SKYCLARYS

OMAVELOXOLONE

Manufacturer: Reata Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

SKYCLARYS (OMAVELOXOLONE) is a medication used for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. The recommended dosage is 150 mg once daily, and it should be administered on an empty stomach at least 1 hour before eating. The medication has shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in the cellular response to oxidative stress. However, the precise mechanism by which omaveloxolone exerts its therapeutic effect is unknown. SKYCLARYS has been associated with several adverse reactions, including elevated liver enzymes, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain. It is essential to monitor patients for these adverse reactions and adjust the dosage accordingly. Additionally, SKYCLARYS has several drug interactions, including moderate or strong CYP3A4 inhibitors and inducers, which may affect its efficacy and safety.

Key Clinical Findings and Indications

SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older
The medication activates the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway
The precise mechanism by which omaveloxolone exerts its therapeutic effect is unknown

Important Safety Information

Warning

SKYCLARYS has been associated with elevated liver enzymes, and patients should be monitored for this adverse reaction

Contraindications

Adverse Reactions

Elevated liver enzymes
Headache
Nausea
Abdominal pain
Fatigue
Diarrhea
Musculoskeletal pain

Dosing Recommendations

General Guidance

Dosage adjustments may be necessary for patients with moderate or severe hepatic impairment

Friedreich's ataxia

Adult Dose

150 mg once daily

Pediatric Dose

150 mg once daily for patients aged 16 years and older

Special Population Considerations

Pregnancy

There are no adequate data on the developmental risks associated with the use of SKYCLARYS in pregnant women
Animal studies have shown evidence of developmental toxicity

Nursing Mothers

Pediatric Use

The safety and effectiveness of SKYCLARYS have been established in pediatric patients aged 16 years and older
Use of SKYCLARYS in pediatric patients less than 16 years of age has not been established

Geriatric Use

Clinical studies of SKYCLARYS did not include patients aged 65 and over
No data are available to determine whether geriatric patients respond differently than younger adult patients

Similarity: 60.5%

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