How to Take 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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What should I ask my doctor about TAVNEOS®?

Hypothetical TAVNEOS® (avacopan) patient
Hypothetical TAVNEOS® (avacopan) patient

You can write down or take a screenshot of these questions and bring them to your appointment

  • What does successful management for my severe active GPA or MPA look like?
  • How could TAVNEOS® enhance my current treatment regimen?
  • How could TAVNEOS® help me reach and stay in remission?
  • When could I start to see a difference from my severe active GPA or MPA treatment regimen?
  • What are the side effects of TAVNEOS®?
  • When do I add TAVNEOS® into my treatment regimen?
Own the conversation with your doctor using this helpful guide.

Is TAVNEOS® right
for me?

TAVNEOS® is a prescription medicine for adult patients with severe active GPA or MPA that is added to your current
treatment. It is not known if TAVNEOS® is safe and effective for children under the age of 18.

Patients may be eligible for TAVNEOS® when ALL of the following criteria are met:

1. Adults diagnosed with the following types of severe active ANCA-associated vasculitis:

  • Severe active GPA or MPA

2. Patient is 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

Talk with your doctor about whether TAVNEOS® is right for you.

How do I take
TAVNEOS®?

TAVNEOS® (avacopan) dosing
TAVNEOS® (avacopan) dosing
Take 3 capsules (10 mg each) of
TAVNEOS® twice a day with food.
Make sure you talk to your doctor about
how and when to take TAVNEOS®.

Take TAVNEOS® exactly as your doctor tells you to take it

  • Do not stop taking TAVNEOS® unless your doctor tells you to
  • Check with your doctor or pharmacist if you are not sure

Your doctor may tell you to take 3 capsules of TAVNEOS® once each day if you take certain medicines

  • Tell your doctor 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 the next dose

Store TAVNEOS® capsules at room temperature

  • Temperature of 68°F to 77°F (20°C to 25°C)

Keep TAVNEOS® and all medicines out of reach of children.

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 consider
before starting TAVNEOS®?

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.

Who should not take TAVNEOS®?

  • Do not take TAVNEOS® if you are allergic to avacopan or any of the other ingredients of this medicine
  • See the Medication Guide for a complete list of the ingredients in TAVNEOS®

Find out what 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: