Tavneos

Tavneos (avacopan) is a prescription medicine used to treat types of ANCA-associated vasculitis (anti-neutrophil cytoplasmic autoantibody-associated vasculitis), including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Tavneos capsules are designed to help patients achieve remission and lower the risk of relapse by regulating the overactive immune system, which in turn reduces blood vessel inflammation.

Tavneos works by targeting and blocking the C5a receptor, a key part of the immune system that drives inflammation. This helps calm the immune response, easing symptoms and protecting blood vessels from damage. Tavneos is a C5a receptor antagonist (C5aR antagonist).

Tavneos is typically prescribed in combination with standard treatments such as glucocorticoids.

Tavneos was developed by ChemoCentryx, a biopharmaceutical company specializing in oral medications for autoimmune diseases, inflammatory disorders, and cancers. ChemoCentryx was acquired by Amgen, a leading independent biotechnology company, on October 20, 2022.

Tavneos' FDA approval is for the treatment of severe active ANCA-associated vasculitis conditions, granulomatosis with polyangiitis [GPA], and microscopic polyangiitis [MPA] in adults. It is used in combination with standard therapy. Tavneos' FDA approval was granted on 7 October 2021, after positive results from the Phase III ADVOCATE trial (NCT02994927), published in The New England Journal of Medicine (NEJM).

On 27 April 2026, the FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawing Tavneos' approval. CDER has raised new safety concerns, including cases of serious drug-induced liver injury and vanishing bile duct syndrome, some of them fatal. Tavneos remains on the market while this is resolved through a hearing process (docket FDA-2026-N-1321), and the FDA advises patients to discuss Tavneos and other treatment options with their healthcare provider.

Tavneos' mechanism of action is as a C5a receptor (C5aR) antagonist that blocks the activity of complement 5a, a key mediator of inflammation within the complement cascade. In ANCA-associated vasculitis, excessive activation of the complement system can cause the immune system to mistakenly attack and damage blood vessel walls. By inhibiting the C5a receptor, Tavneos helps regulate this overactive immune response, reducing vascular inflammation, alleviating symptoms, and helping prevent further vessel damage.

ANCA-associated vasculitis is a rare autoimmune disease that causes inflammation and damage to small or medium-sized blood vessels, affecting organs like the kidneys, lungs, and respiratory tract. The two most common types of ANCA-associated vasculitis are:

• Granulomatosis with Polyangiitis (GPA): Mainly affects the respiratory tract and kidneys, leading to sinusitis, nosebleeds, and kidney disease. GPA was previously known as Wegener’s granulomatosis.
• Microscopic Polyangiitis (MPA): Primarily affects the kidneys and lungs, with less frequent upper respiratory tract involvement.

Anti-neutrophil cytoplasmic autoantibody-associated vasculitis is often shortened to ANCA-associated vasculitis.

Liver Toxicity Risk: Tavneos may cause serious side effects, including liver problems such as vanishing bile duct syndrome (VBDS), which causes the loss of bile ducts in the liver and can lead to death. Your doctor will perform liver function tests before and during treatment. Call your doctor immediately if you experience symptoms of liver problems, including yellowing of the skin or the white part of the eyes (jaundice), itchy skin, dark or brown (tea colored) urine, pain in the upper right side of the stomach area (abdomen), feeling tired, loss of appetite, or bleeding or bruising more easily than normal.

Hypersensitivity Reactions: This medicine may cause a serious hypersensitivity reaction called angiodema (swelling of the face, extremities, eyes, lips, tongue, and difficulty in swallowing or breathing). Seek immediate medical attention when experiencing any signs or symptoms suggesting angioedema, and to discontinue the drug until you have consulted with the prescribing physician

Hepatitis B Virus (HBV) Reactivation: If you have had hepatitis B or are a carrier of the virus, taking Tavneos could cause the virus to become an active infection again. Your doctor will do blood tests to check for HBV before you start. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes.

