6 mins read

Uses

What is Skyclarys used for?

Skyclarys (omaveloxolone) is commonly used to treat Friedreich’s ataxia. Friedreich’s ataxia is a rare, inherited disease that causes nervous system damage and muscle impairment. This causes difficulty walking, poor balance, impaired coordination, and changes in speech and swallowing. While Skyclarys does not cure Friedreich’s ataxia, it helps to slow the progression of the disease.

Learn more about Skyclarys for Friedreich Ataxia in Adults.

Skyclarys may also be used for other conditions as determined by your healthcare provider.

How does Skyclarys work (mechanism of action)?

The exact way that Skyclarys works for Friedreich’s ataxia is not known. It is thought that Skyclarys activates the nuclear factor erythroid 2-related factor 2 pathway (Nrf2). This helps to reduce cell damage and inflammation.

How is Skyclarys supplied (dosage forms)?

Skyclarys is available as 50 mg oral capsules that are taken by mouth.

How should I store Skyclarys?

Skyclarys should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Skyclarys?

The most common side effects of Skyclarys are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

There may be other side effects of Skyclarys that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Skyclarys?

While less common, the most serious side effects of Skyclarys are described below, along with what to do if they happen.

Severe Allergic Reactions. Skyclarys may cause allergic reactions, which can be serious. Stop taking Skyclarys and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Skyclarys. Your healthcare provider will test your blood before starting and throughout treatment. Keep all appointments to have your blood checked. Call your healthcare provider right away if you experience any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning a yellowish color (also called jaundice)

Heart Failure. Heart failure can happen when taking Skyclarys. Your healthcare provider will test your blood before starting and throughout treatment. Keep all appointments to have your blood checked.

Call your healthcare provider right away if you experience any of the following signs or symptoms of heart failure.

  • Sudden weight gain of three or more pounds in one day or five or more pounds in one week 
  • Swelling in your arms, hands, legs or feet
  • Fast heartbeat
  • Shortness of breath or trouble breathing, especially while lying down
  • Unusual tiredness

Increased Cholesterol Levels. Skyclarys can cause changes in cholesterol levels. Your healthcare provider will test your blood before starting and throughout treatment. Keep all appointments to have your blood checked.

Warnings & Precautions

Who should not use Skyclarys?

Allergies to Ingredients. People who are allergic to any of the following should not take Skyclarys.

  • Omaveloxolone
  • Skyclarys
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Skyclarys.

What should I know about Skyclarys before using it?

Do not take Skyclarys unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Skyclarys with other people, even if they have the same condition as you. It may harm them.

Keep Skyclarys out of the reach of children.

Swallow Skyclarys whole, and do not crush or chew. If you have trouble swallowing the capsules, they can be opened and the contents sprinkled on 2 tablespoons of applesauce. That mixture should be stirred and swallowed right away. Skyclarys should not be mixed with milk or orange juice. 

Do not give Skyclarys by an enteral feeding tube. 

What should I tell my healthcare provider before using Skyclarys?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Skyclarys is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Liver problems
  • Heart problems
  • High cholesterol levels

Hormonal Birth Control. Skyclarys can decrease the effect of hormonal birth control. You should use an alternative method of contraception or use additional non-hormonal contraception during treatment and for 28 days after stopping Skyclarys. 

Other Medicines and Supplements. Skyclarys may interact with other medicines and supplements. Before using Skyclarys, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Skyclarys could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Skyclarys passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Skyclarys while breastfeeding.

How can I get more information about Skyclarys?

For more information about Skyclarys, you can visit the manufacturer’s website at www.skyclarys.com or call them at 800-314-3934.

Interactions

Does Skyclarys interact with foods or drinks?

You should not eat grapefruit or drink grapefruit juice while taking Skyclarys. It can increase the effect of Skyclarys.

Skyclarys should be taken on an empty stomach. Avoid eating within 1 hour of taking Skyclarys, as this can increase the effect of Skyclarys.

There are no known interactions between Skyclarys and alcohol. It is best to limit the amount of alcohol you drink. 

Does Skyclarys interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Skyclarys.

  • Itraconazole (Sporanox), which is a medicine used for fungal infections
  • Verapamil  (Verelan and Calan), which is used for high blood pressure, chest pain, and arrhythmias
  • Rosuvastatin (Crestor), which is used to treat high cholesterol 
  • Midazolam (Versed and Nayzilam), which is a medicine used for seizures, procedural sedation, and other conditions
  • Repaglinide (Prandin), which is a medicine used to control type 2 diabetes
  • Hormonal birth control
  • St. John’s Wort, which is an herbal supplement used for depression, menopausal symptoms, and other conditions 

Many other medicines may alter the blood levels of Skyclarys, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Skyclarys. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Skyclarys?

If you or someone else has used too much Skyclarys, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Skyclarys?

If you miss a dose, then you should skip that dose. Take your next dose at the regular time the next day. Do not take double or extra doses.