Skyclarys Dosage

Generic name: omaveloxolone 50mg
Dosage form: capsule
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Drugs.com. Last updated on Jan 30, 2024.

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)].

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 crush or chew.
For patients who are unable to swallow whole capsules:
- SKYCLARYS capsules may be opened and the entire contents of both halves of the capsule sprinkled onto 2 tablespoons (30 mL) of applesauce [see Clinical Pharmacology (12.3)].
- Stir the mixture until homogenous.
- Swallow all the drug/applesauce mixture immediately.
- Do not store the mixture for future use.
- Contents of the SKYCLARYS capsules should not be mixed with milk or orange juice.
- Not for enteral feeding tube administration.

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.

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: Reduce the dosage of SKYCLARYS to 50 mg once daily with close monitoring for adverse reactions. If adverse reactions emerge, coadministration with strong CYP3A4 inhibitors should be discontinued.
Moderate CYP3A4 inhibitor	Recommended to avoid concomitant use. If coadministration cannot be avoided: Reduce the dosage of SKYCLARYS to 100 mg once daily with close monitoring for adverse reactions. If adverse reactions emerge, further reduce the dosage of SKYCLARYS to 50 mg once daily.
Strong or Moderate CYP3A4 inducer	Recommended to avoid concomitant use.

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)	100 mg once daily with close monitoring for adverse reactions Consider lowering to 50 mg once daily if adverse reactions emerge
Mild (Child-Pugh Class A)	150 mg once daily