Source: FDA, National Drug Code (US) Revision Year: 2023
SKYCLARYS is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
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)].
The recommended dosage of SKYCLARYS is 150 mg (3 capsules) taken orally once daily.
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.
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. |
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 |
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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