Omaveloxolone

What is Omaveloxolone?

• Omaveloxolone (Skyclarys), a member of the synthetic oleanane triterpenoid class of compounds and an activator of nuclear factor erythroid 2 [NF-E2]-related factor 2 (Nrf2, Nfe2l2), with potential chemopreventive activity.

Omaveloxolone

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Omaveloxolone structure

What are the uses of this medicine?

• Omaveloxolone (Skyclarys) is used for the treatment of Friedreich's ataxia in adults and children 16 years of age and older.

How does this medicine work?

• The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown.
• Omaveloxolone have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
• The Nrf2 pathway is involved in the cellular response to oxidative stress.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider, 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.

Be sure to mention any of the following:

• CYP3A4 Inhibitors
• CYP3A4 Inducers

• Concomitant use with Skyclarys may reduce the efficacy of hormonal contraceptives. Advise patients to avoid concomitant use with combined hormonal contraceptives (e.g., pill, patch, ring), implants, and progestin only pills.

Is this medicine FDA approved?

• Omaveloxolone was approved for medical use in the United States in February 2023.

How should this medicine be used?

• Obtain ALT, AST, bilirubin, BNP, and lipid parameters prior to initiating Skyclarys and during treatment.

Recommended dosage:

• The recommended dosage of Skyclarys is 150 mg (3 capsules) taken orally once daily.
• If a dose of Skyclarys is missed, take the next dose at its scheduled time the following day. A double dose should not be taken to make up for a missed dose.

With Strong CYP3A4 inhibitor:

• If coadministration cannot be avoided:
• Reduce the dosage of Skyclarys to 50 mg once daily with close monitoring for adverse reactions.
• If adverse reactions emerge, coadministration with strong CYP3A4 inhibitors should be discontinued.

With Moderate CYP3A4 inhibitor:

• If coadministration cannot be avoided:
• Reduce the dosage of Skyclarys to 100 mg once daily with close monitoring for adverse reactions.
• If adverse reactions emerge, further reduce the dosage of Skyclarys to 50 mg once daily.

With Strong or Moderate CYP3A4 inducer:

• Recommended to avoid concomitant use.

Administration:

• Take Skyclarys exactly as your healthcare provider tells you to take it.
• Take Skyclarys capsules on an empty stomach at least 1 hour before eating.
• Swallow Skyclarys capsules whole. Do not open, crush, or chew.
• If you miss a dose, then you should skip the missed dose and take the next dose at the regular time the next day. Do not double your next dose or take more than the prescribed dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Capsules: 50 mg

This medicine is available in fallowing brand namesː

• Skyclarys

What side effects can this medication cause?

The most common side effects of this medicine include:

• increased liver enzymes (ALT/AST)
• headache
• nausea
• stomach pain
• tiredness
• diarrhea
• muscle pain

Less common, but serious side effects may include:

• increase in blood liver enzymes
• increase in a blood protein called B-Type Natriuretic Peptide (BNP)
• changes in cholesterol levels

What special precautions should I follow?

• Treatment with Skyclarys can cause an elevation in hepatic transaminases (ALT and AST). Inform patients that elevation in aminotransferases have occurred in patients treated with Skyclarys. Liver function tests will be performed prior to initiating Skyclarys, every month for the first 3 months of treatment, and periodically thereafter as needed.
• Inform patients that elevations in BNP, a marker of cardiac function, have occurred in patients treated with Skyclarys. BNP will be performed prior to initiating Skyclarys and if signs and symptoms of fluid overload occur, such as sudden weight gain, peripheral edema, palpitations, and shortness of breath. Advise patients to contact their healthcare provider if signs and symptoms of fluid overload develop.
• Treatment with Skyclarys can cause changes in cholesterol. Inform patients that treatment with Skyclarys has been associated with increases in LDL cholesterol and decreases in HDL cholesterol. Cholesterol will be assessed prior to starting Skyclarys and monitored periodically during treatment.
• Counsel females using hormonal contraceptives to use an alternative contraceptive method (e.g., non-hormonal intrauterine system) or additional non-hormonal contraceptive (e.g., condoms) during concomitant use and for 28 days after discontinuation of Skyclarys.
• Advise patients to avoid grapefruit juice and grapefruit while they are taking Skyclarys.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Skyclarys will harm your unborn baby.
• Women who use hormonal birth control should use another form of birth control such as a non-hormonal intrauterine system or an extra non-hormonal birth control such as condoms while using Skyclarys and for 28 days after stopping Skyclarys.

Can this medicine be used in children?

• It is not known if Skyclarys is safe and effective for use in children younger than 16 years of age.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Manufactured for Reata Pharmaceuticals, Inc., Plano, TX USA

• Skyclarys is a trademark of Reata Pharmaceuticals Holdings, LLC.

What should I know about storage and disposal of this medication?

• Store Skyclarys at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Omaveloxolone
• FDA Omaveloxolone

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