SKYCLARYS is a once-daily oral treatment for Friedreich ataxia (FA).
- Take SKYCLARYS exactly as your healthcare provider tells you to take it
- SKYCLARYS should be taken on an empty stomach at least 1 hour before you eat
- Swallow SKYCLARYS capsules whole. Do not open, crush, or chew
- If you miss a dose, then you should skip the missed dose and take the next dose at the regular time the next day. Do not double your next dose or take more than the prescribed dose
Can some things interfere with treatment?
It is important to avoid certain things when taking SKYCLARYS as they may change the amount of SKYCLARYS in your blood.
SKYCLARYS may reduce the efficacy of hormonal birth control. Women who use hormonal birth control should use another form of birth control such as a non-hormonal intrauterine system or an extra non-hormonal birth control such as condoms while using SKYCLARYS and for 28 days after stopping SKYCLARYS.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.
What are the possible side effects of SKYCLARYS?
In the clinical trial, the most common side effects of SKYCLARYS were elevated liver enzymes, along with headache, nausea, stomach pain, and tiredness. Some people also experienced diarrhea, muscle aches, and pain in the mouth, throat, or neck. These are not all the possible side effects of SKYCLARYS. Call your doctor for medical advice about side effects.
Most common side effects*
Side effectsSKYCLARYS patientsUntreated patients
Elevated liver enzymes (AST/ALT)37%2%
Muscle aches and pain20%15%
Mouth, throat, or neck pain18%6%
Defined as affecting 10% or more of patients and more SKYCLARYS patients than untreated patients.
AST/ALT=aspartate aminotransferase/alanine aminotransferase.
Is there anything else I should know?
Tell your doctor if you experience any sudden changes in weight while taking SKYCLARYS, as this may be a sign of a serious heart condition.
Your doctor will continue to monitor your liver enzymes, as well as your cholesterol and levels of a certain protein in your blood, while you are taking SKYCLARYS.
Please read the Important Safety Information below and the SKYCLARYS Patient Information.
What is SKYCLARYS?
SKYCLARYS is used for the treatment of Friedreich ataxia in adults and children 16 years of age and older.
Before taking SKYCLARYS, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems.
- have a history of heart problems, including heart failure.
- have a high level of fat in your blood (high blood cholesterol).
- are pregnant or plan to become pregnant.
- It is not known if SKYCLARYS will harm your unborn baby.
- Women who use hormonal birth control should use another form of birth control such as a non-hormonal intrauterine system or an extra non-hormonal birth control such as condoms while using SKYCLARYS and for 28 days after stopping SKYCLARYS.
- are breastfeeding or plan to breastfeed. It is not known if SKYCLARYS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SKYCLARYS.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medications interact with SKYCLARYS. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of SKYCLARYS?
SKYCLARYS may cause serious side effects, including:
- increase in blood liver enzymes. Some people taking SKYCLARYS have had an increase in
the level of liver enzymes in their blood. Your healthcare provider will do liver function tests
- before you start taking SKYCLARYS
- every month for the first 3 months after starting your treatment with SKYCLARYS
- during certain times as needed while taking SKYCLARYS
If your liver enzymes increase, your healthcare provider may change your dose during treatment, stop treatment for some time, or completely stop treatment with SKYCLARYS.
- increase in a blood protein called B-Type Natriuretic Peptide (BNP). BNP tells how
well your heart is
working. Your healthcare provider will check your BNP levels before your treatment with SKYCLARYS. Tell
your healthcare provider if you have signs and symptoms of your heart not working well such as too much
fluid in your body (fluid overload). Signs and symptoms may include:
- sudden weight gain (3 pounds or more of weight gain in 1 day, or 5 pounds or more of weight gain in 1 week)
- swelling in your arms, hands, legs, or feet (peripheral edema)
- fast heartbeat (palpitations)
- shortness of breath
If you have symptoms of fluid overload that is considered a side effect of SKYCLARYS, your healthcare provider may stop treatment with SKYCLARYS.
- changes in cholesterol levels. Increases in low density lipoprotein cholesterol (LDL-C) or bad cholesterol and decreases in high density lipoprotein cholesterol (HDL-C) or good cholesterol have happened during treatment with SKYCLARYS.
Your healthcare provider will check your cholesterol levels before and during your treatment with SKYCLARYS.
The most common side effects of SKYCLARYS include:
- increased liver enzymes (ALT/AST)
- stomach pain
- muscle pain
These are not all the possible side effects of SKYCLARYS. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA.