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The following safety information outlines important warnings related to the use of Skyclarys (omaveloxolone). It is crucial to understand these risks and discuss any concerns with your healthcare provider.

• Liver Health: Skyclarys (omaveloxolone) may increase liver enzyme levels, indicating potential liver damage. Regular blood tests before and during treatment are necessary to monitor liver function. Although most individuals do not experience symptoms, be vigilant for signs such as abdominal swelling, pain, yellowing of the skin or eyes, changes in stool color, dark urine, or confusion. Seek immediate medical attention if these occur, as cessation of the medication may be required to prevent further liver damage.

• Heart Function: This medication can elevate brain natriuretic peptide (BNP) levels, which may signal heart failure – a common issue in individuals with FA. It is unclear if raised BNP levels are directly caused by the medication or underlying heart conditions. Notify your healthcare provider if you have a history of heart failure or experience symptoms like shortness of breath, swelling in the extremities, irregular heartbeat, difficulty with exercise, fatigue, or rapid weight gain.

• Cholesterol Levels: Skyclarys (omaveloxolone) has the potential to increase cholesterol levels, typically observed within two weeks of starting treatment, but these levels usually normalize within a month after discontinuation. Your healthcare provider will monitor your cholesterol levels before and during treatment and may prescribe medication to help manage cholesterol if necessary.

In case of an overdose, immediately seek emergency medical assistance. Always follow your healthcare provider's guidance when using Skyclarys (omaveloxolone) and report any unusual symptoms or concerns promptly.

When taking this medication, some individuals may experience common side effects such as nausea, diarrhea, stomach pain, headache, fatigue, and mild increases in liver lab results. Additionally, some people may report bone, muscle, or joint pain, as well as mouth or throat discomfort. These effects are generally mild, but if they persist or worsen, it is advisable to consult your healthcare provider.

Other reported side effects include flu-like symptoms, vomiting, decreased appetite, muscle spasms, back pain, and skin rash. While less common, they should still be discussed with your healthcare provider if they occur.

There are more serious side effects to be aware of, although they are rare. Signs of liver damage, such as persistent nausea, vomiting, yellowing of the skin or eyes, dark urine, or abdominal pain, are serious and require immediate medical attention. Heart-related issues, like an irregular or pounding heartbeat, shortness of breath, sudden weight gain, or swelling in the legs, ankles, or feet, also warrant urgent medical care. Severe allergic reactions are infrequent but can include symptoms such as rash, severe dizziness, or difficulty breathing, and require prompt medical intervention.

Remember, this is not an exhaustive list of potential side effects. If you experience any unexpected reactions, it is important to contact your healthcare provider for further advice.