-associated vasculitis, the immune system produces abnormal antibodies called anti-neutrophil cytoplasmic antibodies (ANCA) that target proteins on the surface of neutrophils. When these antibodies activate neutrophils, the complement system becomes involved, generating C5a fragments that further amplify neutrophil recruitment and activation at the walls of small blood vessels. This creates a destructive inflammatory cycle that leads to vasculitis — inflammation and damage to small blood vessels throughout the body, most commonly affecting the kidneys, lungs, upper respiratory tract, sinuses, and nervous system.
By selectively blocking the C5a receptor, Tavneos interrupts this inflammatory amplification loop. It prevents C5a from triggering neutrophil chemotaxis (migration toward blood vessel walls), degranulation (release of tissue-damaging enzymes), and the generation of reactive oxygen species. Importantly, because avacopan specifically targets the C5aR1 receptor rather than depleting complement proteins broadly, it preserves other important functions of the complement system in host defense against infections.
Approved Indications
Tavneos is approved by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and regulatory authorities in Japan and other countries for the following indication:
- ANCA-associated vasculitis in adults: Tavneos is used in combination with a rituximab or cyclophosphamide treatment regimen for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). It is used as an adjunctive treatment alongside standard immunosuppressive induction therapy.
Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis, primarily affects the small blood vessels and tissues of the kidneys, lungs, throat, nose, and sinuses, although other organs can also be involved. Patients develop granulomas — small clusters of inflammatory cells — in and around blood vessels, which are caused by the inflammatory tissue damage. GPA is associated with antibodies against proteinase 3 (PR3-ANCA) in most cases.
Microscopic polyangiitis (MPA) affects the smaller blood vessels, often in the kidneys, but can also involve the lungs and other organs. Unlike GPA, MPA typically does not form granulomas but instead causes necrotizing vasculitis — direct damage and death of blood vessel wall cells. MPA is most commonly associated with antibodies against myeloperoxidase (MPO-ANCA). Both conditions can lead to rapidly progressive glomerulonephritis (kidney inflammation), pulmonary hemorrhage, and multi-organ failure if left untreated.
Tavneos was specifically developed to address one of the greatest unmet needs in vasculitis treatment: the substantial toxicity of long-term glucocorticoid (corticosteroid) therapy. Traditional treatment of ANCA-associated vasculitis requires months of high-dose glucocorticoids, which cause significant side effects including diabetes, osteoporosis, weight gain, cataracts, increased infection risk, and cardiovascular complications. The ADVOCATE trial demonstrated that Tavneos can replace the glucocorticoid component while maintaining equivalent or superior disease control, representing a paradigm shift in vasculitis management.
What Should You Know Before Taking Tavneos?
Contraindications
There are specific situations in which Tavneos must not be used. Understanding these contraindications is essential for safe treatment:
- Hypersensitivity: Do not take Tavneos if you are allergic to avacopan or any of the other ingredients in the capsules, including macrogolglycerol hydroxystearate, macrogol 4000, gelatin, polysorbate 80, iron oxides (E172), titanium dioxide (E171), shellac, or potassium hydroxide.
Tavneos is also not recommended for patients with:
- Active liver disease: Patients with active hepatic disease should not take Tavneos due to the risk of worsening liver injury. Hepatotoxicity including serious and potentially life-threatening hepatic injury and bile duct damage has been reported.
- Active serious infection: Tavneos should not be initiated in patients with an active serious infection, as the drug modulates immune function and may impair the body's ability to fight severe infections.
Warnings and Precautions
Serious liver damage and bile duct injury have been reported in patients taking Tavneos. Symptoms may include nausea, vomiting, fatigue, loss of appetite, yellowing of the skin or eyes (jaundice), dark urine, itching, or upper abdominal pain. Your doctor will perform blood tests to monitor liver enzymes and bilirubin levels before and during treatment. Contact your healthcare provider immediately if you develop any of these symptoms.
Before and during treatment with Tavneos, inform your doctor if any of the following conditions apply to you:
- Signs of liver damage: Including nausea, vomiting, fatigue, loss of appetite, yellowing of skin or eyes, dark urine, itching, upper abdominal pain, or elevated bilirubin or liver enzyme levels in blood tests.
- Infections: Including any current infection, unexpected bruising and bleeding (which may indicate bone marrow suppression), hepatitis B, hepatitis C, HIV infection, or tuberculosis.
- Heart disease: Such as a history of heart attack, heart failure, or inflammation of the heart's blood vessels.
- Cancer: Any type of current or recent malignancy.
Your doctor will regularly perform blood tests during treatment to monitor:
- Liver function: By measuring liver enzymes (transaminases) and total bilirubin levels. Treatment may be temporarily paused or permanently discontinued if significant liver abnormalities develop.
