Talk to Your Doctor | 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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Make your discussion count

Select the box for each symptom you’ve been experiencing.

These are just some of the signs and symptoms of severe active ANCA-associated vasculitis.

Talk to your doctor about all the symptoms you may be experiencing, including those not listed here.

How long have you been having these symptoms?

Is this a new or ongoing symptom?

ear

Ears:

hearing loss
3 months or less 4-6 months 1 year More than
a year
New Ongoing
eyes

Eyes:

irritated eyes, blurred vision
3 months or less 4-6 months 1 year More than
a year
New Ongoing
nose

Nose:

crusted blood around nostrils, stuffy nose
3 months or less 4-6 months 1 year More than
a year
New Ongoing
lungs

Lungs:

trouble breathing, wheezing or cough
3 months or less 4-6 months 1 year More than
a year
New Ongoing
nervous-system

Nervous system:

headache, numbness or tingling in the arms & legs
3 months or less 4-6 months 1 year More than
a year
New Ongoing
heart

Heart:

chest pain
3 months or less 4-6 months 1 year More than
a year
New Ongoing
kidney

Kidney:

blood in urine
3 months or less 4-6 months 1 year More than
a year
New Ongoing
digestion

Digestion:

bloody diarrhea, stomach pain
3 months or less 4-6 months 1 year More than
a year
New Ongoing
skin

Skin:

rashes, sore spots, blisters
3 months or less 4-6 months 1 year More than
a year
New Ongoing
general

General:

muscle pain, joint pain
3 months or less 4-6 months 1 year More than
a year
New Ongoing
other

Other
3 months or less 4-6 months 1 year More than
a year
New Ongoing

Over the past few weeks, have your symptoms made it hard to do any of the following?

Select all that apply or skip to the next section.

human-brain

Work

man-activity

Do other daily activities

How satisfied are you with your current treatment plan?

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Unsatisfied

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Somewhat satisfied

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Satisfied

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Your Personalized Doctor Discussion Guide is ready!

You can email it to yourself. Keep it handy at your next appointment so you can have an open conversation about severe active ANCA-associated vasculitis (GPA or MPA) with your doctor.

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Having open, detailed conversations can help you and your doctor understand how severe active ANCA-associated vasculitis (GPA or MPA) is affecting you.
ANCA = anti-neutrophil cytoplasmic autoantibody; GPA = granulomatosis with polyangiitis, previously called Wegener’s granulomatosis; MPA = microscopic polyangiitis.
border_line
MY DISEASE IMPACTS
work daily_activities
SATISFACTION WITH MY CURRENT TREATMENT
MY SYMPTOMS
Make sure to discuss with your doctor if any of your symptoms are worsening.
ears
Ears:
hearing loss
kidney
Kidney:
blood in urine
lungs
Lungs:
trouble breathing, wheezing or cough
lungs
Nose:
crusted blood around nostrils, stuffy nose
skin
Skin:
rashes, sore spots, blisters
heart
Heart:
chest pain
digestion
Digestion:
bloody diarrhea, stomach pain
general
General:
muscle pain, joint pain
eyes
Eyes:
irritated eyes, blurred vision
nervous_system
Nervous system:
headache, numbness or tingling in the arms & legs
other
Other
List any other symptoms you may be experiencing related to your severe active GPA or MPA

use this area to further explain any of you selections from the previous page if needed

PARTNERING WITH YOUR DOCTOR
border_line
Below are some questions that can help you and your doctor talk about important topics when it comes to your treatment and expectations.
treatment_and_expectations
This guide is for anyone who has been diagnosed with severe active GPA or MPA, their loved ones, or those who are unsure if they have this disease.
Please see additional Important Safety Information on the next page and click here for the Full Prescribing Information and Medication Guide.

What is Tavneos

TAVNEOS is a prescriptionmedicine that is usedwith other medicines (such as glucocorticoids) to treat adultswith severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA], formerly known as Wegener’s granulomatosis, and microscopic polyangiitis [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.

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 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: