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Skyclarys

omaveloxolone
Used for Friedreich's Ataxia
Used for Friedreich's Ataxia

Skyclarys (omaveloxolone) is the first approved medication used to treat a rare, genetic problem called Friedreich's ataxia (FA) in people 16 years of age and older. It comes as capsules that are taken by mouth once per day. The most common side effects of Skyclarys (omaveloxolone) include headache, nausea, stomach pain, and higher liver lab results.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Cydnee Ng, PharmD
Last reviewed on April 6, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageReferencesPricesMedicare
basics-icon

What is Skyclarys (omaveloxolone)?

What is Skyclarys (omaveloxolone) used for?

  • Friedreich's ataxia (FA)

How Skyclarys (omaveloxolone) works

Skyclarys (omaveloxolone) is a nuclear factor erythroid 2-related factor 2 (Nrf2) activator. Nrf2 is a signaling pathway in the body that's involved in lowering inflammation to prevent tissue and cell damage. It's not exactly known how Skyclarys (omaveloxolone) works to treat Friedreich's ataxia. But it's thought to work by turning on the Nrf2 signaling pathway. This might prevent further damage to the nervous system that's affected by Friedreich's ataxia.

Are you looking for information on oxandrolone or naloxone (Narcan) instead?

Drug Facts

Common BrandsSkyclarys
Drug ClassNuclear factor erythroid 2-related factor 2 (Nrf2) activator
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Skyclarys (omaveloxolone)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Higher liver lab results (37%)
  • Headache (37%)
  • Nausea (33%)
  • Stomach pain (29%)
  • Fatigue (24%)
  • Diarrhea (20%)
  • Bone, muscle, or joint pain (20%)
  • Mouth or throat pain (18%)

Other Side Effects

  • Flu-like symptoms
  • Vomiting
  • Lower appetite
  • Muscle spasms
  • Back pain
  • Rash

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Liver damage: swelling of your stomach, yellowing of your skin or the whites of your eyes, clay-colored stool, stomach pain, nausea, vomiting, confusion
  • Heart failure: shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; not able to exercise; tiredness; weakness

Source: FDA

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Skyclarys (omaveloxolone)

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Pros

Works well to improve brain and nerve function in people with FA

Taken by mouth once per day

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Cons

Can't use for people younger than 16 years of age

Not shown to help with exercise ability

Might raise your cholesterol levels

pharmacist-tips

Pharmacist tips for Skyclarys (omaveloxolone)

pharmacist

  • Take Skyclarys (omaveloxolone) once per day at the same time every day. Take the medication on an empty stomach at least 1 hour before food. This is because food can raise the levels of Skyclarys (omaveloxolone) in your body, which can raise your risk for side effects.

    • Swallow the Skyclarys (omaveloxolone) capsules whole. Don't open, crush, or chew the capsules. If you're having trouble swallowing the capsules, contact your provider.

      • Mark your calendar to get your blood tests done on time. This will help you keep up with blood tests that you need to get while taking Skyclarys (omaveloxolone). These blood tests help your provider check your heart and liver function and cholesterol levels to make sure the medication is safe for you.

        • Follow a healthy and balanced diet that's low in fat while you're taking Skyclarys (omaveloxolone). Also make sure to get regular exercise during treatment. Skyclarys (omaveloxolone) can raise your cholesterol so it's important to keep your heart healthy.

          • Tell your provider or pharmacist about all the medications you take or plan to take during treatment with Skyclarys (omaveloxolone). They can make sure that your medications are safe to take together. Some medications can change the levels of Skyclarys (omaveloxolone) in your body. This change can affect your risk of side effects or affect how well your medications work for you. Examples include amiodarone (Pacerone), amlodipine (Norvasc), carbamazepine (Tegretol), and ritonavir (Norvir). You might need dose adjustments to your medications or a change in your treatment plan.

