Last updated, April 1, 2026

  1. 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 the only FDA-approved, targeted oral treatment for severe active GPA and MPA.

  2. What recent updates has the FDA shared about TAVNEOS?

    • January 16, 2026 – FDA request for voluntary withdrawal
      • TAVNEOS was developed by ChemoCentryx, Inc. and approved by the FDA in October 2021. Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year. On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market.
      • The FDA has questions about how data from a small number of patients were assessed in the Phase 3 pivotal clinical trial. Hepatotoxicity (liver problems) was also raised in the context of the benefit-risk profile of the medicine.
      • On January 28, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market.
    • March 31, 2026 – FDA Drug Safety Communication
      • On March 31, 2026, the FDA issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases of drug-induced liver injury, some fatal, associated with TAVNEOS.
      • The majority of these cases have been reported from outside the U.S., primarily from Japan.
      • The current U.S. label includes a warning about liver toxicity and guidance for your doctor to monitor your blood tests to check how well your liver is working. The Drug Safety Communication provides additional information about drug induced liver injury associated with TAVNEOS.

  3. What did the FDA say in the March 2026 Drug Safety Communication?

    The FDA issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases of drug-induced liver injury associated with TAVNEOS.

    The current U.S. label includes a warning about liver toxicity and guidance for monitoring patients. The Drug Safety Communication provides additional information about drug induced liver injury associated with TAVNEOS.

    In clinical trials for TAVNEOS, serious liver injury was observed. Since approval in 2021, cases of vanishing bile duct syndrome (VBDS), a rare and severe liver injury that can be fatal, have been reported primarily from Japan. Most patients who have had VBDS were aged 65 years and older and most cases occurred within 90 days of starting TAVNEOS. VBDS has been fatal in some of these patients.

    Patient safety always comes first, and Amgen is in regular communication with the FDA about the safety of our medicines.

  4. Is TAVNEOS still available?

    Yes, TAVNEOS is still available to patients.

  5. Can I keep taking TAVNEOS?

    Yes. Patients currently receiving TAVNEOS should not make changes related to their treatment without first consulting the healthcare provider who prescribed the medicine. Please contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST) with any product-related questions.

  6. Is TAVNEOS still safe to use?

    As always, the safety of patients remains our priority. Amgen remains confident that TAVNEOS is an important and effective medicine for the treatment of severe active ANCA-associated vasculitis (GPA/MPA).

    Hepatotoxicity (liver problems) is a known, risk of TAVNEOS and was included in the approved label in 2021 with guidance for your doctor to monitor your blood tests to check how well your liver is working.

    The Drug Safety Communication issued by the FDA on March 31, 2026 provides additional information about drug induced liver injury associated with TAVNEOS.

    TAVNEOS has been studied in clinical trials and has been used by more than 7,000 patients since it was approved by the FDA in 2021. Based on this clinical trial data and real-world experience, Amgen remains confident that TAVNEOS has an important role in treating people with severe, active ANCA-associated vasculitis.

    Amgen continues to closely monitor safety information and works with health authorities to keep patients and healthcare providers informed. Patients should talk with their healthcare provider about the benefits and risks of TAVNEOS and what it means for their individual care.

    For any additional questions, please contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST).

  7. What is Amgen doing to address the FDA’s questions?

    Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs, and support at the forefront.

  8. When will there be a resolution or final decision about voluntary withdrawal from the FDA?

    If the FDA were to pursue withdrawal of approval for TAVNEOS, the process could take months or longer to reach a final resolution. Amgen is engaging with the FDA to determine a path forward, with patient safety, needs, and support as our top priorities. In the meantime, work with your doctor.

  9. Will I still be able to get my next prescription or refill?

    At this time, TAVNEOS remains available. If you are currently taking TAVNEOS and have questions about getting your prescription, please talk with your pharmacy or your doctor who prescribed the medicine.

  10. Who should I talk to if I have questions about my care?

    If you have questions about your treatment or next steps, talk with your doctor or healthcare team. They are the best source of advice for your individual situation. You can also contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST) with any product-related questions.

  11. What should I do if I’m in a current TAVNEOS clinical trial?

    There is no change to ongoing TAVNEOS clinical trials at this time. If you have a question about your current clinical trial, please reach out directly to the clinical trial site coordinator.


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.

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.

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.