TM Owner ChemoCentryx, Inc. (an Amgen company)
Tavneos 10mg Capsule
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Indications & Clinical Uses
- Tavneos 10 mg capsules contain avacopan, a complement C5a receptor inhibitor used as add-on treatment for adults with severe active ANCA-associated vasculitis - granulomatosis with polyangiitis and microscopic polyangiitis - given together with standard therapy including glucocorticoids, not as a stand-alone treatment.
- It helps control disease activity while allowing a faster taper of high-dose steroids.
- Tavneos was authorised in the European Union, but the European Commission revoked that marketing authorisation across the EU and European Economic Area on 6 August 2026 after a data-handling review of the pivotal ADVOCATE trial found the benefit-risk balance could no longer be confirmed; it remains an FDA-approved, prescription-only treatment in the United States, taken as capsules by mouth twice daily with food, under specialist supervision.
Side Effects
- Tavneos carries a boxed warning for hepatotoxicity: serious liver injury, including a rare but serious bile-duct disorder called vanishing bile duct syndrome, has occurred, so liver blood tests are required before starting and periodically during treatment, with the medicine stopped if levels rise too high.
- The most common side effects, each affecting more than one in ten patients, are nausea, headache, high blood pressure, diarrhoea, vomiting, rash, and fatigue.
- Serious hypersensitivity reactions including angioedema can occur and require immediate discontinuation.
- Report yellowing of the skin or eyes, dark urine, unusual tiredness, swelling of the face or throat, or signs of infection to your healthcare provider straight away.
Precautions & Warnings
- Liver function must be checked before starting Tavneos and monitored regularly during treatment because of the boxed hepatotoxicity warning; avoid use in anyone with active liver disease.
- Screening for hepatitis B is recommended before treatment, with monitoring for reactivation during and for six months afterward.
- Because avacopan can weaken the immune response to infection, it should not be started in patients with a serious active infection, and any new infection should be reported promptly.
- Tavneos has not been well studied in pregnancy; discuss contraception with your healthcare provider before use.
- No dose adjustment is defined for severe hepatic impairment, and it should be avoided in that setting.
- Capsules should be taken with food, and treatment should always continue alongside the standard glucocorticoid regimen your specialist prescribes.
Avoid Interactions
- Avacopan is broken down mainly by the CYP3A4 liver enzyme, so strong CYP3A4 inhibitors such as itraconazole, ketoconazole, clarithromycin, or ritonavir raise its levels; if one must be used together with Tavneos, the dose is reduced to 30 mg once daily.
- Strong and moderate CYP3A4 inducers, including rifampin, carbamazepine, phenytoin, and St John's wort, lower avacopan levels and should be avoided.
- Tavneos may also increase levels of other CYP3A4 substrate medicines, so dose adjustment of those may be needed.
- Tell your healthcare provider and pharmacist about every prescription and over-the-counter medicine, herbal product, and supplement you use, particularly antifungals, certain antibiotics, anticonvulsants, and HIV medicines, before starting or while taking Tavneos.
References
Frequently Asked Questions
Tavneos (avacopan) is an add-on treatment for adults with severe active ANCA-associated vasculitis - granulomatosis with polyangiitis or microscopic polyangiitis - used together with standard therapy including steroids, not alone. It was authorised in the EU, but that authorisation was revoked in August 2026; it remains FDA-approved in the US.
Tavneos capsules are taken by mouth, usually three 10 mg capsules (30 mg) twice daily with food, alongside your prescribed glucocorticoid taper. Take it at roughly the same times each day, and don't stop without talking to your specialist, even if you feel well.
Tavneos carries a boxed warning for liver injury (hepatotoxicity), including a rare bile-duct condition, so liver blood tests are required before and during treatment. Common side effects include nausea, headache, high blood pressure, diarrhoea, and fatigue. Report yellowing skin or eyes, dark urine, or facial swelling urgently.
Avoid strong CYP3A4 inhibitors such as ketoconazole and itraconazole unless your dose is reduced to 30 mg once daily, and avoid inducers like rifampin and St John's wort, which lower avacopan levels. Tell your provider about every medicine, herbal product, and supplement you take.
Tavneos requires liver function tests before starting and periodically during treatment because of its hepatotoxicity warning, plus hepatitis B screening beforehand. Your specialist also monitors blood pressure, infection risk, and vasculitis activity so your glucocorticoid dose can be tapered down safely over time.
The European Commission revoked Tavneos's EU marketing authorisation on 6 August 2026 after a review found data-handling issues in the pivotal ADVOCATE trial, meaning a positive benefit-risk balance could no longer be confirmed for the EU market. It remains approved and available in the United States.
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