Patient leaflet - Skyclarys 50 mg hard capsules

1. What Skyclarys is and what it is used for

What is Skyclarys?

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

What is Skyclarys used for?

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.

How does Skyclarys work?

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.

2. What you need to know before you take Skyclarys

Do not take Skyclarys if you are allergic to omaveloxolone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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.

Talk to your doctor if you get any hypersensitivity reactions (an allergic or allergic-like reaction that may include itchy rash and skin rash). 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.

Talk to your doctor while 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.

Children and adolescents

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.

Other medicines and Skyclarys

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.

Skyclarys with food and drink

Avoid eating grapefruit or grapefruit juice while taking Skyclarys.

Pregnancy

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.

Birth Control

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.

Breast-feeding

Skyclarys passes into breast milk. You and your doctor should discuss the risks and benefits of taking Skyclarys during breast-feeding.

Driving and using machines

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

Skyclarys contains a negligible amount of sodium

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

3. How to take Skyclarys

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is 150 mg (3 capsules) once per day.

Taking Skyclarys

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 you should
If you take more Skyclarys than your doctor prescribed, talk to a doctor immediately. Take this leaflet with you.
If you forget to take Skyclarys
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.
If you stop taking Skyclarys
Do not stop taking this medicine unless your doctor tells you. If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects with Skyclarys could be or could become serious

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.

Other possible side effects of Skyclarys

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

headache
tiredness
sore throat
back pain
muscle spasm
flu
decreased appetite
hypersensitivity (an allergic or allergic-like reaction that may include itchy
rash and skin rash)

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)

Reporting of side effects

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.

5. How to store Skyclarys

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

If the capsule is opened and mixed with apple puree you must eat all the apple puree/medicine mixture immediately after making it. See section 3, Taking Skyclarys.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Skyclarys contains

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)

What Skyclarys looks like and contents of the pack

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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

The Netherlands

Manufacturer(s)

BIOGEN DISTRIBUTION SERVICES LIMITED

United Drug House

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

D24 XKE5

Ireland