Omaveloxolone Dosage

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

Applies to the following strengths: 50 mg

Usual Adult Dose for Friedreich's Ataxia

Recommended dose: 150 mg orally on an empty stomach once daily

Use: For the treatment of adult patients with Friedreich's ataxia.

Usual Pediatric Dose for Friedreich's Ataxia

Recommended dose: 150 mg orally on an empty stomach once daily

Use: For the treatment of adolescents aged 16 years and older with Friedreich's ataxia.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh Class A): 150 mg orally once daily
Moderate liver dysfunction (Child-Pugh Class B): 100 mg orally once daily with close monitoring for adverse reactions. Consider lowering to 50 mg orally once daily if adverse reactions emerge.
Severe liver dysfunction (Child-Pugh Class C): Avoid use.

Dose Adjustments

Concomitant use with Strong CYP450 3A4 Inhibitors:

Recommended to avoid concomitant use.
If coadministration is unavoidable:
Decrease dosage to 50 mg orally once daily with close monitoring for adverse reactions.
If adverse reactions emerge, coadministration with strong CYP450 3A4 inhibitors should be discontinued.

Concomitant use with Moderate CYP450 3A4 Inhibitors:

Recommended to avoid concomitant use.
If coadministration is unavoidable:
Decrease dosage to 100 mg orally once daily with close monitoring for adverse reactions.
If adverse reactions emerge, decrease dosage again to 50 mg orally once daily.

Concomitant use with Strong or Moderate CYP450 3A4 Inducers:

Recommended to avoid concomitant use.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Obtain aspartate aminotransferase (AST), alanine transaminase (ALT), bilirubin, B-type natriuretic peptide (BNP), and lipid parameters before initiating this drug and during treatment. Liver function tests should be performed every month for the first three months of treatment, and periodically.
Should be taken orally on an empty stomach at least one hour before a meal.
Swallow capsules whole. Do not open, crush, or chew.
Advice female patients on hormonal contraceptives to use alternative or additional non-hormonal methods while on treatment and for 28 days after discontinuation.

Storage requirements:

Store at 20C to 25C (68F to 77F), excursions permitted between 15C to 30C (59F to 86F).

Monitoring:

Cardiac: BNP (prior to and during therapy if signs and symptoms of fluid overload occur)
Hepatic: Liver function (prior to and during therapy)
Lipid Panel (prior to and during therapy)

General:

Safety and efficacy have not been established in older adults aged 65 and above.

Patient advice:

Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Report all new or worsening symptoms to a healthcare provider.
Female patients should notify their healthcare provider if pregnant or intend to get pregnant while on this medication.
This drug has the potential to interact with other drugs. Discuss all medications with your healthcare provider, including birth control, over-the-counter and herbal drugs.