Results with 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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TAVNEOS® can help you reach and stay in remission

TAVNEOS® was studied for 1 year in a clinical trial involving 330 people living with GPA or MPA

72% reached remission on TAVNEOS® (avacopan)

in the TAVNEOS® Group vs 70% in the Comparison Group

Comparable at 6 months of treatment

*In the study, remission was reaching a BVAS of 0 and not taking steroids for GPA or MPA within 1 month before month 6.

vs

66% stayed in remission on TAVNEOS® (avacopan)

in the TAVNEOS® Group vs 55% in the Comparison Group

Superior at 1 year of treatment

†In the study, sustained remission was a BVAS of 0 at month 6 and at 1 year, not using steroids for GPA or MPA within 1 month before month 6 and 1 year, and not relapsing between month 6 and 1 year.

Disease activity in the study was measured using the Birmingham Vasculitis Activity Score (BVAS), which measures new, worsening, or ongoing GPA and MPA disease activity in this clinical study. A higher score means more disease activity.

People in the TAVNEOS® Group received:

  • TAVNEOS® + rituximab
  • or
  • TAVNEOS® + cyclophosphamide, followed by azathioprine or mycophenolate mofetil‡

People in the Comparison Group received:

  • Prednisone (with a gradual reduction over time) + rituximab
  • or
  • Prednisone (with a gradual reduction over time) + cyclophosphamide, followed by azathioprine or mycophenolate mofetil‡

People in both groups could have received glucocorticoids, often called steroids, prescribed by their doctor as needed.

‡

If azathioprine was not tolerated.

Fewer relapses‡ at 1 year of treatment

54% lower risk of relapse at 1 year of TAVNEOS® (avacopan)
54-percent-mobile
  • 10% of people in the TAVNEOS® Group relapsed vs 21% of people in the Comparison Group
  • There is a possibility that the difference between treatments may have been due to chance alone and not due to TAVNEOS®, so these results were not considered significant and should be interpreted with caution
§

In the study, relapse was a return of 1-2 minor signs or symptoms 2 visits in a row, or at least 1 major or 3 minor signs or symptoms, after reaching a BVAS of 0. BVAS categorizes signs or symptoms as major or minor based on the impact to organs.

Could TAVNEOS® help my quality of life?

People in the TAVNEOS® Group showed more improvement in the mental and physical categories of quality of life vs those in the Comparison Group

According to a health-related quality-of-life survey**, people in the TAVNEOS® Group had improved their overall physical and mental scores.

  • Physical score improved by 5.0 compared to 2.6 in people in the Comparison Group at 1 year
  • Mental score improved by 6.4 compared to 4.7 in people in the Comparison Group at 1 year

The survey measured health-related quality of life using a survey, which included:

Physical

Physical

  • Body pain
  • Physical functioning
  • Difficulties with work or daily activities 
  • General health perception
Mental

Mental

  • Vitality
  • Mental health
  • Difficulties with work or daily activities 
  • Functioning in social settings
**

Based on responses to the Short-Form-36 version 2 (SF-36 V2), the survey was not designed specifically for GPA and MPA. In the survey, score ranges from 0 (worst) to 100 (best).

The difference between treatments was not significant, which means it may have been due to chance and not due to TAVNEOS®. These results should be interpreted with caution.

Including TAVNEOS® in your treatment may allow you to reduce your steroid use

People in the TAVNEOS® Group used less steroids compared to people in the Comparison Group during
the 1-year study

Median total dose of steroids

Average Total Dose of Steroids

People in the TAVNEOS® Group used an
average total dose of 1676 mg, which is

Mental

56%

less
steroids

compared to people in
the Comparison Group
(3847 mg)

People in both groups could have received steroids prescribed by their doctor as needed.

††The median total dose is the middle number between a set of numbers ordered from the lowest to the highest.

 

Could TAVNEOS® help improve my kidney function?

Kidney function improved, as measured by eGFR, for people who were in the TAVNEOS® Group vs those in the Comparison Group

Kidney function with TAVNEOS® (avacopan) Kidney function with TAVNEOS® (avacopan)

Estimated glomerular filtration rate (eGFR) measures kidney function. Generally, the higher the eGFR, the better the kidney function.

About 81% of people at the start of the study had kidneys that were affected.

At 1 year, people in the TAVNEOS® Group with affected kidneys showed greater improvement in kidney function vs people in the Comparison Group

There is a possibility the difference between the groups may have been due to chance alone and not due to TAVNEOS®, so these results were not considered significant. The improvement in kidney function with TAVNEOS® lessened when people stopped taking the medication at the end of the study, therefore, results should be interpreted with caution.

GPA = granulomatosis with polyangiitis; MPA = microscopic polyangiitis.

Find out what you need to know about taking 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

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: