Recommended Dosage

The recommended dose of ELYXYB is 120 mg taken orally, with or without food [see Clinical Pharmacology (12.3)].

The maximum dosage in a 24-hour period is 120 mg. The safety and effectiveness of a second dose in a 24-hour period have not been established.

Use ELYXYB for the fewest number of days per month, as needed.

Dosage Modification in Patients with Hepatic Impairment

The recommended and maximum dose in patients with moderate hepatic impairment (Child-Pugh Class B) is 60 mg (2.4 mL) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Use of ELYXYB in patients with severe hepatic impairment is not recommended.

Dosage Modification in CYP2C9 Poor Metabolizers

The recommended and maximum dose in patients who are known or suspected to be CYP2C9 poor metabolizers is 60 mg (2.4 mL) [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.5)]. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.