Pronunciation: tav' nee ose
Generic name: avacopan
Dosage form: capsules (10mg)
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 17, 2024.

What is Tavneos?

Tavneos (avacopan) capsules are used to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), two forms of ANCA-associated vasculitis. Tavneos is used as an add-on treatment with other medicines for adults with active and severe symptoms.

Tavneos works by blocking a receptor in the blood called complement 5a (or C5a), which is part of the immune system. When Tavneos blocks the C5a receptor it may help reduce blood vessel inflammation, improving disease symptoms.  Tavneos is called a complement 5a receptor (C5aR) antagonist.

Tavneos FDA approval was received on October 7, 2021, as a treatment for adults with severe active (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) when used together with standard therapy including glucocorticoids.

 What is ANCA-associated vasculitis?

Anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis) is a rare autoimmune disease that causes inflammation and damage to small or medium-sized blood vessels, affecting various organs, including airways, kidneys, and lungs. Two forms of ANCA-associated vasculitis are granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) 

Granulomatosis with polyangiitis (GPA), previously called Wegener’s granulomatosis, mainly affects the respiratory tract and the kidneys, leading to sinusitis, nosebleeds, and kidney disease.

Microscopic polyangiitis (MPA) mainly affects the kidneys and lungs and, compared to GPA, less often involves the upper respiratory tract.

Tavneos side effects

Common Tavneos side effects may include tiredness, nausea, diarrhea, vomiting, stomach pain, rash, headache, dizziness, severe headache, blurred vision, pounding in your neck or ears, burning or prickling sensation, and an increase in blood creatinine.

Serious Tavneos side effects

Get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat. Do not take Tavneos if you are allergic to the active ingredient avacopan or any inactive ingredients.

Avacopan may cause other serious side effects. Call your doctor at once if you have:

• signs of liver problems - loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes); or
• signs of serious infections - fever, cold symptoms (runny nose or sore throat), flu symptoms (cough, tiredness, and body aches), earache or headache, painful urination, cold sores in mouth or throat.

Also, see the Warning section.

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.

Warnings

Tavneos may cause serious side effects, including liver problems. Call your doctor at once if you have loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes).

Your healthcare provider will do blood tests to check your liver is working before starting and during your treatment with this medicine.

Before taking Tavneos

You should not use this medicine if you are allergic to the active ingredient avacopan or any inactive ingredients. Tell your doctor if you have ever had:

• liver problems or abnormal liver function tests;
• hepatitis B or C; or
• if you currently have an infection.

Pregnancy

Talk to your healthcare provider if you are pregnant, are planning a pregnancy, or become pregnant as it is not known if Tavneos will harm your unborn baby. 

Breastfeeding 

Talk to your healthcare provider if you 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.

How should I take Tavneos?

Take Tavneos capsules twice a day (morning and evening) with food.

Swallow the capsule whole with water. Do not crush, chew, break, or open the capsules.

Take Tavneos exactly as your healthcare provider tells you how to take it. Do not stop treatment unless your healthcare provider tells you to. Check with your healthcare provider or pharmacist if you are not sure how to take this medicine.

Dosing information

Usual Adult Tavneos Dose for ANCA-Associated Vasculitis is 30 mg (three 10 mg capsules) twice daily, with food.

Use: 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.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

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

What other drugs will affect 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.

Tavneos Package Insert 

Review the Tavneos Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

How should I store Tavneos?

Store Tavneos capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of reach of children and pets.

What are the ingredients in Tavneos?

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

Company 

Manufactured for ChemoCentryx, Inc. by: Thermo Fisher Scientific, 2110 East Galbraith Road, Cincinnati, OH 45237 USA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer