About the Condition | TAVNEOS® (avacopan)

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

Read more

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.

Read less

You are now leaving this website

The link you have selected will take you away from the TAVNEOS® (avacopan) website to one that is not owned or controlled by ChemoCentryx. ChemoCentryx accepts no responsibility for the content of linked sites.

Cancel

OK

You are leaving the TAVNEOS® website

Do you wish to leave this site?
Yes No

Healthcare professionals website

The information contained in this section of the site is intended for U.S. healthcare professionals only. Click “OK” if you are a healthcare professional.

Cancel

OK

Based on your location, you are being redirected to the website of our licensee Vifor Fresenius Medical Care Renal Pharma Ltd. CCXI does not have responsibility for, or control of, the contents, availability, operation, or performance of the website.

Redirect

What is severe active ANCA-associated vasculitis (AAV)?

AAV is a group of rare diseases that affects small- to medium-sized blood vessels in your body

These diseases involve inflammation of the blood vessels, which reduces blood flow and could lead to impaired organ function. While your genetics and environment are thought to be contributing causes of these diseases, the exact cause isn’t known yet.

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

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

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are the 2 most common types of AAV

Severe active GPA and MPA are serious but treatable diseases. Your doctor will work with you to develop a treatment plan that suits your needs.

granulomatosis-with-polyangiitis-mb

Granulomatosis with polyangiitis (GPA)

GPA happens when immune cells clump together, forming what are known as granulomas. This causes inflammation in 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 symptoms with GPA, but can have a more severe impact on the kidneys. People with MPA may be at a higher risk of uncontrolled bleeding in their lungs.

Kidneys Lungs

Identifying the signs and symptoms of severe active GPA or MPA early can lead to a timely diagnosis that can help you and your doctor decide on a treatment plan to help manage your condition.

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

*

Please note these are just some of the signs and symptoms of severe active AAV. Severe active AAV can present differently in each patient.

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

  • Multiple minor signs and/or symptoms of AAV can be considered active disease

What can I expect with treatment?

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

Remission Absence of GPA or MPA symptoms
Relapse When GPA or MPA symptoms return after being previously controlled
Hypothetical TAVNEOS® (avacopan) patient
Hypothetical TAVNEOS® (avacopan) patient

Severe active GPA and MPA are long-term, progressive diseases. There may be times when symptoms appear to worsen, as well as other times when they seem to be improving. Although there is no cure, there are treatments that can help patients achieve remission.

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

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

How are severe active GPA and MPA treated?

Finding the right treatment can help make a difference

For treatment, your doctor may prescribe steroids known as glucocorticoids, such as prednisone, as well as other immunosuppressants to help control disease activity.

Treatment with glucocorticoids

Glucocorticoids can be effective, but they can also cause a number of side effects. In fact, a lot of the side effects are often directly related to how long a patient is treated with glucocorticoids. For this reason, doctors have started to move toward treatments that can reduce exposure to high-dose glucocorticoids.

Treatment with other immunosuppressants

One way to help people achieve remission and reduce the dose of glucocorticoids is by using other immunosuppressants. Immunosuppressants are medications that target inflammation by lowering the activity of the body’s immune system. These medications have become part of the standard treatment for severe active GPA and MPA.

Check out these tips to help with your severe
active GPA or MPA treatment experience

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 progress, such as positive changes, symptoms, and treatment side effects and share them with your doctor
  • Find vasculitis support groups, either local or on social media, where you can talk to others who understand your experiences

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.

TAVNEOS® is a targeted oral treatment that is used with other medications to help treat adults with severe active GPA or MPA.

TAVNEOS® works differently than other immunosuppressants. Once added to your current treatment, TAVNEOS® is specifically designed to block a receptor involved in GPA and MPA, helping to reduce inflammation. The exact way in which TAVNEOS® works in severe active GPA and MPA isn’t completely understood.

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: