Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Reata Ireland Limited, Block A, Georges Quay Plaza, Georges Quay, Dublin 2, D02 E440 Ireland
Skyclarys is indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Omaveloxolone should be initiated and supervised by physicians with experience in the treatment of patients with Friedreich Ataxia.
The recommended dose is 150 mg omaveloxolone (3 hard capsules of 50 mg each) once daily.
Medicine lost through emesis should not be replaced with an additional dose.
If a dose is missed, the next dose should be taken as usual the following day. A double dose should not be taken to make up for a missed dose.
The recommended dosages for concomitant use of omaveloxolone with strong or moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers are described in Table 1 (see sections 4.4 and 4.5).
Table 1. Recommended dosage modifications of omaveloxolone with concomitant use of CYP3A4 inhibitors:
| Concomitant Drug Class | Dosage Recommendation |
|---|---|
| Strong CYP3A4 inhibitor | Recommended to avoid concomitant use. If coadministration cannot be avoided: • Reduce the dosage of Skyclarys to 50 mg |
| 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. |
No dose adjustment is required based on age (see section 5.2).
No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh Class A).
The dose should be reduced to 100 mg once daily with close monitoring for adverse reactions in patients with moderate hepatic impairment (Child-Pugh Class B). Lowering to 50 mg once daily should be considered if adverse reactions emerge.
The use of the medicinal product should be avoided in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
The effect of moderate and severe renal impairment on the pharmacokinetics of omaveloxolone has not been studied (see section 5.2).
The safety and efficacy of Skyclarys in children and adolescents aged less than 16 years have not yet been established. No data are available.
This medicinal product is for oral use.
Omaveloxolone should be taken on an empty stomach at least 1 hour before or 2 hours after eating (see sections 4.5 and 5.2).
Skyclarys capsules should be swallowed whole.
For patients who are unable to swallow whole capsules, Skyclarys capsules may be opened, and the entire contents sprinkled onto 2 tablespoons of apple puree. Patients should consume all the medicine/food mixture immediately on an empty stomach at least 1 hour before or 2 hours after eating. It should not be stored for future use (see section 5.2).
There is no specific antidote for Skyclarys. For patients who experience overdose, closely monitor and provide appropriate supportive treatment.
4 years.
This medicinal product does not require any special storage conditions.
High density polyethylene bottles with child-resistant, foil induction-sealed polypropylene closure.
Pack size of 90 capsules.
Pack size of 270 (3 packs of 90) capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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