Avacopan

WHY is this medicine prescribed?

Avacopan is used in adults along with other medications 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Avacopan comes as a capsule to take by mouth. It is usually taken two times a day (morning and evening) with food. Take avacopan at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with avacopan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking avacopan,

• tell your doctor and pharmacist if you are allergic to avacopan, any other medications, or any of the ingredients in avacopan capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking avacopan. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• stomach pain
• 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.