Tavneos

About Avacopan

• Avacopan, marketed under the brand name Tavneos, is a medication utilized for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis. Tavneos does not replace the need for glucocorticoid use.
• Avacopan functions as a complement 5a receptor antagonist and a cytochrome P450 3A4 inhibitor, Avacopan gained approval for medical use in Japan in September 2021 and the United States in October 2021. 
• Notably, it is the inaugural orally-administered inhibitor of the complement C5a receptor sanctioned by the US Food and Drug Administration (FDA), marking it as a first-in-class medication. 
• Tavneos’ active component, avacopan, obstructs the receptor for complement 5a, a protein in the blood integral to the immune system.

Strength: 

Tavneos capsule is available in 10 mg capsules. 

Recommended Dosage:

Before initiating Tavneos, it is essential to conduct necessary evaluations. Obtain a liver function test panel, including ALT, AST, alkaline phosphatase, and total bilirubin, as Tavneos is not recommended for patients with cirrhosis, especially those with severe hepatic impairment (Child-Pugh C). Additionally, screen patients for hepatitis B (HBV) infection by measuring HBsAg and anti-HBc. In cases of prior or current HBV infection, consult with a specialist in managing hepatitis B for monitoring and potential consideration of HBV antiviral therapy before or during Tavneos treatment.

• The suggested dosage for Tavneos is 30 mg, equivalent to three 10 mg capsules, administered twice daily with food. 
• Patients should be cautioned against crushing, chewing, or opening the Tavneos capsules. 
• In the event of a missed dose, advise patients to wait until the next regularly scheduled time for their next dose and explicitly instruct them not to double the subsequent dose.

Important:

Before commencing Tavneos treatment, promptly inform your doctor of any adverse reactions. If you notice unusual symptoms during treatment, consult your doctor immediately. Disclose pre-existing health conditions before starting the treatment, providing comprehensive information for safe administration. Open communication about your health is vital for personalized care and addressing concerns during the treatment process.

Warnings & Precautions

• Do not take Tavneos 10 mg if you are allergic to Avacopan or any of its ingredients. 
• Hepatotoxicity, characterized by an increase in liver function tests, was observed in clinical trials of Tavneos. 
• It is essential to conduct liver function tests before initiating therapy and continue monitoring as clinically indicated. 
• Serious hypersensitivity reactions, specifically cases of angioedema, were reported in a clinical trial, necessitating vigilant observation for signs and symptoms of angioedema with appropriate management. 
• Additionally, cases of Hepatitis B Virus (HBV) reactivation occurred, prompting the recommendation to withhold Tavneos and initiate suitable anti-infective therapy.
• Caution is advised against the use of Tavneos in patients with active, serious infections, including localized infections. 
• Regarding enzyme interactions, avoid Tavneos use with strong and moderate CYP3A4 enzyme inducers. In the case of strong CYP3A4 enzyme inhibitors, reduce the avacopan dose to 30 mg once daily. 
• For sensitive CYP3A4 substrates, monitor for adverse reactions and contemplate dose reduction for substrates with a narrow therapeutic window.

Common Tavneos Side Effects:

• Nausea
• Headache
• Hypertension
• Diarrhea
• Vomiting
• Rash
• Fatigue
• Upper abdominal pain
• Dizziness
• Blood creatinine increased
• Paresthesia (Burning or tingling sensations)
• Liver damage (mild, typically monitored through blood tests)
• Increased blood creatinine (an indicator of kidney function)
• Skin rash

Use in Specific Population

• There is a lack of adequate and well-controlled studies with Tavneos in pregnant women, preventing the determination of drug-associated risks. 
• Data on the effects of Avacopan on the breastfed child or milk production are currently unavailable. 
• The safety and effectiveness of Tavneos in pediatric patients remain undetermined, and there were no discernible differences in safety or effectiveness between geriatric and younger patients. 
• No dose adjustments are necessary for patients with mild, moderate, or severe renal impairment. 
• Tavneos has not undergone studies in ANCA-associated vasculitis patients on dialysis. 
• No dosage adjustment is advised for patients with mild or moderate hepatic impairment, as determined by the Child-Pugh method. However, it’s important to note that Tavneos has not undergone specific studies in patients with severe hepatic impairment.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze the medicine. Keep the medicine away from pets and children.