SKYCLARYS is a once-daily oral treatment for Friedreich ataxia (FA).
Standard administration:
- Take SKYCLARYS on an empty stomach at least 1 hour before eating
- Swallow SKYCLARYS capsules whole. Do not crush or chew
Sprinkle administration:
If you are not able to swallow whole capsules:
- Take SKYCLARYS capsules on an empty stomach at least 1 hour before eating
- If SKYCLARYS capsules cannot be swallowed whole, the capsules may be opened and the entire contents of both halves sprinkled onto 2 tablespoonfuls (30 mL) of applesauce
- Stir the mixture
- Swallow all the mixture of medicine and applesauce right away. Do not store the mixture of medicine and applesauce to use at a later time
- The contents of the SKYCLARYS capsules should not be mixed with milk or orange juice
- Do not administer SKYCLARYS by an enteral feeding tube
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.
Follow your doctor’s instructions carefully when taking SKYCLARYS.
What should I avoid while taking SKYCLARYS?
Do not drink grapefruit juice or eat grapefruit. These may change the amount of SKYCLARYS in your blood.
What should I do before I start taking SKYCLARYS?
Before taking SKYCLARYS, tell your healthcare provider about all of 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)
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.
- Taking SKYCLARYS with other medicines can cause serious side effects
- SKYCLARYS may affect the way other medicines work, and other medicines may affect how SKYCLARYS works
- Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine
- Do not drink grapefruit juice or eat grapefruit. These may change the amount of SKYCLARYS in your blood
Family planning with SKYCLARYS
Pregnancy: Tell your doctor if you are pregnant or plan to become pregnant. It is not known if SKYCLARYS will harm your unborn baby.
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.
Breastfeeding: Tell your doctor if you 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.
Please see Important Safety Information throughout and accompanying full Prescribing Information, including Patient Information.
Side effects
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, 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 1week)
- 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.
What are the most common 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*
*Defined as affecting 10% or more of patients and more SKYCLARYS patients than untreated patients.
AST/ALT=aspartate aminotransferase/alanine aminotransferase.
These are not all the possible side effects of SKYCLARYS. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Is there anything else I should know?
Tell your doctor if you experience sudden weight gain 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.