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omaveloxolone (Skyclarys)
Indications:
- treatment of Friedrich's ataxia in adults & adolescents >= 16 years
Contraindications:
- avoid in patients with severe hepatic impairment
- pregnancy: may cause fetal harm
Dosage:
- 150 mg (3 capsules) PO QD on empty stomach >= 1 hour prior to eating
- swallow capsules hole, do not crush or chew
- 100 mg PO QD for moderate hepatic impairment
- reduce dose to 50 mg PO QDif adverse effects emerge
* see Laboratory:
Laboratory:
- obtain liver function tests, serum BNP & lipid panel prior to initiation & during treatment with omaveloxolone
Adverse effects:
- >= 20%
- elevated serum ALT, serum AST
- headache, abdominal pain, musculoskeletal pain
- nausea, diarrhea
- fatigue
Drug interactions:
- moderate-strong CYP3A4 inhibitors
- moderate-strong CYP3A4 inducers
Mechanism of action:
- unknown
- activate Nrf2 pathway involved in response to oxidative stress
General
neurologic agent
Database Correlations
PUBCHEM correlations
References
- Highlights of Prescribing Information
Skyclarys (omaveloxolone) capsules, for oral use
https://s27.q4cdn.com/486207181/files/doc_downloads/2023/skyclarys_us_prescribing_information.pdf