Avacopan

On March 31, 2026, the Food and Drug Administration (FDA) issued a drug safety warning about serious, and even fatal, cases of liver injury that has been reported with avacopan. All patient should talk with their doctor about the risks and benefits of continuing avacopan. Contact your doctor right away if you experience any of the following while taking avacopan: extreme tiredness, nausea, vomiting, unusual itching, light-colored stools, yellowing of skin or whites of eyes, dark urine, stomach or abdomen swelling, or pain in the abdomen.

Avacopan is used to treat granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis, conditions in which the body attacks its own veins and other blood vessels, that can cause damage to organs, such as the heart and lungs. Avacopan is in a class of medications called complement inhibitors. It works by blocking the activity of the part of the immune system that may damage veins and other blood vessels.

Avacopan comes as a capsule to take by mouth. Take two times a day (morning and evening) with food. Take avacopan at around the same times every day.

Take avacopan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with water; do not open, chew, or crush them.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking avacopan,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with avacopan. Other medications may cause dosing changes or extra monitoring when taken with avacopan. Make sure you have discussed any medications you are currently taking or plan to take before starting avacopan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking avacopan, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with avacopan: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medications before you start taking avacopan. Do not start any of these medications while taking avacopan without discussing with your healthcare provider.
• tell your doctor if you have or have ever had liver disease including hepatitis B or hepatitis C, cirrhosis (a disease which causes scarring of liver tissue), or any other liver problems. Also tell your doctor if you have or ever had tuberculosis (TB, a severe lung infection) or if you were recently around someone who has TB or visited or lived where TB is common, or if you have any type of infection now or if you have or have ever had an infection that would not go away or an infection that comes and goes.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking avacopan, call your doctor.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Avacopan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, stomach pain, diarrhea
• headache
• dizziness
• numbness or tingling in the fingers or toes
• tiredness
• rash

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately (or get emergency medical treatment):

• shortness of breath; difficulty breathing or swallowing; swelling of your face, tongue, or throat; sweating; chest pain; lightheadedness; fainting; hives; or itching
• yellowing of skin and eyes, pain or discomfort in right upper stomach area, fatigue, loss of appetite, bleeding or bruising more easily than normal, or dark urine
• sore throat, fever, chills, cough, earache, headache, muscle aches, or other signs of infection; warm, red, or painful skin; sores on the skin or in the mouth or throat; or frequent, painful, or burning feeling during urination

Avacopan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to avacopan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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