- Infection risk: By monitoring white blood cell counts, particularly neutrophils. Low white blood cell counts may increase vulnerability to infections.
Your doctor will also monitor you for signs and symptoms of Neisseria meningitidis infection (meningococcal disease), which is recommended for adults with GPA or MPA receiving complement-targeting therapies. It is also recommended that you receive vaccination against Pneumocystis jirovecii pneumonia and that vaccinations be completed before starting Tavneos, ideally during a disease-free period.
Severe and usually painful swelling under the skin, particularly of the face, has been reported during treatment with Tavneos. If this affects the throat, it may cause breathing difficulties. Stop taking Tavneos and seek emergency medical attention immediately if you experience swelling of the face, lips, tongue, or throat, or if you have difficulty breathing.
Pregnancy and Breastfeeding
Tavneos is not recommended during pregnancy or for women of childbearing potential who are not using effective contraception. The effects of avacopan on human pregnancy have not been adequately studied, and the potential risk to the developing fetus is unknown. If you become pregnant while taking Tavneos, contact your doctor immediately to discuss your treatment options.
It is not known whether avacopan passes into breast milk in humans. A risk to the nursing infant cannot be excluded. Your doctor will help you decide whether to discontinue Tavneos or to stop breastfeeding, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.
Children and Adolescents
Tavneos should not be given to children and adolescents under 18 years of age. There is insufficient evidence to establish the safety and efficacy of avacopan in the pediatric population. Clinical trials for ANCA-associated vasculitis have been conducted exclusively in adult patients.
Driving and Using Machines
Tavneos is not expected to affect your ability to drive or use machines. However, if you experience any side effects that could impair your alertness or coordination, you should avoid driving or operating machinery until the effects resolve.
How Does Tavneos Interact with Other Drugs?
Avacopan is primarily metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system in the liver. This means that drugs which strongly induce or inhibit CYP3A4 can significantly affect Tavneos blood levels. Additionally, avacopan itself can affect the metabolism of other drugs. It is critical to inform your doctor about all medications you are taking, including over-the-counter drugs and herbal products.
Major Interactions — Drugs That Reduce Tavneos Effectiveness
The following drugs are strong CYP3A4 inducers and can significantly reduce avacopan plasma concentrations, potentially making Tavneos less effective. These combinations should be avoided unless short-term use is unavoidable and your doctor monitors your condition closely:
| Drug | Used For | Interaction Type |
|---|---|---|
| Carbamazepine | Epilepsy, bipolar disorder | Strong CYP3A4 inducer — reduces avacopan levels |
| Phenobarbital | Epilepsy, seizure disorders | Strong CYP3A4 inducer — reduces avacopan levels |
| Phenytoin | Epilepsy, seizure disorders | Strong CYP3A4 inducer — reduces avacopan levels |
| Rifampicin | Tuberculosis, certain infections | Strong CYP3A4 inducer — reduces avacopan levels |
| St. John's Wort | Mild depression (herbal) | Strong CYP3A4 inducer — reduces avacopan levels |
| Enzalutamide | Prostate cancer | Strong CYP3A4 inducer — reduces avacopan levels |
| Mitotan | Adrenal cancer | Strong CYP3A4 inducer — reduces avacopan levels |
Other Important Interactions
Tavneos can also affect or be affected by many other medications. The following drugs require careful monitoring or dose adjustments when used concurrently:
| Drug | Used For | Nature of Interaction |
|---|---|---|
| Itraconazole, Posaconazole, Voriconazole, Ketoconazole | Fungal infections / Cushing's syndrome | Strong CYP3A4 inhibitors — may increase avacopan levels |
| Clarithromycin, Telithromycin | Bacterial infections | Strong CYP3A4 inhibitors — may increase avacopan levels |
| Ciclosporin, Sirolimus, Tacrolimus | Immunosuppression, transplant rejection | Mutual interaction — levels of both drugs may change |
| Simvastatin | High cholesterol | Avacopan may increase simvastatin levels |
| Dabigatran | Blood clot prevention | Avacopan may affect dabigatran levels |
| Ritonavir, Lopinavir/Ritonavir, Indinavir, Saquinavir, Nelfinavir | HIV infection | Strong CYP3A4 inhibitors — may increase avacopan levels |
| Bosentan | Pulmonary arterial hypertension | Moderate CYP3A4 inducer — may reduce avacopan levels |
| Alfentanil, Fentanyl | Pain management / anesthesia | Avacopan may affect opioid metabolism |
| Dihydroergotamine, Ergotamine | Migraine | Avacopan may affect ergot alkaloid levels |
| Modafinil | Excessive sleepiness | Moderate CYP3A4 inducer — may reduce avacopan levels |
Avoid grapefruit and grapefruit juice during treatment with Tavneos. Grapefruit is a known inhibitor of CYP3A4 and can increase avacopan blood levels, potentially leading to an increased risk of side effects. This includes all grapefruit-containing products such as fresh fruit, juice, marmalade, and extracts.
