About this disease state

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What is
ANCA‑associated
vasculitis?

Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis is a group of rare diseases involving inflammationThe body's reaction to injury or infection. It is characterized by swelling, heat, redness, and pain. of your small to medium-sized blood vessels. This inflammation reduces blood flow, which can result in damage to your organs. While your genetics and environment are probable factors that cause the disease, the exact cause isn’t known yet.

The two most common types of ANCA-associated vasculitis are GPA (granulomatosis with polyangiitis, previously called Wegener’s granulomatosis) and MPA (microscopic polyangiitis).

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What you need to know about GPA

In GPA, affected tissues can develop granulomasA mass of immune cells formed in response to persistent inflammation. , or small areas of inflammation. Signs of GPA usually start in the nose, ears, eyes, or mouth, but it can also affect the lungs and kidneys. If you have GPA, you may experience serious complications, such as hearing loss, kidney damage, skin scarring, or blood clots if your condition is not managed.

What you need to know about MPA

MPA also affects the lungs and kidneys, but unlike GPA, the ears, nose, and throat are less affected and there is no formation of granulomas. Aside from kidney and lung complications, those living with MPA may experience stomach or intestinal issues, nerve damage, and skin symptoms.

How do you treat ANCA-associated vasculitis?

There is no cure for ANCA-associated vasculitis, but treatments are available to help manage the disease. A combination of immunosuppressantsDrugs that suppress your immune system., including steroids, is commonly prescribed. The goal of treatment is to help you achieve and sustain remissionThe period in which a disease and its symptoms decreases or subsides. by reducing inflammation.

However, some immunosuppressantsDrugs that suppress your immune system. can be toxic. While steroids may help with your ANCA-associated vasculitis, they are harmful when used at higher doses and for a long period of time. Long-term use of steroids may cause side effects that include diabetes, weight gain, heart disease, osteoporosis, and changes to your appearance.

Additionally, relapseA return of symptoms and disease that had previously improved. is persistent with some immunosuppressantsDrugs that suppress your immune system. . While relapse is common with ANCA-associated vasculitis, it is often associated with serious damage to vital organs.

Up to 50% of people living withwith ANCA-associated vasculitis experience relapse.
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You are
 not alone. 

ANCA-associated vasculitis is a serious but
treatable disease.You and your doctor will work on
a treatment plan that works for you.

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About TAVNEOS

Important Safety Information

What is the most important information I should know about TAVNEOS?

TAVNEOS can cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems. Call your healthcare provider right away if you have unexplained symptoms such as:
  • yellowing of your skin or the white part of your eyes (jaundice)
  • pain on the upper right side of your stomach area (abdomen)
  • feeling tired
  • dark or brown (tea colored) urine
  • bleeding or bruising more easily than normal
  • loss of appetite
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark or brown (tea colored) urine
  • pain on the upper right side of your stomach area (abdomen)
  • bleeding or bruising more easily than normal
  • feeling tired
  • loss of appetite

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

Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients in TAVNEOS.

  • Get medical help right away if you experience swollen lips, tongue, throat, trouble swallowing, or difficulty breathing. These could be signs of an allergic reaction. Do not take more TAVNEOS until you have consulted with your healthcare provider.

Before taking TAVNEOS, tell your healthcare provider about all your medical conditions, including if you:

  • have or have had abnormal liver blood tests.
  • have or have had liver problems.
  • have or think you may have hepatitis B or C.
  • have an infection.
  • are pregnant or are planning to become pregnant. It is not known if TAVNEOS will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • 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.

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 may cause serious side effects, including:

  • Liver problems (see above).
  • Serious allergic reactions. Stop taking TAVNEOS and get emergency medical help right away if you have any of the following signs of a serious allergic reaction: shortness of breath or trouble breathing; swollen lips, tongue, throat, or face; trouble swallowing; chest pain; feeling dizzy or faint; moderate or severe abdominal pain, or vomiting.
  • Hepatitis B virus (HBV) reactivation. If you have had HBV or are a carrier of HBV, taking TAVNEOS could cause the virus to become an active infection again. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or the white part of your eyes during treatment with TAVNEOS.
  • Serious infections. Serious infections can happen in people taking TAVNEOS, and these infections can lead to death. The most common serious infections with TAVNEOS were pneumonia and urinary tract infections. People with serious infections should not take TAVNEOS. Tell your healthcare provider right away if you have any symptoms of infection: fever, cold symptoms that do not go away, flu symptoms, pain during urination, or other signs of infection.

The most common side effects of TAVNEOS include:

  • nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness, stomach pain, dizziness, increase in blood creatinine, and burning or prickling sensation.

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active anti-neutrophil cytoplasmic autoantibody(ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [MPA]).

It is not known if TAVNEOS is safe and effective in children under the age of 18.

These are not all the possible side effects of TAVNEOS. Call your doctor for medical advice about side effects. Please see the Full Prescribing Information and Medication Guide for further details.

TAVNEOS is available as a 10 mg capsule.

You are encouraged to report negative side effects to 1-833-828-6367 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TAVNEOS?

TAVNEOS can cause serious side effects, including:

  • Liver problems. People taking TAVNEOS may have serious liver problems.
    Call your healthcare provider right away if you have unexplained symptoms such as:

What is TAVNEOS?

TAVNEOS is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe active