Frequently Asked Questions About TAVNEOS® (avacopan)

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

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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About TAVNEOS®
About Severe Active ANCA-associated Vasculitis
About Support

Frequently asked questions about severe active ANCA-associated vasculitis (GPA and MPA) and TAVNEOS®

About TAVNEOS^®

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.

Talk to your healthcare provider to find out if TAVNEOS^® may be an option for you.
How does TAVNEOS^® work?
When neutrophils, a type of immune cell in the body, become activated, the activation leads to the production of a protein called C5a. C5a attaches itself to a receptor called the C5a receptor, or C5aR.

This process plays a role in worsening the inflammation of blood vessels in ANCA-associated vasculitis (GPA and MPA).

Avacopan, the active ingredient in TAVNEOS^®, blocks the interaction between C5a and C5aR.

Your healthcare provider can help you better understand how TAVNEOS^® works in your body.

The exact way in which TAVNEOS^® works in severe active GPA and MPA isn’t completely understood.
What are the possible side effects associated with TAVNEOS^®?
TAVNEOS^® may 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)

dark or brown (tea colored) urine

pain on the upper right side of your stomach area (abdomen)

bleeding or bruising more easily than normal

feeling tired

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^®

Serious allergic reactions. TAVNEOS^® may cause 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. Before you take TAVNEOS^®, your healthcare provider will do blood tests to check for hepatitis B (HBV) infection. If you have had hepatitis B or are a carrier of hepatitis B virus, taking TAVNEOS^® could cause the virus to become an active infection again. Your healthcare provider may decide to stop TAVNEOS^® and any other medicines if you have active hepatitis B liver disease. Your healthcare provider will tell you if and when you can start taking TAVNEOS^® again. Your healthcare provider will monitor you for hepatitis B infection during and for six months after you stop taking TAVNEOS^®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or 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, such as runny nose or sore throat that do not go away

flu symptoms, such as cough, tiredness, and body aches

earache or headache

pain during urination

cold sores in mouth or throat

cuts, scrapes, or incisions that are red, warm, swollen, or painful

The most common side effects of TAVNEOS^® include:

nausea

headache

high blood pressure

diarrhea

vomiting

rash

tiredness

stomach pain

dizziness

increase in blood creatinine

burning or prickling sensation

These are not all the possible side effects of TAVNEOS^®.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How do I know if TAVNEOS^® could be right for me?
You may be eligible for TAVNEOS^® if ALL of the following criteria are met:

You are an adult diagnosed with severe active GPA or MPA

You are currently (any of the below):

in process of starting treatment for severe active GPA or MPA

on treatment for severe active GPA or MPA

experiencing relapse of severe active GPA or MPA
Who should not take TAVNEOS^®?
Do not take TAVNEOS^®:

if you are allergic to avacopan or any of the other ingredients in TAVNEOS^®. See the end of the Medication Guide for a complete list of the 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 of TAVNEOS^® until you have consulted with your healthcare provider.
Where can I find more information about TAVNEOS^®?
Always speak with your healthcare provider about questions you may have about your health and treatments, including whether TAVNEOS^® is the right treatment for you.
What should I tell my doctor before taking TAVNEOS^®?
Before taking TAVNEOS^®, tell your healthcare provider about all your medical conditions, including whether you:

have or have had abnormal liver blood tests.

have or have had liver problems.

have or think you may have hepatitis B or hepatitis 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.
How should I take TAVNEOS^®?
Take TAVNEOS^® exactly as your healthcare provider tells you to take it. Do not stop taking TAVNEOS^® unless your healthcare provider tells you to.

Check with your healthcare provider or pharmacist if you are not sure.

Take 3 capsules of TAVNEOS^® 2 times daily (morning and evening) with food.

Your healthcare provider may tell you to take 3 capsules of TAVNEOS^® 1 time each day if you take certain medicines. Tell your healthcare provider about all the medicines you take.

Swallow the capsules whole with water. Do not crush, chew, or open the capsules.

If you miss a dose of TAVNEOS^®, do not take the missed dose. Take the next dose at your regular time. Do not double your next dose.

If you have taken too much TAVNEOS^®, call your doctor or a Poison Control Center, or go to the nearest hospital emergency room.
What should I avoid while taking TAVNEOS^®?
Make sure to talk to your healthcare provider about what you should avoid while taking TAVNEOS^®.

Always tell your healthcare provider about all the medicines you take. Your doctor may not prescribe TAVNEOS^® if you are taking certain other medications or may discontinue those medications.
What should I do if I miss a dose of TAVNEOS^®?
If you miss a dose of TAVNEOS^®, do not take the missed dose. Take the next dose at your regular time. Do not double your next dose.

About ANCA-associated vasculitis

What is severe active ANCA-associated vasculitis (GPA or MPA)?
Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis 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.

The 2 most common types of ANCA-associated vasculitis are GPA (granulomatosis with polyangiitis, previously called Wegener’s granulomatosis) and MPA (microscopic polyangiitis).

Active disease means that you have signs and/or symptoms of the disease that are new, ongoing, or getting worse

Severe disease is deﬁned as AAV with signs and/or symptoms that are organ- or life-threatening Find out more about GPA or MPA
What causes ANCA-associated vasculitis (AAV)?
Anti-neutrophil cytoplasmic antibodies, known as ANCA, cause the immune system to target the blood vessels. This causes inflammation in the blood vessels, which restricts blood flow. This can cause impaired organ function in many different parts of the body, leading to serious complications that affect the kidneys, lungs, or skin.

When ANCAs attach to neutrophils, which are a type of immune cell, they “program” these cells to attack blood vessels in the body. These blood vessels become swollen and inflamed. This is how vasculitis—inflammation of the blood vessels—occurs.
Where can I go to learn more about ANCA-associated vasculitis and about patients currently living with AAV?
There are three well-regarded national organizations from which you can learn more about ANCA-associated vasculitis:

The Vasculitis Foundation may be reached by phone at 1-816-436-8211, or you can visit the website at vasculitisfoundation.org

The National Organization for Rare Disorders may be reached by phone at 1-800-999-6673, or you can visit the website at rarediseases.org

The American Kidney Fund may be reached by phone at 800-638-8299, or you can visit the website at kidneyfund.org

About support

What is TAVNEOS^® Connect?*
TAVNEOS^® Connect is a patient support program designed to help you manage your journey right from the start.

TAVNEOS^® Connect offers a wide range of support and can:

help you understand insurance benefits and assist with copay support, if eligible

offer resources to help you learn about TAVNEOS^®

connect you with communities that can support you during your treatment journey

For questions, call the TAVNEOS^® Connect Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, then option 1, Monday through Friday from 8 am to 8 pm ET.

*
TAVNEOS^® Connect services are only available for patients whose diagnosis is aligned with the FDA-approved indication for TAVNEOS^®. Additional eligibility criteria may apply. Terms and conditions and other program restrictions apply.
Where can I enroll in TAVNEOS^® Connect?

Visit https://tavconnectrxpatient.iassist.com/patient to complete enrollment online.

Or call the TAVNEOS^® Connect Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, then option 1, Monday through Friday from 8 am to 8 pm ET.
What happens if there is a delay with my insurance coverage?

Please discuss options with your healthcare provider. Depending on your insurance coverage and other criteria, you may be eligible for the TAVNEOS^® Connect Quick Start Program.
What is the TAVNEOS^® Connect Copay Program and how can I enroll?

The TAVNEOS^® Connect Copay Program helps eligible commercially insured patients reduce out-of-pocket costs. Your copay may be as little as $0 for a month supply. There are no financial or income requirements for the copay program. Eligibility requirements and program limits apply.^†

The TAVNEOS^® Connect Team and Network Specialty Pharmacies work together to enroll all patients who are eligible for copay support. The Specialty Pharmacy will contact you directly each month to coordinate shipment to your home.

You can also visit https://tavconnectrxpatient.iassist.com/patient to complete enrollment online.

^†
Other restrictions may apply. This program is not open to patients receiving prescription reimbursement under any federal-, state-, or government-funded healthcare program, or for cash patients. This is not insurance or a guarantee of payment. No cash value. Void where prohibited by law.
Will the pharmacy I use accept my copay card for TAVNEOS^®?

TAVNEOS^® is not available through retail pharmacies. The Specialty Pharmacies within the TAVNEOS^® network will accept the TAVNEOS^® Connect Copay Card.
How much will TAVNEOS^® cost?

Medication out-of-pocket costs will vary based on your insurance coverage.
How can I find more information about the Patient Assistance Program?

For eligible patients who are uninsured or are unable to afford their medication, the Patient Assistance Program may help provide access to TAVNEOS^®. You must meet eligibility criteria related to age, diagnosis, income, residency, and insurance status.

For questions, call the TAVNEOS^® Connect Team at 1-833-TAVNEOS (1-833-828-6367) and choose option 2, then option 1, Monday through Friday from 8 am to 8 pm ET.

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:

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