What is ANCA-Associated Vasculitis (AAV)? | TAVNEOS® (avacopan)

Approved Use: TAVNEOS® is a prescription medicine that is used with other medicines (such as glucocorticoids) to treat adults with severe

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Approved Use: 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.

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What is AAV?

ANCA-associated vasculitis (AAV) is a group of rare autoimmune diseases that affect blood vessels throughout your body

In AAV, inflammation of small- to medium-sized blood vessels leads to reduced blood flow and impaired organ function. It is not known what causes these diseases, but it is thought to be a combination of factors, including genetics and the environment.

Active disease means that you have signs and symptoms of the disease that are new, not getting better, or getting worse.*

Severe disease is defined as GPA or MPA with signs and symptoms that are organ- or life-threatening.

*This does not include signs and symptoms related to past damage.

What are GPA and MPA?

GPA and MPA are the 2 most common subtypes of AAV

Severe active GPA and MPA are serious but treatable. You and your doctor will decide on a treatment plan that is best for you.

granulomatosis-with-polyangiitis-mb

Granulomatosis with polyangiitis (GPA)

In GPA, immune cells clump together, forming what are known as granulomas. GPA also causes inflammation of the blood vessels. It can affect the whole body, but often affects the kidneys, lungs, sinuses, nose, ears, and throat.

Kidneys Lungs Nose Ears

Microscopic polyangiitis (MPA)

MPA shares many signs and symptoms with GPA, but does not include granulomas. MPA is more likely to affect the kidneys, and cause uncontrolled bleeding in the lungs.

Kidneys Lungs
If you’re having new, worsening, or ongoing symptoms, talk to your doctor right away

Understanding Severe Active GPA and MPA

Own the conversation with your doctor using this helpful guide.

Join nephrologist Dr. Dia Waguespack as she discusses what it means to live with severe active GPA and MPA. Tune in to learn more about signs and symptoms, goals of care, and approaches and challenges to treatment of GPA and MPA.

What are the signs and symptoms?†

Talk to your doctor if you are having issues in any of the areas listed below:*

Tap each body part to learn more

Eyes Irritated eyes, blurred vision Ears Hearing loss Nose Crusted blood around nostrils, stuffy nose Heart Chest pain Digestive System Bloody diarrhea, stomach pain Lungs Trouble breathing, wheezing Nervous System Headache, numbness or tingling in the arms and legs Kidneys Blood in urine Skin Rashes, sore spots, blisters General Muscle pain, joint pain
If you’re having new, worsening, or ongoing signs and symptoms, talk to your doctor right away.
†

Please note that everyone experiences GPA or MPA differently and these are just some of the signs and symptoms.

~80%-90% of people with AAV have kidney- or other organ-threatening signs and symptoms, which can be severe active disease.

  • Multiple minor signs and symptoms of GPA/MPA can be considered active disease

What can I expect with treatment?

A goal of severe active GPA and MPA treatment is to reach remission and stay in remission, and reduce the risk of relapse

Remission Absence of GPA or MPA signs and symptoms, on or off treatment
Relapse When GPA or MPA signs and symptoms return after being in remission
Hypothetical TAVNEOS® (avacopan) patient
Hypothetical TAVNEOS® (avacopan) patient

GPA and MPA are serious, long-term diseases. There may be times when symptoms get worse and other times when they seem to get better. Although there is no cure, there are treatments that can help people achieve remission.

Even with treatment, some people may continue to have signs and symptoms. They may benefit from an update to their treatment plan. If you are having any symptoms that you think may be related to severe active GPA or MPA, be sure to talk to your doctor right away.

‡According to an online, self-administered survey of 100 people with GPA or MPA from July 21-August 25, 2022.

While there are several types of doctors who treat GPA and MPA, speaking with a rheumatologist is a good place to
start. You can find one below with this helpful tool from the American College of Rheumatology (ACR).

Find a rheumatologist

How are severe active GPA and MPA treated?

Finding the right treatment can help make a difference

Your doctor may prescribe glucocorticoids, also known as steroids, like prednisone, and other immunosuppressants such as rituximab or cyclophosphamide, which help reduce inflammation in the body.

Treatment with steroids

Steroids can be effective but may come with side effects often related to how much and how long steroids are used.

Treatment with other immunosuppressants

Doctors may use other immunosuppressants such as rituximab or cyclophosphamide, which help reduce inflammation in the body.

TAVNEOS® can be added to treatment

Check out these tips for managing
your severe active GPA or MPA

It can be tough managing your severe active GPA or MPA, but there are steps you can take to stay organized and take care of your condition. This may include requests from your doctor, as well as working to manage GPA or MPA between visits.

  • Take your medicine as it is prescribed by your doctor
  • Keep up with all your doctors’ appointments and health-related exams
  • Track your GPA or MPA, including symptoms, treatment side effects, and any positive or negative changes you’ve noticed
  • Find vasculitis support groups, either local or on social media, where you can talk to others who may have had similar experiences
  • Talk to your doctor about any side effects you may be having from any of your medications

You may need to adjust your daily routine to manage your symptoms, and that’s okay! Work with your doctor to find the best way to manage them.

Own the conversation with your doctor using this helpful guide.

Could TAVNEOS® help you or a loved one struggling with severe active GPA or MPA?

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

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 Amgen at 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: yellowing of your skin or the white part…

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: