Skyclarys: Uses, Side Effects and Dosage

What SKYCLARYS is used for:

SKYCLARYS is used in adults and adolescents (16 years of age and older) to treat a rare, inherited disease called Friedreich’s ataxia. Friedreich’s ataxia causes gradual damage to the nervous system, which leads to movement problems.

How SKYCLARYS works:

It is not known exactly how SKYCLARYS works. However, it activates a protein complex in the body called “Nrf2”. This helps to protect cells in the body, especially those in the brain and nervous system, from damage.

The ingredients in SKYCLARYS are:

Medicinal ingredient: Omaveloxolone

Non-medicinal ingredients:

• Capsule contents: croscarmellose sodium, magnesium stearate, pregelatinized starch, and

  silicified microcrystalline cellulose (microcrystalline cellulose and silica, colloidal anhydrous).

• Capsule shell: brilliant blue FCF, ferric oxide yellow, hypromellose, and titanium

  dioxide.

• Printing ink: shellac and titanium dioxide.

SKYCLARYS comes in the following dosage form:

Capsules: 50 mg of omaveloxolone

Do not use SKYCLARYS if:

• you are allergic to omaveloxolone or to any of the other ingredients in SKYCLARYS.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SKYCLARYS. Talk about any health conditions or problems you may have, including if you:

• are taking other medicines before you start SKYCLARYS.
• have liver problems.

• are pregnant or plan to become pregnant. If you think you are pregnant while taking SKYCLARYS, tell your healthcare professional right away.

• are able to get pregnant and are using hormonal birth control methods (e.g., implants, progestin only pills, patches, or rings).
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into the breast milk.

Other warnings you should know about:

Check-ups and testing: Your healthcare professional will assess and monitor your health before and during your treatment with SKYCLARYS. This will depend on your health and may include tests to monitor the following:

• your liver;
• your heart;
• the profile of your blood;
• your weight; and/or
• signs of heart problems such as sudden weight gain, swelling of legs, ankles, or feet, or shortness of breath.

They may adjust or stop your treatment with SKYCLARYS depending on your results.

• Birth control: If you are taking any hormonal birth control, tell your healthcare professional. Your healthcare professional will direct you to use a different method of birth control without the use of hormones. This can include non-hormonal intrauterine device (IUD) or barrier contraceptives (e.g., condoms). A reliable method of birth control should be used during SKYCLARYS treatment and for 28 days after stopping treatment with SKYCLARYS. Talk to your healthcare professional about the most suitable birth control for you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SKYCLARYS:

• itraconazole, a medicine used to treat certain fungal infections.
• verapamil, a medicine used to treat high blood pressure.
• efavirenz, a medicine used to treat human immunodeficiency virus (HIV).
• midazolam, a medicine used to help with sleep or relaxation before and during surgeries or medical procedures.
• hormonal contraceptives, medicines that use hormones to prevent pregnancy (e.g., pill, patch, or ring).
• repaglinide, a medicine used to control blood sugar in people with type 2 diabetes.
• rosuvastatin, a medicine used to lower bad cholesterol in the blood.
• grapefruit or grapefruit juice.

These are some of the medicines that may interact. Let your healthcare professional know if you are taking any other medicines before you start SKYCLARYS.

How to take SKYCLARYS:

• Take SKYCLARYS exactly as your healthcare professional has told you. If you are unsure, check with your healthcare professional.

• SKYCLARYS must be taken orally on an empty stomach at least one hour before or two hours after eating. Swallow your capsules whole with a glass of water. Do not crush or chew the capsules.

• Take the capsules at about the same time during the day.
• Avoid grapefruit and grapefruit juice while taking SKYCLARYS.

• If you are unable to swallow the capsules whole:

  • Talk to your healthcare professional.
  • Your healthcare professional may direct you to open the capsules and sprinkle the entire contents onto 2 tablespoons (30 mL) of applesauce. You must eat all the applesauce/medicine mixture immediately after making it. Do not store the applesauce/medicine mixture for future use.
  • The contents of the SKYCLARYS capsules should not be mixed with milk or orange juice.

Usual dose:

Your healthcare professional will decide the right dose for you. This will depend on your condition, health, other medicines you take, and how you respond to SKYCLARYS. The usual dose is 150 mg (3 capsules) once per day.

Overdose:

If you think you, or a person you are caring for, have taken too much SKYCLARYS, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss or forget to take a dose of SKYCLARYS, skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for a forgotten dose.

Possible side effects from using SKYCLARYS:

These are not all the possible side effects you may have when taking SKYCLARYS. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of SKYCLARYS include:

• headache
• nausea
• fatigue
• rash
• drowsiness or sleepiness
• diarrhea
• abdominal pain
• indigestion or stomach discomfort
• feeling bloated
• constipation
• decreased appetite
• decrease in weight

SKYCLARYS can cause increases to liver enzymes and cholesterol levels. Your healthcare professional will decide when to perform the tests and interpret the results.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or

  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store SKYCLARYS capsules at room temperature (15°C to 30°C).
• Do not use this medicine after the expiry date which is stated on the bottle and carton after the letters “EXP”. The expiry date refers to the last date of that month.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
• Keep this medicine out of the sight and reach of children.

If you want more information about SKYCLARYS:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.biogen.ca/products/SKYCLARYS_PM_EN, or by calling 1-833-284-0651.

Date of Authorization: MAR 13, 2025

Date of Revision: MAR 6, 2026