SkyClarys

Package leaflet: Information for the patient

Skyclarys 50 mg hard capsules

omaveloxolone
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

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

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 the body.
What is Skyclarys used for?
Skyclarys is used to treat adults and adolescents aged 16 years and older who have Friedreich’s ataxia,
a rare inherited neurodegenerative movement disorder. Friedreich’s ataxia is a rare hereditary disease
that causes progressive damage to the nervous system and movement problems.
How does Skyclarys work?
The protein Nrf2 in the body plays a key role in managing oxidative stress (a condition that can damage cells)
and has a protective function against neurodegenerative diseases. In patients with Friedreich’s ataxia,
Nrf2 activity is reduced. Skyclarys activates Nrf2 so that it can manage oxidative stress.
In a clinical trial, patients treated with Skyclarys showed greater improvement in neurological function tests
compared to patients treated with an inactive substance.

2. What you need to know before taking Skyclarys

Do not take Skyclarys if you are allergic to omaveloxolone or to 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 liver problems, your doctor may decide to adjust the dose or not to start treatment with Skyclarys
• inform your doctor about all the medicines you are taking before starting Skyclarys.

Your doctor will check your liver function and cholesterol levels before starting treatment with
Skyclarys. Your doctor will also check your BNP levels (B-type natriuretic peptide,
a blood test for heart problems) before starting treatment with Skyclarys.
Talk to your doctor while you are taking Skyclarys
Contact your doctor immediately if, during treatment with Skyclarys, you notice a sudden
increase in weight, swelling of the legs, ankles or feet, or shortness of breath, which may
be signs or symptoms of heart problems. Your doctor will decide on the treatment and whether to continue Skyclarys.
Talk to your doctor if you experience hypersensitivity reactions (an allergic or allergy-like reaction, which may include itchy rash and skin eruption).
During treatment with Skyclarys, your doctor will monitor your blood tests. These
will include blood tests to check liver function during treatment with
Skyclarys. Your doctor will decide whether to discontinue Skyclarys if liver problems develop. Other blood tests prescribed by your doctor will monitor cholesterol and BNP levels after starting treatment with Skyclarys.
Inform your doctor if you experience weight loss while taking Skyclarys.
Children and adolescents
Do not administer Skyclarys to children and adolescents under 16 years of age, as it has not been studied in this patient group.
Other medicines and Skyclarys
Inform your doctor if you are taking, have recently taken, or might take any other
medicines, as certain medicines may affect the action of Skyclarys and Skyclarys may also affect the action of certain medicines.
Certain medicines may increase the risk of Skyclarys side effects by increasing Skyclarys levels in the blood. Some of these medicines include:

• itraconazole, fluconazole or ketoconazole (antifungal medicines used to treat various fungal infections)
• cyclosporine (a medicine used after organ transplantation)
• ciprofloxacin or clarithromycin (antibiotics used for bacterial infections)
• fluvoxamine (an antidepressant known as a selective serotonin reuptake inhibitor [SSRI]). If your doctor prescribes one of these medicines, the dose of Skyclarys may be reduced to prevent side effects when both medicines are taken together.

Certain medicines may reduce the effectiveness of Skyclarys by decreasing Skyclarys levels 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 (a medicine used for HIV)

Skyclarys may reduce the effectiveness of certain medicines by decreasing their levels in the blood. Some of these medicines include:

• midazolam (used as a sedative and to treat severe agitation)
• repaglinide (a medicine for controlling type II diabetes)
• rosuvastatin (a statin used to reduce harmful lipids)
• hormonal contraceptives (a type of contraception using hormones to prevent pregnancy, e.g., the pill, patch or vaginal ring).

Inform your doctor if you are taking any medicine, especially those listed above,
as they may affect the action of Skyclarys or other medicines.
Skyclarys with food and drinks
Avoid consuming grapefruit or grapefruit juice during treatment with Skyclarys.
Pregnancy
You must not take Skyclarys if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Inform your doctor immediately if you become pregnant during treatment with Skyclarys.
Contraception
The use of Skyclarys may reduce the effectiveness of hormonal contraception. You must use a different contraceptive method, such as a non-hormonal intrauterine device or barrier methods like condoms. A reliable contraceptive method must be used during treatment with Skyclarys and for 28 days after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
Breast-feeding
Do not breast-feed during treatment with Skyclarys. It is not known whether this medicine passes into breast milk.
Driving and using machines
Some patients may experience fatigue after taking this medicine. If you feel tired after taking Skyclarys, avoid driving or operating machinery.
Skyclarys contains a negligible amount of sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take Skyclarys

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

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

Taking Skyclarys

• Take the capsules on an empty stomach, at least one hour before meals or two hours after.
• Take the capsules at approximately the same time each 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 tablespoons of apple puree. You must consume the entire apple puree/medicine mixture immediately after preparation. Do not store the apple puree/medicine mixture for future use.