Infections: Serious infections can happen in people taking Tavneos, and these infections can lead to death. Patients should contact their healthcare provider immediately if they develop any signs or symptoms of an infection, such as fever, cold or flu symptoms, earache, headache, pain during urination, cold sores, or red, warm, swollen, or painful cuts. Tavneos should not be used in patients with active, serious infection.

Do not use Tavneos if you are allergic to the active ingredient avacopan or any inactive ingredients. Inform your doctor if you have:

• Liver problems or abnormal liver function tests
• Hepatitis B or C
• Active infections.

Pregnancy and Breastfeeding

• Pregnancy: It is unknown if Tavneos may harm an unborn baby. Talk to your doctor if you are pregnant or planning pregnancy.
• Breastfeeding: It is not known if Tavneos passes into breast milk. Discuss the best feeding options with your doctor.

Common Tavneos Side Effects

Common Tavneos side effects include:

• Nausea 39%
• Headache 34%
• High blood pressure 30%
• Diarrhea 25%
• Vomiting 25%
• Rash 19%
• Tiredness 17%
• Stomach pain 11%
• Dizziness 11%
• Increase blood creatinine levels 10%
• pins and needles (tingling or numbness) 9%.

These are the common side effects that occurred in 5% or more of patients in the Phase 3 clinical trial (NCT02994927) who received Tavneos 30 mg avacopan twice daily for 52 weeks.

Serious Side Effects

Tavneos may cause serious side effects. Seek immediate medical attention if you have:

• Allergic reactions: Hives, difficulty breathing, swelling of face, lips, tongue, or throat.
• Liver problems: Including a severe condition called vanishing bile duct syndrome (VBDS). Symptoms include yellowing of your skin or the white part of your eyes (jaundice), itchy skin, pain on the upper right side of your stomach area, feeling tired, dark or brown (tea colored) urine, bleeding or bruising more easily than normal, and loss of appetite.
• Severe infections: Fever, flu-like symptoms, painful urination, cold sores in the mouth or throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Recommended dose: 30 mg (three 10 mg capsules) twice daily with food.
• Administration: Swallow capsules whole with water. Do not crush, chew, break, or open the capsules.
• Important: Continue taking Tavneos as prescribed by your healthcare provider. Do not stop treatment without consulting your doctor.
• Dose modification: Reduce the Tavneos dose to 30 mg once daily when used together with medications that are strong CYP3A4 inhibitors.

Missed Dose: Skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

Overdose: Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Inform your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take.
• Some medicines should not be taken with Tavneos (avacopan)
• Keep a list of all the medicines that you take, and show it to your healthcare provider and pharmacist.
• Your healthcare provider may prescribe other medicines to treat your disease.

Strong and moderate CYP3A4 enzyme inducers: Avoid use.

Strong CYP3A4 enzyme inhibitors: Reduce avacopan dose to 30 mg once daily.

CYP3A4 substrates: Consider dose reduction of CYP3A4 substrates when co-administering Tavneos with CYP3A4 substrates.

Not all possible drug interactions are listed here.

The Tavneos Package Insert (PI) provides detailed prescribing information for healthcare professionals (HCPs) and patients. It includes comprehensive data on indications, dosage, administration guidelines, clinical pharmacology, drug interactions, and safety warnings.

The Tavneos PI, also referred to as the Tavneos Prescribing Information or FDA label, is an essential resource for understanding the full scope of this medication’s use. While it offers extensive details, it does not replace medical advice. Patients should consult their healthcare provider for personalized guidance on Tavneos treatment.

• Store at room temperature (68°F to 77°F or 20°C to 25°C).
• Keep out of reach of children and pets.

Active ingredient: avacopanInactive ingredients: polyethylene glycol 4000 (PEG-4000), Polyoxyl-40 hydrogenated castor oil.

Tavneos ChemoCentryx, Inc.

Tavneos Amgen (acquired ChemoCentryx in October 2022)

One Amgen Center Drive, Thousand Oaks, CA 91320-1799