Drug Detail:Skyclarys (Omaveloxolone)
Generic Name: OMAVELOXOLONE 50mg
Dosage Form: capsule
Drug Class: Miscellaneous central nervous system agents
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
Concomitant Drug Class | Dosage |
Strong CYP3A4 inhibitor | Recommended to avoid concomitant use. If coadministration cannot be avoided:
|
Moderate CYP3A4 inhibitor | Recommended to avoid concomitant use. If coadministration cannot be avoided:
|
Strong or Moderate CYP3A4 inducer | Recommended to avoid concomitant use. |
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
Impairment Classification (Child-Pugh) | Dosage |
Severe (Child-Pugh Class C) | Avoid use |
Moderate (Child-Pugh Class B) |
|
Mild (Child-Pugh Class A) | 150 mg once daily |