Last updated, May 22, 2026

At Amgen, patient safety is our highest priority and we are committed to providing information in a timely manner around frequently asked questions related to TAVNEOS®. As always, patients should discuss any treatment decisions or questions with their healthcare provider.

TAVNEOS is a treatment for ANCA-Associated Vasculitis (AAV) (Severe Active GPA or MPA).

TAVNEOS was approved by the FDA in October of 2021 and has been available and used by patients for nearly five years. Hepatotoxicity is a known risk of TAVNEOS treatment for AAV U.S. prescribing information has included information on the risk of serious liver injury (hepatotoxicity), as well as liver monitoring and treatment discontinuation guidance for physicians and patients, since FDA approval. The FDA recently issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases including fatal cases of drug-induced liver injury associated with TAVNEOS. To date, there have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS. Amgen continues to closely monitor safety information and works with health authorities to keep patients and healthcare providers informed. Patients should talk with their doctor about the benefits and risks of TAVNEOS and what it means for their individual care.

Amgen remains confident in TAVNEOS risk-benefit profile and that TAVNEOS has an important role in treating people with severe, active ANCA-associated vasculitis.

  1. Is TAVNEOS still available? Will I still be able to get my next prescription or refill?

    Yes, TAVNEOS remains available: there is no change to Tavneos’ approval status, use or availability. Patients currently receiving TAVNEOS should not make changes related to their treatment without first consulting the healthcare provider who prescribed the medicine. 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. Please contact Amgen Medical Information at 1-800-772-6436 (Monday - Friday, 8am-8pm EST) with any product-related questions.

  2. Is TAVNEOS 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 conduct blood tests to check how well your liver is working.
    • The FDA recently issued a Drug Safety Communication notifying patients and health care professionals about serious postmarketing cases including fatal cases of drug induced liver injury associated with TAVNEOS. To date, there have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS.
    • Amgen continues to closely monitor safety information and works with health authorities to keep patients and healthcare providers informed. Patients should talk with their doctor 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).

  3. What should patients know about reports of deaths due to serious liver injury in people treated with TAVNEOS?

    • Recently, Japanese pharmaceutical company Kissei reported that out of over 8,500 patients who had been treated with TAVNEOS in Japan, there had been 20 fatal cases of serious liver injury. These figures include cases for which a causal relationship with the product could not be determined.
    • Health authorities in Japan have decided to update the Japanese prescribing information to include detailed information on liver test monitoring and treatment discontinuation rules and updated information on the cases of serious hepatic function disorder, including vanishing bile duct syndrome, that have been reported.
    • Since FDA approval in 2021, the U.S. prescribing information has included the risk of serious liver injury (hepatotoxicity) and has provided specific liver monitoring guidance for physicians and patients.
    • To date, there have been no known deaths in the U.S. linked to serious liver injury, including vanishing bile duct syndrome (VBDS), in the more than 8,000 patients in the U.S. treated with TAVNEOS.

  4. What updates has the FDA shared about TAVNEOS?

    • 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 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 current U.S. label includes a warning about liver toxicity and guidance for your doctor to conduct 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.
      • In clinical trials for TAVNEOS, serious liver injury was observed. Since approval in 2021, cases of VBDS 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.
    • On April 30, 2026, the FDA issued a notice to the Federal Register proposing to withdraw TAVNEOS from the U.S. Market, asserting new information suggests TAVNEOS has not been shown to be effective, and that ChemoCentryx’s original application to the FDA for approval of TAVNEOS included material misstatements.
    • Amgen disagrees with the FDA’s assessment. Based on the clinical data and real-world evidence demonstrating the effectiveness and favorable benefit–risk profile, Amgen remains confident that TAVNEOS is an important treatment option for patients with severe active ANCA-associated vasculitis, including the more than 8,000 patients who have been treated since its FDA approval in 2021.
    • Amgen is actively engaging with the FDA to evaluate next steps and determine the most appropriate path forward, while keeping patient safety, needs, and support at the forefront.

  5. Am I able to share my experience with the FDA for consideration?

    Yes, the FDA is accepting public comments regarding its proposal to withdraw approval of TAVNEOS. Comments may be submitted anonymously if preferred. The public comment period is open through June 29, 2026. You may submit public comments here.

  6. When will there be a resolution or final decision about FDA’s proposal to withdraw TAVNEOS from the market?

    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.

  7. 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.

  8. 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.