What is the most important information I should know about avacopan?
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).
What is avacopan?
Avacopan is used with other medicines (including glucocorticoids) to treat adults with granulomatosis with polyangiitis (previously known as Wegener's granulomatosis). This medicine is also used to treat adults with microscopic polyangiitis.
Avacopan may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking avacopan?
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.
How should I take avacopan?
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 this medicine 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.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking avacopan?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of avacopan?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
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 may include:
- 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.
What other drugs will affect avacopan?
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.
Where can I get more information?
Your doctor or pharmacist can provide more information about avacopan.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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