Skyclarys

Pronunciation: skye-klar-is
Generic name: omaveloxolone
Dosage form: capsules (50mg)
Drug class: Miscellaneous central nervous system agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 16, 2024.

What is Skyclarys?

Skyclarys (omaveloxolone) is a medication used for Friedreich's ataxia, to help slow the loss of strength and coordination and slow Friedreich's ataxia (FA) disease progression. Skyclary is thought to work (mechanism of action) by activating the Nrf2 pathway to reduce the inflammation, improve neurological function and slow disease progression. In Friedreich's ataxia a pathway called Nrf2 pathway is impaired, and Nrf2 activity is lower which results in damage to nerves. 

Skyclarys FDA approval was received on February 28, 2023, for the treatment of Friedreich's ataxia in patients 16 years and older.

Skyclarys capsules are taken once a day.

What is Friedreich's ataxia?

Friedreich's ataxia is a rare, inherited disease that causes progressive damage to the nervous system which causes poor muscle control and movement problems over time. This can affect walking and balance, hand coordination, speech, swallowing, eye movements, and eventually may result in patients requiring a wheelchair. FA may also affect the heart muscle and cause a type of heart disease called cardiomyopathy.

FA is caused by a faulty gene, called the frataxin gene (or FXN) which results in damage to nerve fibers in the spinal cord and peripheral nerves.

Skyclarys side effects

Common Skyclarys side effects may include nausea, stomach pain, diarrhea, abnormal lab tests, headache, tiredness, or muscle pain.

Serious Skyclarys side effects

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

This medicine may cause other serious side effects. Call your doctor at once if you have:

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

Your treatment with this medicine may be changed, delayed or permanently discontinued if you have certain side effects.

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.

Related/similar drugs

omaveloxolone

Before taking Skyclarys

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.

This medicine 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.

How should I take Skyclarys?

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

Dosing information

Usual Adult Skyclarys Dose for Friedreich's Ataxia:
Recommended dose: Take 150 mg (3 capsules) once daily on an empty stomach. 

Usual Pediatric Dose for Friedreich's Ataxia (adolescents aged 16 years and older):
Recommended dose: Take 150 mg (3 capsules) once daily on an empty stomach. 

Available as: Skyclarys 50mg capsules 

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking this medicine?

Do not drink grapefruit juice or eat grapefruit. These may change the amount of Skyclarys in your blood.

What other drugs will affect Skyclarys?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s Wort.

Taking Skyclarys with other medicines can cause serious side effects.

Skyclarys may affect the way other medicines work, and other medicines may affect how Skyclarys works.

Skyclarys is known to interact with moderate or strong CYP3A4 inhibitors including:

• antifungal medicines (itraconazole, ketoconazole, posaconazole, voriconazole)
• macrolide antibiotics (erythromycin, clarithromycin)
• antiretrovirals (atazanavir, darunavir, indinavir, nelfinavir, ritonavir, saquinavir, cobicistat)
• heart or blood pressure medicines (diltiazem, verapamil)
• nefazodone

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Skyclarys Prescribing Information 

Review the Skyclarys Prescribing Information for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep all medicines out of the reach of children and pets.

Ingredients 

Active ingredient: omaveloxolone
Inactive ingredients: croscarmellose sodium, magnesium stearate, pregelatinized starch, silicified microcrystalline cellulose. The hard capsule shells contain FD&C Blue #1, ferric oxide yellow, hypromellose, titanium dioxide, and white edible ink.

Company

Manufactured for Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen, Cambridge, MA 02142 USA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer