Omaveloxolone is used for the treatment of Friedreich's ataxia in adults and teenagers 16 years and older.

Omaveloxolone may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have swelling, rapid weight gain, or feeling short of breath.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take omaveloxolone on an empty stomach, at least 1 hour before a meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

Your blood will need to be tested often.

Store at room temperature away from moisture and heat.

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.

Tell your doctor if you have or have ever had:

• heart failure or other heart problems;

• high cholesterol; or

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Omaveloxolone can make hormonal contraceptives less effective. If you use hormonal birth control, ask your doctor about alternative birth control options such as condom or non-hormonal intrauterine device while using omaveloxolone and for at least 28 days after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with omaveloxolone and cause side effects. Avoid consuming grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Omaveloxolone may cause serious side effects. Call your doctor at once if you have:

• heart problems--swelling, rapid weight gain, feeling short of breath.

Your omaveloxolone treatments may be changed, delayed or permanently discontinued if you have certain side effects.

Common side effects of omaveloxolone may include:

• nausea, stomach pain, diarrhea;

• abnormal lab tests;

• headache;

• tiredness; or

• muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can affect omaveloxolone, especially:

• nefazodone;

• St. John's wort;

• an antibiotic--clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;

• antifungal medicine--itraconazole, ketoconazole;

• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir;

• cancer medicine--apalutamide, enzalutamide, mitotane;

• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone; or

• steroid medicine--dexamethasone, prednisone.

This list is not complete and many other drugs may affect omaveloxolone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.