            • Avoid grapefruit or grapefruit juice while taking Skyclarys (omaveloxolone). Grapefruit can raise the amount of the medication in your body, which raises your risk of side effects.

              • It's recommended to use non-hormonal birth control during treatment with Skyclarys (omaveloxolone) and for at least 28 days after your last dose. Avoid hormonal birth control methods (e.g., pill, vaginal ring, implant). This is because Skyclarys (omaveloxolone) might make hormonal birth control not work as well, which can raise the risk for an unwanted pregnancy.

                • If you're pregnant, thinking of becoming pregnant, or breastfeeding while taking Skyclarys (omaveloxolone), contact your provider about the risks and benefits of using the medication. We don't know for sure whether Skyclarys (omaveloxolone) is safe to take while pregnant or breastfeeding because it hasn't been studied yet.

                  • If you accidentally forget to take a Skyclarys (omaveloxolone) dose, skip the missed dose. Take your next dose at the regularly scheduled time. Don't double up the dose to make up for the missed dose because doing so can raise your risk of side effects.

                    faqs

                    Frequently asked questions about Skyclarys (omaveloxolone)

                    What is Friedreich's ataxia (FA)?
                    Friedreich's ataxia (FA) is a rare, genetic problem that mainly affects your nerves and heart. This genetic problem happens when there's not enough of a protein called frataxin in the body. Frataxin is important for certain nerve and muscle cells to work properly. So without enough frataxin, there are problems with your nervous system and sometimes heart. The first and most common symptom of FA is loss of balance and coordination. Other symptoms include weakness, difficulty with speech, difficulty swallowing, and muscle and bone problems. FA can also cause heart failure and diabetes. Studies show that treatment with Skyclarys (omaveloxolone) can help improve nerve function in people with FA.
                    How well does Skyclarys (omaveloxolone) work?
                    A two-part study looked at how well Skyclarys (omaveloxolone) worked to improve FA symptoms in people between the ages of 16 and 40 with the condition. The first part of the study showed that after about 3 months, Skyclarys (omaveloxolone) helped improve brain and nerve function, but not exercise ability. The second part of the study looked further into the effect of Skyclarys (omaveloxolone) on nerve function. Results showed that after almost a year of treatment, people taking Skyclarys (omaveloxolone) had significantly better nerve function than those who took placebo. Some properties of nerve function that the study looked at were arm and leg coordination, stability when standing, and speech, chewing, and swallowing abilities. If you're taking Skyclarys (omaveloxolone), follow up with your provider regularly to discuss how well treatment is working for you.
                    How long does it take for Skyclarys (omaveloxolone) to work?
                    In studies, Skyclarys (omaveloxolone) generally started to help improve nerve function within 3 months. Some specific properties of nerve function included in the studies were arm and leg coordination, stability when standing, and speech, chewing, and swallowing abilities. Improvements in nerve function might last for as long as 3 years with continued treatment. But everyone responds differently to Skyclarys (omaveloxolone), and your experience with treatment might be different from others. For this reason, follow up with your provider regularly to make sure Skyclarys (omaveloxolone) is helping your FA.
                    Are there any blood tests I need to get before I can start Skyclarys (omaveloxolone)?
                    Yes, there are a few blood tests you'll need to get before you can start taking Skyclarys (omaveloxolone). These blood tests help check the health of your liver, heart, and cholesterol levels. Because Skyclarys (omaveloxolone) can cause side effects that affect these parts of your body, your provider will order these blood tests before you start the medication to make sure it's safe for you. Throughout treatment, they'll also regularly order these blood tests for you to get. Ask your provider if you have any questions about these blood tests, what they're used to check for, and your lab results.
                    How long do I have to take Skyclarys (omaveloxolone)?
                    Since FA is a genetic problem, there isn't a specific amount of time you'll need to take Skyclarys (omaveloxolone) for. Your provider will regularly follow up with you to see how you're doing with Skyclarys (omaveloxolone) treatment. You'll likely continue taking the medication as long as it's helping your FA symptoms and you're able to tolerate the side effects (e.g., headache, nausea, stomach pain).
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                    What are the risks and warnings for Skyclarys (omaveloxolone)?

