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The following safety information highlights important risks and precautions associated with the use of Tavneos (avacopan). Please review these details carefully and discuss any concerns with your healthcare provider.

• Liver Health Risks: Tavneos (avacopan) may cause serious liver issues, potentially leading to liver failure or death. Regular blood tests will be necessary to monitor liver function before and during treatment. Seek immediate medical attention if you experience symptoms such as abdominal swelling, jaundice (yellowing of skin or eyes), changes in stool color (black, tarry, or bloody), vomiting, confusion, or abdominal pain. Discontinuation of the medication may be required to prevent further liver damage, especially if you have a history of liver problems.

• Allergic Reactions: Though rare, severe allergic reactions, including angioedema (swelling beneath the skin), can occur. Immediate medical attention is critical if you notice facial, mouth, or throat swelling, difficulty breathing, weakness, rash, or chest pain.

• Infection Risks: Tavneos (avacopan) has been associated with serious infections, such as pneumonia and urinary tract infections. A hepatitis B screening is necessary before commencing treatment. Contact your healthcare provider if you develop a fever or signs of infection, such as a cough, shortness of breath, weakness, chills, or sweating. Treatment may need to be paused to allow your body to combat the infection. If you have a history of hepatitis B or are currently infected, your provider will monitor you throughout the treatment and for six months following the last dose. Increased risk factors include active, chronic, or recurring infections, living or traveling in areas with high TB or fungal infection rates, and using medications that suppress the immune system.

There are no specific contraindications provided for Tavneos (avacopan). Always consult with your healthcare provider to ensure safe and effective use of this medication.

When taking this medication, some common side effects you might experience include nausea, headache, high blood pressure, diarrhea, vomiting, rash, and fatigue. These effects are generally mild, but if they persist or worsen, it is important to consult your healthcare provider. Other side effects that may occur include stomach pain, dizziness, and a "pins and needles" sensation. Although these are less common, they should still be monitored and discussed with your healthcare provider if they occur.

There are also rare but serious side effects associated with this medication that require immediate medical attention. These include signs of liver problems, such as persistent nausea or vomiting, loss of appetite, stomach pain, yellowing of the skin or eyes, and dark urine. Kidney issues may present as changes in urination. Be alert to symptoms of severe infections, such as a persistent sore throat, fever, cough, shortness of breath, or painful urination. Additionally, while rashes are common and often not serious, they can occasionally signify a severe reaction, so seek medical help if you develop any rash.

An allergic reaction to this medication is very rare but can be serious. Symptoms to watch for include rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, and trouble breathing. If you experience any of these, seek medical help immediately. Always stay informed about the side effects and communicate any concerns with your healthcare provider to ensure your safety while using this medication.