Omaveloxolone

Generic name: Omaveloxolone
Brand names: Skyclarys
Dosage form: oral capsule (50 mg)
Drug class: Miscellaneous central nervous system agents

Usage of Omaveloxolone

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.

Omaveloxolone side effects

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.

Before taking Omaveloxolone

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.

Relate drugs

How to use Omaveloxolone

Usual Adult Dose for Friedreich's Ataxia:

Recommended dose: 150 mg orally on an empty stomach once dailyUse: 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 dailyUse: For the treatment of adolescents aged 16 years and older with Friedreich's ataxia.

Warnings

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

What other drugs will affect Omaveloxolone

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.

Disclaimer

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