Formulary
Omaveloxolone: Indications, Dosing, Side Effects and Interactions
Omaveloxolone activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, although it's exact mechanism of action is unknown.
MedNext Academy | 3 min read
Omaveloxolone: Indications, Dosing, Side Effects and Interactions
Omaveloxolone activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, although it's exact mechanism of action is unknown.
Drug action
Omaveloxolone activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, although it's exact mechanism of action is unknown.
Indications and dose
**Friedreich's ataxia (under expert supervision)**
- **Adult** (By Mouth): 150 mg once daily.
**Friedreich's ataxia (under expert supervision) for omaveloxolone**
- **Child 16-17 years** (By mouth): 150 mg once daily.
Side effects
Common or very common Appetite decreased; back pain; diarrhoea; dyslipidaemia; dysmenorrhoea; fatigue; gastrointestinal discomfort; headache; increased risk of infection; muscle spasms; nausea; oropharyngeal pain; vomiting; weight decreased
Interactions
**Other interactions (11):**
- Omaveloxolone is a substrate of CYP3A4.
- Co-administration of strong or moderate CYP3A4 inhibitors or CYP3A4 inducers will affect the pharmacokinetics of omaveloxolone.
- Effect of other medicines on pharmacokinetics of omaveloxolone Strong or moderate CYP3A4 inhibitors In a clinical study, co-administration of Skyclarys with itraconazole, a strong CYP3A4 inhibitor,...
- Verapamil is a known moderate CYP3A4 inhibitor and inhibitor of the P-gp transporter.
- Some examples of strong and moderate CYP3A4 inhibitors are clarithromycin, itraconazole, ketoconazole, ciprofloxacin, cyclosporine, fluconazole, and fluvoxamine.
- As grapefruit and grapefruit juice are inhibitors of CYP3A4, patients should be warned to avoid these while taking Skyclarys (see section 4.4).
Pregnancy
Avoid (toxicity in animal studies). M
Breast feeding
Specialist sources indicate use with caution, especially if breast-feeding a neonate or preterm infant (no information available). High plasma-protein binding suggests limited excretion into milk .
Hepatic impairment
Caution in moderate impairment (risk of increased exposure); avoid in severe impairment (limited information available). M Dose adjustments Reduce dose to 100 mg once daily in moderate impairment; consider further dose reduction to 50 mg once daily if side-effects occur. M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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