Recommended Evaluations Prior to Treatment Initiation

Before initiating TAVNEOS, consider performing the following evaluations:

• Liver Function Tests: Obtain liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TAVNEOS. TAVNEOS is not recommended for use in patients with cirrhosis, especially those with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)].
• Hepatitis B (HBV) Serology: Screen patients for HBV infection by measuring HBsAg and anti-HBc. For patients with evidence of prior or current HBV infection, consult with a physician with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before or during treatment with TAVNEOS [see Warnings and Precautions (5.3)].

Recommended Dosage and Administration

The recommended dose of TAVNEOS is 30 mg (three 10 mg capsules) twice daily, with food.

Advise patients that TAVNEOS capsules should not be crushed, chewed or opened.

If a dose is missed, instruct the patient to wait until the usual scheduled time to take the next regular dose. Instruct the patient not to double the next dose.

Dosage Modifications Due to CYP3A4 Inhibitors

Reduce the dosage of TAVNEOS to 30 mg once daily when used concomitantly with strong CYP3A4 inhibitors.