Avacopan Oral Capsules

What is this medication?

AVACOPAN (a va koe pan) is a complement receptor inhibitor. It is used to treat vasculitis, such as granulomatosis with polyangiitis and microscopic polyangiitis. It is used with other medicines, such as steroids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TAVNEOS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• immune system problems
• infection such as tuberculosis (TB) or other bacterial, fungal or viral infections
• liver disease
• an unusual or allergic reaction to avacopan, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. Take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like itraconazole, ketoconazole, posaconazole, or voriconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• clarithromycin
• midazolam
• nefazodone
• rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• pain, tingling, numbness in the hands or feet
• trouble breathing or swallowing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• headache
• nausea
• vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 to 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.