Avacopan is used with other medicines (including glucocorticoids) to treat adults with granulomatosis with polyangiitis (previously known as Wegener's granulomatosis). avacopan is also used to treat adults with microscopic polyangiitis.

Avacopan may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose if you take certain medicines. Use the medicine exactly as directed.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests before you start treatment with avacopan, while using avacopan and for several months after you stop using it.

Take 3 capsules of avacopan twice a day (morning and evening) with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Vasculitis:

Recommended dose: 30 mg orally twice a day with food

Comments:
-Obtain liver function tests and screen for hepatitis B prior to treatment initiation.
-Consider monitoring WBC count before starting therapy.
-This drug is used in combination with standard therapy, including glucocorticoids.

Use: As an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids; this drug does not eliminate glucocorticoid use.

You should not use avacopan if you are allergic to it or any of its inactive ingredients.

Tell your doctor if you have ever had:

• liver problems or abnormal liver function tests;

• hepatitis B or C; or

• if you currently have an infection.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. Talk to your doctor about the best way to feed your baby if you take avacopan.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Avacopan may cause serious side effects. Call your doctor at once if you have:

• signs of liver problems--loss of appetite, pain or swelling in your stomach, swelling in your legs, easy bleeding, drowsiness, confusion, or jaundice (yellowing of the skin or eyes); or

• signs of serious infections--fever, cold symptoms (runny nose or sore throat), flu symptoms (cough, tiredness, and body aches), earache or headache, painful urination, cold sores in mouth or throat.

Common side effects of avacopan may include:

• tiredness;

• rash;

• headache, dizziness;

• burning or prickling sensation;

• increase in blood creatinine;

• nausea, diarrhea, vomiting, stomach pain; or

• severe headache, blurred vision, pounding in your neck or ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect avacopan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.