Who May Benefit from 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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Could TAVNEOS® be right for you?

Take a look at the examples below. If any of these stories sound familiar to you, let your doctor know. Understanding how severe active GPA or MPA may be affecting you can help you and your doctor find a treatment plan together.

Hypothetical TAVNEOS® patient with ongoing symptoms from severe GPA
Ongoing Symptoms
Hypothetical TAVNEOS® patient newly diagnosed with severe active MPA
New Diagnosis
Hypothetical TAVNEOS® patient with relapsing symptoms from severe active MPA
Relapsing
Hypothetical TAVNEOS® patient with ongoing symptoms from severe GPA
patient-story-man-mobile

Diagnosed with severe GPA, has ongoing symptoms

About Peter:

Peter, a 49-year-old dental technician, enjoys sustainable gardening and farm-to-table cooking for his family. Currently planning a backyard greenhouse.

Symptoms:

Fever, fatigue, cough, hearing loss, blood-crusted nostrils

Diagnosis story:

Went to multiple doctors, and eventually saw a rheumatologist hoping to get some answers about his symptoms. After having a few tests done, he was diagnosed with severe active GPA.

TAVNEOS® story:

A medication called rituximab and glucocorticoids helped a bit. His cough, fatigue, hearing loss, and blood-crusted nostrils are ongoing, so his rheumatologist added TAVNEOS® to his treatment to help manage these symptoms.

Hypothetical TAVNEOS® patient newly diagnosed with severe active MPA
Hypothetical TAVNEOS® patient newly diagnosed with severe active MPA

Newly diagnosed with severe active MPA

About Nancy:

Nancy, a 62-year-old school administrator, enjoys traveling with her husband and spending time with her grandchildren.

Symptoms:

Fatigue, red spots on legs, fever, blood in urine

Diagnosis story:

Feeling fatigued, Nancy went to see her doctor. A month later she went to the ER with a fever and blood in her urine, where she was diagnosed with severe active MPA after a kidney biopsy.

TAVNEOS® story:

Immediately started on glucocorticoids and a medication called rituximab in combination with TAVNEOS®. After some time, she continued rituximab and TAVNEOS®, while slowly lowering her dose of glucocorticoids and only using them as needed.

Hypothetical TAVNEOS® patient with relapsing symptoms from severe active MPA
Hypothetical TAVNEOS® patient with relapsing symptoms from severe active MPA

Has severe active MPA, now relapsing after a couple of years

About Rebecca:

Rebecca, a 41-year-old real estate agent, owns a franchise and has ambitious growth goals.

Symptoms:

Hearing loss, blurry vision, light sensitivity, cough

Diagnosis story:

Diagnosed with severe active MPA several years earlier and placed on a medication called rituximab. She experienced side effects, and was switched to cyclophosphamide and steroids.

TAVNEOS® story:

When her symptoms got worse, she first thought it was just stress, but decided to see her doctor. Tests showed inflammation in her eye and worsening hearing, confirming she was relapsing. She didn’t want to increase her glucocorticoids again, so her doctor added TAVNEOS® to her treatment.

Own the conversation with your doctor using this helpful guide.

Find out everything you need to know about starting 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: