Avacopan

Avacopan is a prescription medication used for the treatment of antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis.

• Avacopan is available under various brand names: Tavneos

Common side effects of Avacopan include:

• nausea, 
• diarrhea, 
• tiredness, 
• headache, 
• vomiting, 
• stomach pain, 
• high blood pressure, 
• rash, 
• dizziness, 
• burning or prickling sensation, 
• nausea, 
• chest pain, 
• muscle cramp, 
• vomiting, 
• fatigue, 
• swelling or fluid retention, and
• high blood pressure

Serious side effects of Avacopan include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe dizziness, 
• trouble swallowing, 
• chest pain, 
• dizziness, 
• fainting, 
• severe abdominal pain, 
• vomiting, 
• fever, 
• runny nose, 
• sore throat, 
• cough, 
• tiredness, 
• body aches, 
• earache, 
• headache, 
• pain during urination, 
• cold sores, and
• red, warm, swollen or painful skin

Rare side effects of Avacopan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 10 mg

ANCA–associated Vasculitis

Adult dosage

• 30 mg orally twice daily with food

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Avacopan has severe interactions with the following drug:
  • upadacitinib
• Avacopan has serious interactions with no other drugs.
• Avacopan has moderate interactions with no other drugs.
• Avacopan has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to avacopan or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Avacopan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Avacopan?”

Cautions

• May cause angioedema; if angioedema occurs, discontinue avacopan immediately, provide appropriate therapy, and monitor for airway compromise; do not readminister unless another cause has been established
• Serious infection
  • Serious infections, including fatal infections, reported; common infections reported included pneumonia and urinary tract infections
  • Avoid use with active, serious infection, including localized infections
  • Closely monitor for signs and symptoms of infection during and after treatment; interrupt treatment if a serious or opportunistic infection develops
  • If a new infection develops during treatment, promptly complete diagnostic testing appropriate for an immunocompromised patient; initiate appropriate antimicrobial therapy and closely monitor
  • Interrupt treatment if unresponsive to antimicrobial therapy; may resume once infection controlled
  • Consider risks and benefits before initiating in patients
  • With chronic or recurrent infection
  • Who have been exposed to tuberculosis
  • With history of serious or opportunistic infection
  • Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses
  • With underlying conditions that may predispose them to infection
• HBV reactivation
  • Hepatitis B virus (HBV) reactivation, including life-threatening hepatitis B, observed during clinical trials
  • Reactivation of HBV replication is often followed by hepatitis; in severe cases, increase in bilirubin levels, liver failure, and death can occur
  • Screen patients for HBV infection by measuring HBsAg and anti-HBc before initiating
  • Refer to specialist if patient shows evidence of prior HBV infection to consider HBV antiviral therapy before and/or during avacopan treatment
  • Insufficient data exist regarding safety of resuming avacopan in patients who develop HBV reactivation; consult specialist regarding resumption in patients whose HBV reactivation resolves
• Hepatotoxicity
  • Serious cases of hepatic injury observed; monitor closely for hepatic adverse reactions
  • During controlled trials, a higher incidence of transaminase elevations and hepatobiliary events, including serious and life-threatening events, were reported
  • Monitor liver enzymes before and during treatment
  • ALT or AST above 3x ULN: Evaluate promptly and consider pausing treatment as clinically indicated
  • AST or ALT above 5x ULN or AST or ALT above 3x ULN with bilirubin above 2x ULN: Discontinue until avacopan-induced liver injury is ruled out
  • Not recommended with active, untreated, and/or uncontrolled chronic liver disease (eg, chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis
• Drug interaction overview
• CYP3A4 substrate (major); shows induction and time-dependent inhibition of CYP3A4
• Strong CYP3A4 inhibitors
  • Decrease avacopan dose
  • Coadministration with strong CYP3A4 inhibitor increases avacopan systemic exposure
  • Moderate and strong CYP3A4 inducers
  • Avoid coadministration
  • Coadministration with moderate or strong CYP3A4 inducers decreases avacopan systemic exposure
• CYP3A4 substrates
  • Closely monitor CYP3A4 substrates with a narrow therapeutic window; consider dose reduction
  • Avacopan inhibits CYP3A4 substrates

Pregnancy & Lactation

• There are no adequate and well-controlled studies in pregnant females to inform a drug-associated risk
• Increased number of spontaneous abortions in rabbits observed
• Lactation
  • Data are not available on secretion in human milk, effects on breastfed children, or on milk production
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for avacopan and any potential adverse effects on the breastfed infant from avacopan or from the underlying maternal condition