2.1 Recommended Testing Before Initiating SKYCLARYS and Monitoring to Assess Safety

Obtain ALT, AST, bilirubin, BNP, and lipid parameters prior to initiating SKYCLARYS and during treatment [see Warnings and Precautions (5.1, 5.2, 5.3)].

2.2 Recommended Dosage

The recommended dosage of SKYCLARYS is 150 mg (3 capsules) taken orally once daily.

• Administer SKYCLARYS on an empty stomach at least one hour before eating [see Clinical Pharmacology (12.3)].
  
• Swallow SKYCLARYS capsules whole. Do not open, crush, or chew.

2.3 Missed Doses

If a dose of SKYCLARYS is missed, take the next dose at its scheduled time the following day. A double dose should not be taken to make up for a missed dose.

2.4 Recommendations for Concomitant Use with Strong or Moderate CYP3A4 Inhibitors and Inducers

The recommended dosage for concomitant use of SKYCLARYS with cytochrome P450 (CYP) 3A4 inhibitors and inducers are described in Table 1 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Table 1: Recommended Dosage of SKYCLARYS with Concomitant Use of CYP3A4 Inhibitors and

Inducers

2.5 Recommended Dosage for Patients with Hepatic Impairment

The recommended dosage for patients with hepatic impairment are described in Table 2 [see Use in Specific Populations (8.6)].

Table 2: Recommended Dosage in Patients with Hepatic Impairment