How should I take AVACOPAN capsules?

You should take 30 mg (three 10 mg capsules) twice daily with food. Do not crush, chew, or open the capsules.

Can I take TAVNEOS if I have liver problems?

TAVNEOS is not recommended for patients with cirrhosis or severe liver impairment.

What should I do if I miss a dose of AVACOPAN?

Wait until your next scheduled time to take the regular dose; do not take two doses at once to make up for a missed one.

Does TAVNEOS cause liver damage?

Yes, increased liver function tests and serious liver injury have been observed in clinical trials, so regular monitoring is required.

Can TAVNEOS reactivate Hepatitis B?

Yes, cases of Hepatitis B virus reactivation have occurred in clinical trials.

What are the common side effects of AVACOPAN?

Common side effects include nausea, headache, high blood pressure, diarrhea, vomiting, and fatigue.

Is TAVNEOS safe to take during pregnancy?

There are no adequate studies in pregnant women, though animal studies showed some risks of fetal harm at certain exposure levels.

Can I take simvastatin with TAVNEOS?

If you take simvastatin with TAVNEOS, you should limit your simvastatin dose to 10 mg daily.

How should I store TAVNEOS capsules?

Store them at room temperature between 68°F to 77°F (20°C to 25°C). Do not use if the seal is broken.

avacopan | CAS 1346623-17-3 | PUKBOVABABRILL

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Complement 5a receptor (C5aR) antagonist

AVACOPAN (brand name TAVNEOS) is an oral capsule used as an extra treatment for adults with severe active ANCA-associated vasculitis (specifically GPA and MPA) alongside standard therapies like glucocorticoids. It works by blocking a specific receptor (C5aR) to stop certain immune cells from causing inflammation.

How it worksAVACOPAN works by blocking the interaction between the C5a receptor and the C5a protein, which stops immune cells (neutrophils) from becoming active and moving to sites of inflammation.

Brand names:TAVNEOS

Used for

Severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitisGranulomatosis with polyangiitis (GPA)Microscopic polyangiitis (MPA)

Conditions

ANCA-associated vasculitis

Class

C5aR antagonistComplement inhibitorComplement 5a receptor (C5aR) antagonistImmune SystemVascular System

How to take

FormsOral capsule

RoutesOral

The usual dose is 30 mg (three 10 mg capsules) taken twice daily with food.

Do not crush, chew, or open the capsules. If you miss a dose, wait until your next scheduled time and do not double up.

Missed dose: If you miss a dose, wait until your next scheduled time to take it. Do not double the dose.

Key warnings

·Liver health: AVACOPAN can cause liver problems. Doctors will check your liver function before starting and regularly during treatment.
·Allergic reactions: Some people may experience severe swelling (angioedema).
·Hepatitis B: The drug may cause a reactivation of Hepatitis B in some patients.
·Infections: Avoid using AVACOPAN if you have an active, serious infection.

Do not use if

·People with a serious hypersensitivity (allergic) reaction to avacopan or any of its ingredients.

Side effects

Common

NauseaHeadacheHigh blood pressureDiarrheaVomitingRashFatigueUpper abdominal painDizzinessIncreased blood creatinineParesthesia (tingling sensation)

Serious

·Liver injury (hepatotoxicity)
·Severe allergic reactions (angioedema)
·Hepatitis B virus (HBV) reactivation
·Serious infections

Seek help if

·Signs of swelling (angioedema)
·Yellowing of eyes or skin (jaundice)
·Severe abdominal pain
·Symptoms of infection

Interactions

·Avoid using AVACOPAN with strong or moderate CYP3A4 enzyme inducers like rifampin.
·If taking strong CYP3A4 inhibitors (like itraconazole), the dose of AVACOPAN should be reduced to 30 mg once daily.
·When taking AVACOPAN, limit simvastatin doses to 10 mg daily (or 20 mg for those previously tolerant of higher doses) because AVACOPAN can increase simvastatin levels.
·Known interactions include ZOCOR, ONMEL, and RIFADIN.

FoodTaking AVACOPAN with a high-fat, high-calorie meal increases how much medicine is in your body and delays how quickly it works.

Special populations

PregnancyThere are no well-controlled studies on AVACOPAN in pregnant women. In animal studies, high doses caused an increase in abortions in rabbits.

PediatricThe safety and effectiveness of TAVNEOS in children have not been established.

GeriatricSafety and effectiveness in elderly patients were similar to those seen in younger patients in clinical trials.

Talk to your doctor

Monitor

·Liver function (ALT, AST, alkaline phosphatase, total bilirubin)
·Signs of swelling or allergic reaction (angioedema)
·Symptoms of Hepatitis B reactivation

Questions to ask

·Should I have my liver checked regularly while taking TAVNEOS?
·Do I need to be screened for Hepatitis B before starting?
·How will TAVNEOS interact with my current medications?
·Can I take this if I have a history of liver issues?

Pharmacokinetics

BioavailabilityCo-administration with a high-fat, high-calorie meal increases exposure (AUC) by about 72%.

MetabolismInvolves CYP3A4 enzyme pathway.

Practical

StorageStore at room temperature between 68°F and 77°F. Do not use if the seal is broken.

Ingredients

Allergens

gelatin

Inactive

Polyethylene glycol 4000 (PEG-4000)Polyoxyl 40 hydrogenated castor oilGelatinRed iron oxideYellow iron oxideTitanium dioxidePolysorbate 80

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.