                    Skyclarys (omaveloxolone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                    risk-warning

                    Liver problems

                    Skyclarys (omaveloxolone) can raise your liver enzyme levels in the blood, which can be a sign of liver injury. You'll need to get blood tests done before you start Skyclarys (omaveloxolone) and during treatment so your provider can check your liver health. Although most people didn't have symptoms if they had higher liver enzyme levels during studies, watch out for any symptoms of serious liver problems while you're taking Skyclarys (omaveloxolone). Get medical help right away if you notice swelling of your stomach, stomach pain, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), dark or brown urine, or confusion. You might need to stop taking Skyclarys (omaveloxolone) to prevent further liver damage.

                    risk-warning

                    Heart failure

                    • Risk factors: History of heart failure

                      Skyclarys (omaveloxolone) might raise the brain natriuretic peptide (BNP) levels in your blood. BNP is a marker of heart function, and a rise in BNP levels can be a sign of heart failure. Keep in mind that heart failure is a common complication of FA. So, it's not clear whether these changes in BNP levels are due to Skyclarys (omaveloxolone) or heart complications of FA. Let your provider know if you currently have heart failure or have any symptoms of heart failure while taking Skyclarys (omaveloxolone). Look out for any shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; trouble exercising; tiredness; or sudden weight gain.

                      risk-warning

                      High cholesterol levels

                      Skyclarys (omaveloxolone) can raise your cholesterol levels. In studies, people had higher cholesterol levels within the first 2 weeks of starting Skyclarys (omaveloxolone). Then, their cholesterol levels went back to normal within 1 month after stopping the medication. Your provider will check your cholesterol levels before you start Skyclarys (omaveloxolone) and periodically during treatment. They might prescribe you medications to help manage your cholesterol levels if you need it.

                      dosage

                      Skyclarys (omaveloxolone) dosage forms

                      Typical dosing for Skyclarys (omaveloxolone)

                      The typical dose is 150 mg (3 capsules) by mouth once per day. The capsules are taken on an empty stomach at least 1 hour before eating food.

                      Your dose might differ if you have liver problems or if you're taking certain medications that interact with Skyclarys (omaveloxolone).

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                      References

                      Best studies we found

                      Ahmed, S. M. U., et al. (2017). Nrf2 signaling pathway: Pivotal roles in inflammation. Biochimica et Biophysica Acta (BBA) - Molecular Basis of Disease.

                      American Heart Association. (2023). Managing heart failure symptoms.

                      Carreras, E., et al. (2019). Table 31.1: CYP3A4 substrates, inhibitors and inducers commonly used in HSCT (non-limitative list) (Flockhart 2018; Medicines Complete 2018). The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies.

                      View All References (8)

                      Lynch, D. R., et al. (2018). Safety, pharmacodynamics, and potential benefit of omaveloxolone in Friedreich ataxia. Annals of Clinical and Translational Neurology.

                      Lynch, D. R., et al. (2021). Safety and efficacy of omaveloxolone in Friedreich ataxia (MOXIe Study). Annals of Neurology.

                      Lynch, D. R., et al. (2023). Efficacy of omaveloxolone in Friedreich's ataxia: Delayed-start analysis of the MOXIe extension. Movement Disorders.

                      MedlinePlus. (2021). Friedreich ataxia.

                      National Institute of Neurological Disorders and Stroke. (2023). Friedreich ataxia.

                      National Organization for Rare Disorders. (2023). Friedreich’s ataxia.

                      Reata Pharmaceuticals, Inc. (2023). Skyclarys™ (omaveloxolone) capsules, for oral use [package insert].

                      U.S. Food and Drug Administration. (2023). FDA approves first treatment for Friedreich’s ataxia.

                      GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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