What Is the Correct Dosage of Tavneos?
Always take Tavneos exactly as your doctor or pharmacist has instructed. Do not change your dose or stop taking Tavneos without consulting your healthcare provider. Tavneos is intended for use under the supervision of a physician experienced in the diagnosis and treatment of ANCA-associated vasculitis.
Adults
Standard Adult Dose
30 mg twice daily (three 10 mg hard capsules in the morning and three 10 mg hard capsules in the evening). The total daily dose is 60 mg (six capsules per day).
- Take with a meal to improve absorption
- Swallow capsules whole with a glass of water
- Do not crush, chew, or open the capsules
- Take at approximately the same times each day
The duration of treatment is determined by your doctor based on your disease activity and response to therapy. Tavneos is used as part of a combination treatment regimen that typically includes rituximab or cyclophosphamide for induction of remission, and the treatment duration should be aligned with the overall management plan for your vasculitis.
Children
Pediatric Use
Tavneos is not approved for use in children and adolescents under 18 years of age. There is insufficient clinical data to establish safety and efficacy in this population.
Elderly Patients
Elderly Dose
No dose adjustment is required for elderly patients. However, older patients may be at increased risk of infections and liver effects, so careful monitoring is especially important in this population.
Renal and Hepatic Impairment
Dose Adjustments for Organ Impairment
No dose adjustment is required for patients with mild to moderate renal impairment. Tavneos has not been studied in patients with severe renal impairment or end-stage kidney disease on dialysis. Tavneos should not be used in patients with active liver disease, and caution is advised in patients with pre-existing hepatic impairment.
Missed Dose
If you miss a dose and there are more than 3 hours until your next scheduled dose, take the missed dose as soon as possible and then take the next dose at the regular time. If there are less than 3 hours until your next scheduled dose, skip the missed dose and take only the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Overdose
If you take more Tavneos than prescribed, contact your doctor immediately. There is limited experience with overdose of avacopan. Treatment of an overdose should consist of general supportive measures, including monitoring of vital signs and observation of clinical status. There is no specific antidote for avacopan.
If you develop severe swelling of the face, lips, tongue, or throat, or difficulty breathing, stop taking Tavneos and seek emergency medical attention immediately. In all other situations, do not stop taking Tavneos without first consulting your doctor. Abrupt discontinuation may lead to a flare of your vasculitis.
What Are the Side Effects of Tavneos?
Like all medicines, Tavneos can cause side effects, although not everybody experiences them. Some side effects can be serious and require immediate medical attention. Contact your doctor immediately if you experience any signs of liver problems (jaundice, dark urine, persistent nausea), severe allergic reactions with swelling, or signs of serious infection such as persistent fever, severe cough, or difficulty breathing.
Serious Side Effects Requiring Immediate Attention
Very Common
May affect more than 1 in 10 people
- Elevated liver enzymes (transaminases) — sign of liver stress
- Elevated bilirubin levels — yellow breakdown product of blood pigment
Common
May affect up to 1 in 10 people
- Pneumonia — symptoms may include wheezing, difficulty breathing, or chest pain
Uncommon
May affect up to 1 in 100 people
- Angioedema — severe allergic reactions causing swelling under the skin, particularly in the face, which may cause breathing difficulties
Not Known
Frequency cannot be estimated from available data
- Serious liver damage and bile duct injury — symptoms may include jaundice, dark urine, nausea, vomiting, fatigue, loss of appetite, itching, or upper abdominal pain
Other Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infections
- Sore throat and inflammation of the throat and nose (nasopharyngitis)
- Headache
- Nausea
- Diarrhea
- Vomiting
- Decreased white blood cell counts (leukopenia)
Common
May affect up to 1 in 10 people
- Inflammation inside the nose causing sneezing, itching, runny, and blocked nose (rhinitis)
- Urinary tract infection
- Sinusitis or bronchitis
- Inflammation of the stomach and intestinal lining (gastroenteritis)
- Lower respiratory tract infection
- Cellulitis (infection of the skin and underlying tissue)
- Shingles (herpes zoster)
- Influenza
- Candida or herpes infections of the mouth (oral thrush/cold sores)
- Middle ear infection (otitis media)
- Neutropenia (low neutrophil counts) — symptoms may include infections, fever, or pain when swallowing
- Upper abdominal pain
- Elevated creatine phosphokinase in blood — symptoms may include chest pain, confusion, muscle pain, sudden weakness, or numbness
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority. By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Tavneos?
Proper storage of Tavneos ensures the medication remains effective and safe throughout its shelf life. The following storage conditions should be observed:
- Temperature: No special temperature storage conditions are required. Store at room temperature.
- Light protection: Store in the original container to protect from light. Avacopan is sensitive to light degradation.
