Skyclarys
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.
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.
Drug facts
| Common Brands | Skyclarys |
|---|---|
| Drug Class | Nuclear factor erythroid 2-related factor 2 (Nrf2) activator |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
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%)
Less Common Side Effects
- Flu-like symptoms
- Vomiting
- Lower appetite
- Muscle spasms
- Back pain
- Rash
Skyclarys (omaveloxolone) 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
The following Skyclarys (omaveloxolone) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Muscle pain
- Nausea
- Stomach pain
Pros and cons of Skyclarys (omaveloxolone)
Pros
- Works well to improve brain and nerve function in people with FA
- Taken by mouth once per day
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 for Skyclarys (omaveloxolone)
- 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.
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.
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.
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.
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.
Skyclarys (omaveloxolone) dosage
Typical dosage 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).
Skyclarys (omaveloxolone) images
