Skyclarys 50 mg hard capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Skyclarys is and what it is used for
2. What you need to know before you take Skyclarys
3. How to take Skyclarys
4. Possible side effects
5. How to store Skyclarys
6. Contents of the pack and other information

Skyclarys contains the active substance omaveloxolone, which activates a specific protein, Nrf2, in your body.

Skyclarys is used to treat adults and adolescents who are at least 16 years of age who have Friedreich’s ataxia, a neurodegenerative movement disorder. Friedreich’s ataxia is a rare inherited disease that causes progressive damage to your nervous system and movement problems.

The protein called Nrf2 in your body has a key role in managing oxidative stress (a condition that can damage cells in your body) and has a protective role against neurodegenerative diseases. In patients with Friedreich’s ataxia, Nrf2 activity is reduced. Skyclarys activates Nrf2 so it can manage oxidative stress.

In a clinical trial patients treated with Skyclarys scored better on tests of neurological function than patients who were treated with an inactive substance.

Talk to your doctor before taking Skyclarys:

• If you have problems with your liver, your doctor may decide to change the dose or not start treatment with Skyclarys.
• Tell your doctor about all the medicines you are taking before you start Skyclarys.

Your doctor will check to see how well your liver is working and will check your cholesterol level before you start taking Skyclarys. Your doctor will also check your level of BNP (B-type natriuretic peptide, a blood test for heart problems) before you start taking Skyclarys.

Contact your doctor immediately if you have sudden weight gain, swelling of legs, ankles, or feet, or shortness of breath, which may be signs or symptoms of heart problems while taking Skyclarys. Your doctor will decide on treatment and whether Skyclarys should be continued.

Your doctor will be checking blood tests while you are taking Skyclarys. This will include liver blood tests to see how your liver is working while taking Skyclarys. Your doctor will decide on whether to discontinue Skyclarys if liver problems develop. Other blood tests that your doctor will do will check cholesterol and BNP after you start Skyclarys.

Tell your doctor if you have weight loss with Skyclarys.

Do not give Skyclarys to children and adolescents below the age of 16 years because it has not yet been studied in this group of patients.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. This is because some medicines may affect the way Skyclarys works. Also, Skyclarys may affect the way some medicines work.

Certain medicines may increase the risk of side effects of Skyclarys by increasing the levels of Skyclarys in the blood. Some of these medicines include:

• itraconazole, fluconazole, or ketoconazole (antifungal medicines used to treat a number of fungal infections)
• cyclosporine (a medicine used after organ transplant)
• ciprofloxacin or clarithromycin (antibiotics used for bacterial infections)
• fluvoxamine (an antidepressant known as a selective serotinin reuptake inibitor [SSRI])

If your doctor prescribes one of these medicines, your dose of Skyclarys may be reduced to prevent side effects when taking both drugs at the same time.

Certain medicines may reduce how well Skyclarys works by decreasing the amount of Skyclarys in the blood. Some of these medicines include:

• St. John’s wort (a herbal remedy used for mild depression)
• rifampicin (used to treat tuberculosis)
• carbamazepine, phenobarbital, phenytoin, primidone (used to treat epilepsy)
• efavirenz (medicine used for HIV)

Skyclarys may reduce how well some other medicines work by decreasing the amount of these medicines in the blood. Some of these medicines include:

• midazolam (used as a sedative and to treat severe agitation)
• repaglinide (a medicine to control type II diabetes)
• rosuvastatin (a statin medicine used to reduce harmful lipids)
• hormonal contraceptives (a type of birth control that uses homones to prevent pregnancy, such as the pill, patch, or ring)

Talk to your doctor if you are taking any medicines, particularly those mentioned above, as they may affect the way Skyclarys or other medicines work.

Avoid eating grapefruit or grapefruit juice while taking Skyclarys.

You should not take Skyclarys if you are pregnant, think you may be pregnant, or are planning to have a baby. Tell your doctor immediately if you become pregnant while you are being treated with Skyclarys.

Using Skyclarys can reduce the effectiveness of hormonal birth control. You should use a different method of birth control, such as a non-hormonal IUD (intrauterine device) or barrier contraceptives such as condoms. A reliable method of birth control should be used during Skyclarys treatment and for 28 days after stopping treatment with Skyclarys. Talk to your doctor about the most suitable birth control for you.

Do not breast-feed your baby while you are being treated with Skyclarys. It is not known if this medicine passes into the breast milk.

Some patients may feel tired after taking this medicine. If you feel tired after taking Skyclarys, avoid driving and using machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

• Take the capsules on an empty stomach at least one hour before or two hours after eating.
• Take the capsules at about the same time during the day.
• Swallow the capsules whole with a glass of water.
• If you are unable to swallow the capsules whole, open them and sprinkle the entire contents onto 2 tablespoonfuls of apple puree. You must eat all the apple puree/medicine mixture immediately after making it. Do not store the apple puree/medicine mixture for future use.

If you have problems with your liver, your doctor may decide to change the dose or not start treatment with Skyclarys.

Some medicines may cause side effects when taken at the same time as Skyclarys. If your doctor prescribes one of these medicines while you are taking Skyclarys, your doctor may reduce the dose of Skyclarys to prevent side effects when taking both drugs at the same time.

If you are sick after taking your usual dose, do not take replacement capsules. Take the capsules as usual the following day.

If you take more Skyclarys than your doctor prescribed, talk to a doctor immediately. Take this leaflet with you.

If you miss a dose of Skyclarys, take the next dose as usual the following day. Do not take a double dose to make up for a forgotten dose.

Do not stop taking this medicine unless your doctor tells you.

Talk to your doctor immediately if you have any of these side effects:

Very common (may affect more than 1 in 10 people)

• digestive problems. You may have symptoms such as
  • nausea (feeling sick)
  • diarrhoea
  • vomiting
  • stomach pain
  • decrease in weight

If you have any of these side effects, talk to your doctor.

Based on your blood tests, your doctor may tell you that you have:

• high liver enzymes in your blood (very common, may affect more than 1 in 10 people)
• increased BNP (a marker for heart problems); (common, may affect up to 1 in 10 people)
• changes in your blood cholesterol and triglycerides (common, may affect up to 1 in 10 people)

Your doctor will decide on treatment and whether Skyclarys should be continued.

Very common (may affect more than 1 in 10 people)

• headache
• tiredness
• sore throat
• back pain
• muscle spasm
• flu
• decreased appetite

Common (may affect up to 1 in 10 people)

• urinary tract infection (infection of the structures that carry urine, UTI)
• period pains in women (menstrual cramps)

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is omaveloxolone.
• Each capsule contains 50 mg omaveloxolone.
• The other ingredients are:
  Capsule fill: pregelatinized maize starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silica, colloidal anhydrous
  Capsule shell: hypromellose, titanium dioxide (E171), Brilliant Blue FCF (E133), ferric oxide yellow (E172)
  Printing ink: shellac (E904), titanium dioxide (E171)

Skyclarys 50 mg hard capsules are made of an opaque light green body imprinted with “RTA 408” in white ink and a blue cap imprinted with “50” in white ink.

Skyclarys 50 mg is available in a pack containing 90 hard capsules and in a pack of 3 bottles, each containing 90 hard capsules.