- Keep out of reach: Store out of the sight and reach of children.
- Expiry date: Do not use Tavneos after the expiry date stated on the carton or container after "EXP". The expiry date refers to the last day of the stated month.
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
What Does Tavneos Contain?
Active Ingredient
Each hard capsule contains 10 mg of avacopan as the active substance. Avacopan is a selective, orally administered small-molecule antagonist of the C5a receptor (C5aR1).
Inactive Ingredients (Excipients)
The other ingredients in Tavneos capsules are:
- Macrogolglycerol hydroxystearate (may cause stomach upset and diarrhea)
- Macrogol 4000
- Gelatin
- Polysorbate 80
- Red iron oxide (E172)
- Yellow iron oxide (E172)
- Black iron oxide (E172)
- Titanium dioxide (E171)
- Shellac
- Potassium hydroxide
Appearance and Pack Sizes
Tavneos hard capsules consist of a yellow body and light orange cap, marked with "CCX168" in black ink. Each capsule is 22 mm long with a diameter of 8 mm. The capsules are packaged in plastic bottles with child-resistant closures.
Tavneos is available in the following pack sizes:
- Packs containing 30 hard capsules
- Packs containing 180 hard capsules
- Multipacks containing 540 hard capsules (3 individual packs of 180 hard capsules)
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder
Vifor Fresenius Medical Care Renal Pharma France (now part of CSL Vifor), 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France. For additional information about Tavneos, please visit the European Medicines Agency website at www.ema.europa.eu or the FDA drug database.
Frequently Asked Questions About Tavneos
Tavneos (avacopan) is used to treat adults with ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). These are autoimmune diseases that cause inflammation of small blood vessels, potentially damaging the kidneys, lungs, and other organs. Tavneos is used in combination with other immunosuppressive treatments such as rituximab or cyclophosphamide.
Traditional treatment of ANCA-associated vasculitis relies heavily on high-dose glucocorticoids (corticosteroids) combined with immunosuppressive drugs. Tavneos works by specifically blocking the complement C5a receptor on immune cells, targeting a key driver of vasculitis inflammation. This targeted approach allows it to replace the glucocorticoid component of treatment, helping patients avoid the significant side effects of long-term steroid use such as diabetes, osteoporosis, weight gain, and increased infection risk.
The most common side effects include elevated liver enzymes and bilirubin levels (seen in blood tests), upper respiratory tract infections, sore throat, headache, nausea, diarrhea, vomiting, and reduced white blood cell counts. Regular blood tests are essential to monitor liver function. Serious but less common side effects include liver damage, pneumonia, and angioedema (severe swelling). Contact your doctor immediately if you develop jaundice, dark urine, or severe swelling.
In the ADVOCATE trial, Tavneos demonstrated that it can effectively replace a tapering glucocorticoid regimen when used alongside standard immunosuppressive therapy (rituximab or cyclophosphamide). Patients in the Tavneos group achieved non-inferior remission at week 26 and significantly superior sustained remission at week 52, with additional benefits for kidney function preservation. However, your doctor will determine the exact treatment plan based on your individual disease severity and clinical needs.
Grapefruit and grapefruit juice contain compounds (furanocoumarins) that inhibit the CYP3A4 enzyme, which is responsible for metabolizing avacopan in the liver. When CYP3A4 is inhibited, the breakdown of avacopan is slowed, leading to higher-than-intended drug levels in your bloodstream. This can increase the risk and severity of side effects. You should avoid grapefruit in all forms — fresh fruit, juice, and grapefruit-containing products — throughout your treatment with Tavneos.
Tavneos is not recommended during pregnancy or for women of childbearing potential who are not using effective contraception. There is insufficient human data to assess the safety of avacopan during pregnancy, and the potential risk to the fetus is unknown. It is also unknown whether avacopan passes into breast milk. If you are pregnant, planning to become pregnant, or breastfeeding, discuss your treatment options with your doctor.
References
- European Medicines Agency (EMA). Tavneos (avacopan) — Summary of Product Characteristics. Last updated 2025. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Tavneos (avacopan) Prescribing Information. Revised 2024.
- Jayne DRW, Merkel PA, Schall TJ, Bekker P. Avacopan for the Treatment of ANCA-Associated Vasculitis. New England Journal of Medicine. 2021;384(7):599–609. doi: 10.1056/NEJMoa2023386
- Merkel PA, Jayne DR, Wang C, et al. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Research Protocols. 2020;9(4):e16664.
- Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis & Rheumatology. 2021;73(8):1366–1383.
- Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney International. 2021;100(4S):S1–S276.
- Yates M, Watts RA, Bajema IM, et al. EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis. Annals of the Rheumatic Diseases. 2016;75(9):1583–1594.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a group of licensed healthcare professionals committed to providing accurate, evidence-based medical information.
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