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

Some medicines may cause side effects when taken together with Skyclarys. If your doctor prescribes one of these medicines while you are being treated with Skyclarys, your doctor may reduce your Skyclarys dose to prevent side effects when both medicines are taken together.

If you vomit after taking your usual dose, do not take replacement capsules. Take your capsules as usual the next day.

If you take more Skyclarys than you should
If you take more Skyclarys than prescribed, contact your doctor immediately. Bring 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 the missed dose.

If you stop taking Skyclarys
Do not stop taking this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects with Skyclarys may be serious or may become serious
Contact your doctor immediately if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people)

• digestive problems; symptoms may include
  • nausea
  • diarrhoea
  • vomiting
  • stomach pain
  • weight loss
    If you experience any of these side effects, consult your doctor.

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

• increased liver enzymes in the blood (very common, may affect more than 1 in 10 people)
• increased BNP (a marker of heart problems) (common, may affect up to 1 in 10 people)
• changes in cholesterol and triglycerides in the blood (common, may affect up to 1 in 10 people)
  Your doctor will decide on the appropriate treatment and whether to continue Skyclarys.

Other possible side effects of Skyclarys
Very common (may affect more than 1 in 10 people)

• headache
• fatigue
• sore throat
• back pain
• muscle spasm
• influenza
• reduced appetite
• hypersensitivity (an allergic or allergic-like reaction, which may include itchy rash and skin eruption)

Common (may affect up to 1 in 10 people)

• urinary tract infection
• menstrual pain in women (menstrual cramps)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly through the national reporting system listed in Annex V. 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 stated on the container after "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
If the capsule is opened and mixed with apple puree, the entire mixture of apple puree/medicine must be taken immediately after preparation. See section 3, "How to take Skyclarys".
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Skyclarys contains

• The active substance is omaveloxolone.
• Each capsule contains 50 mg of omaveloxolone.
• The other components are: capsule contents: pregelatinized maize starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica; capsule shell: hypromellose, titanium dioxide (E171), brilliant blue FCF (E133), iron oxide yellow (E172); printing ink: shellac (E904), titanium dioxide (E171)

Description of the appearance of Skyclarys and package contents
Skyclarys 50 mg hard capsules consist of an opaque light green body printed with “RTA 408” in white ink and a blue cap printed with “50” in white ink.
Skyclarys 50 mg is available in a pack containing 90 hard capsules and in a pack containing 3 bottles, each bottle holding 90 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Manufacturer(s)
Reata Ireland Limited,
77 Sir John Rogersons Quay Block C, Spaces South Docklands
Dublin 2
D02 VK60
Ireland
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium N.V./S.A. Biogen Lithuania UAB
Tél/Tel: +32 2 219 12 18 Tel: +370 5 259 6176

България Luxembourg/Luxemburg
ТП ЕВОФАРМА Biogen Belgium N.V./S.A.
Teл.: +359 2 962 12 00 Tél/Tel: +32 2 219 12 18

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
Tel: +420 255 706 200 Tel.: +36 1 899 9880

Danmark Malta
Biogen (Denmark) A/S Pharma MT limited
Tlf.: +45 77 41 57 57 Tel: +356 213 37008/9

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
Tel: +49 (0) 89 99 6170 Tel: +31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
Tel: +372 618 9551 Tlf: +47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma SA Biogen Austria GmbH
Τηλ: +30 210 8771500 Tel: +43 1 484 46 13

España Polska
Biogen Spain SL Biogen Poland Sp. z o.o.
Tel: +34 91 310 7110 Tel.: +48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal
Tél: +33 (0)1 41 37 95 95 Tel.: +351 21 318 8450

Hrvatska România
Biogen Pharma d.o.o. Ewopharma România SRL
Tel: +385 (0) 1 775 73 22 Tel: +40 21 260 13 44

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
Tel: +353 (0)1 463 7799 Tel.: +386 1 511 02 90

Ísland Slovenská republika
Icepharma hf Biogen Slovakia s.r.o.
Sími: +354 540 8000 Tel.: +421 2 323 340 08

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
Tel: +39 02 584 9901 Puh/Tel: +358 207 401 200

Κύπρος Sverige
Genesis Pharma Cyprus Ltd Biogen Sweden AB
Τηλ: +357 22765715 Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: +371 68 688 158

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/. Links to other websites on rare diseases and their therapeutic treatments are also provided.