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® may help you reach and stay in remission

TAVNEOS® was studied for 52 weeks in a clinical trial involving 330 people living with GPA or MPA

Comparable at 6 months of treatment

72%

of people treated with TAVNEOS® in combination with additional immunosuppressive therapy
reached remission*

vs

vs 70%

of people taking
Standard Therapy

*

In the study, remission was defined as achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks prior to Week 26.

Superior at 1 year of treatment

66%

of people treated with TAVNEOS® in combination with additional immunosuppressive therapy
stayed in remission†

vs

vs 55%

of people taking Standard Therapy

†

In the study, sustained remission was defined as remission at Weeks 26 and 52 without relapse between Week 26 and Week 52. Remission at Week 52 was defined as BVAS of 0 and not taking glucocorticoids for treatment of GPA or MPA within 4 weeks of Week 52.

Fewer relapses‡ at 1 year of treatment

54%

Lower risk of relapse for people treated with TAVNEOS® in combination with additional immunosuppressive therapy compared to people treated with Standard Therapy

  • 21% of people treated with Standard Therapy relapsed vs 10% of people treated with TAVNEOS® in combination with additional immunosuppressive therapy
  • 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 defined as a return of GPA or MPA activity on the basis of at least 1 major item, at least 3 non-major items, or 1 or 2 non-major items for at least 2 consecutive visits on the BVAS after remission (BVAS of 0) had been achieved.

Immunosuppressive therapy: rituximab or cyclophosphamide followed by azathioprine or mycophenolate mofetil (if azathioprine was not tolerated).

Standard Therapy: immunosuppressive therapy and a gradual reduction of prednisone over time.

In the study, patients were allowed glucocorticoids not supplied as part of the study medication.

Could TAVNEOS® help my quality of life?

TAVNEOS® helped improve quality of life in the study

According to a quality-of-life survey,§ people treated with TAVNEOS® and additional immunosuppressive therapy had scores that showed greater improvement than those treated with Standard Therapy. From the start of the study to Week 52, people in the TAVNEOS® group had an improvement in their overall:

  • Physical score of 5.0 compared to 2.6 in people on Standard Therapy
  • Mental score of 6.4 compared to 4.7 in people on Standard Therapy

The survey assessed both physical and mental health categories, which included:

Physical

Physical

  • Body pain
  • Physical functioning
  • Difficulties with work or daily activities due to physical health problems
  • General health perception
Mental

Mental

  • Vitality
  • Mental health
  • Difficulties with work or daily activities due to emotional health problems
  • Functioning in social settings
§

Based on responses to the Short Form-36 version 2 (SF-36 V2) survey. The SF-36 V2 survey was not developed specifically for patients with severe active GPA or MPA. Additionally, 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. Results should be interpreted with caution.

Could TAVNEOS® help reduce my reliance
on glucocorticoids?

Including TAVNEOS® with your therapy regimen may allow you to reduce your reliance on glucocorticoids

Down arrow

People who took TAVNEOS® with additional immunosuppressive therapy through Week 52 of the study used less glucocorticoids

Everyone in the study was allowed to use glucocorticoids as needed regardless of what treatment they used. However, those treated with TAVNEOS® in combination with additional immunosuppressive therapy compared to those treated with Standard Therapy had a lower median total dose of glucocorticoids of 81% (TAVNEOS® = 600 mg; Standard Therapy = 3097.5 mg), and a lower mean total dose of glucocorticoids of 56% (TAVNEOS® = 1675.5 mg; Standard Therapy = 3846.9 mg).

Could TAVNEOS® help improve my kidney function?

Kidney function improved for adults who used TAVNEOS® in combination with additional
immunosuppressive therapy

Kidneys
  • About 81% of people had kidney involvement at the start of the study

To see how well your kidneys are working, your doctor may check the estimated glomerular filtration rate (eGFR). Generally, the higher the eGFR the better the kidney function.

  • At Week 52, people treated with TAVNEOS® with additional immunosuppressive therapy had a difference in eGFR of 7.3 mL/min/1.73 m2 compared to a 4.1 mL/min/1.73 m2 change for people treated with Standard Therapy
  • 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. Also the difference between treatments was reduced when patients stopped taking TAVNEOS® at the end of the study. Therefore, results should be interpreted with caution

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: