Lupkynis 7.9 mg soft capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to voclosporin or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines such as ketoconazole tablets (used to treat Cushing’s syndrome when the body produces an excess of cortisol), itraconazole or clarithromycin (used to treat certain fungal and bacterial infections).

Talk to your doctor or pharmacist before taking Lupkynis if any of the following applies to you:

• if your kidney disease gets worse, your dose of this medicine may need to be changed. Your doctor will regularly check how well your kidneys are working.
• if you have risk factors for pure red cell aplasia (PRCA) – a rare disorder in which the bone marrow does not make enough red blood cells. Such risk factors are a former infection with parvovirus B19 or other treatments in the past that may cause PRCA.
• if you suffer from or develop high blood pressure. Your doctor will check your blood pressure every two weeks for the first month and then regularly. He/she may give you a medicine to lower your blood pressure or tell you to stop taking this medicine.
• This medicine can increase the risk of conditions of the nervous system, such as headache, shaking, changes in vision, seizures, confusion or weakness in one or more limbs. If you experience any of these new symptoms or worsening of existing symptoms, your doctor may consider stopping or lowering the dose of this medicine (see section 4).
• if you are planning to have a vaccination or have had a vaccination within the last 30 days. This medicine may affect the response to vaccination, and vaccination during treatment with this medicine may be less effective.
• if you have previously experienced sudden life-threatening allergic reactions (anaphylactic reactions) to soya or peanut, do not take this medicine.

This medicine can increase the potassium levels in your blood, which may be serious and require treatment. Your doctor will check your potassium levels periodically during treatment.

This medicine has not been studied in patients with severe liver problems and is therefore not recommended in these patients.

This medicine may influence the electrical activity of your heart (QT prolongation). This can result in serious heart rhythm disorder. Early symptoms are dizziness and fainting.

This medicine can increase the risk of developing certain types of cancer, particularly of the skin. You should avoid or limit your exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying sunscreen with a high protection factor.

This medicine can increase your risk of developing infections, some of which may be serious or even fatal. Contact your doctor if you have any signs of infection, such as fever, chills or sore throat. Your doctor will decide whether you need to stop taking this medicine (see section 4).

Do not take this medicine if you are under the age of 18 years because it has not been studied in this age group.

This medicine is not recommended if you are over the age of 75 years because it has not been studied in this age group.

Tell your doctor or pharmacist if you are taking or have recently taken or are planning to take any other medicines.

In particular, tell your doctor if you take:

• Medicines used to treat fungal infection such as itraconazole and fluconazole.
• Medicines used to treat Cushing’s syndrome (when the body produces an excess of cortisol), such as ketoconazole tablets.
• Medicines used to treat high blood pressure or heart problems such as digoxin, diltiazem and verapamil.
• Medicines to prevent the formation of blood clots such as dabigatran etexilate.
• Medicines used to treat epilepsy such as carbamazepine and phenobarbital.
• Herbal preparations containing St. John’s Wort, used to treat mild depression.
• Medicines for the relief of symptoms associated with seasonal allergic rhinitis such as fexofenadine.
• Antibiotic medicines used to treat bacterial infections such as rifampicin, clarithromycin and erythromycin.
• Medicines that lower cholesterol such as simvastatin, atorvastatin, rosuvastatin and pravastatin.
• Medicines used to treat HIV infections, such as the antiretroviral efavirenz.

This medicine can be taken with or without food. Avoid eating grapefruit and drinking grapefruit juice during treatment with this medicine, since these can affect how the medicine works.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine is not recommended during pregnancy and in women of childbearing potential not using contraception.

Tell your doctor if you are breast-feeding. This medicine can pass into breast milk and it is not known if this medicine can affect your baby. Your doctor will discuss with you whether to stop treatment with this medicine while you are breast-feeding, or to stop breast-feeding.

There are no data on the effect of this medicine on human fertility.

Lupkynis is not expected to have any effect on your ability to drive and use machines.

This medicine contains 21.6 mg of alcohol (ethanol) in each capsule.

Therefore, a dose of 3 capsules of Lupkynis contains 64.8 mg ethanol, which is equivalent to less than 2 mL beer or 1 mL wine. This small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 28.7 mg of sorbitol in each capsule.

This medicine may contain trace amounts of soya lecithin. If you experience anaphylactic reactions to soya or peanut, you must not use this medicine.

If you have accidentally taken too many capsules, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose may include a fast heartbeat and tremors (uncontrolled shaking or trembling in one or more parts of the body).

If a dose is missed, take it as soon as possible and within 4 hours of missing the dose. If more than 4 hours have passed since the time you normally take the medicine, just skip that dose and take the next regular dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Do not stop your treatment unless your doctor tells you to do so.

If any of these occur, seek immediate medical advice as your doctor may advise you to stop taking this medicine or reduce the dose.

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

• Symptoms of infection (such as fever, body aches, feeling tired, coughing or sneezing, nausea, vomiting or diarrhoea)

Common (may affect up to 1 in 10 people)

• Newly developing symptoms of nerve or brain problems, such as seizures

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

• Upper chest infection
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)
• Headache
• Increased blood pressure
• Cough
• Diarrhoea
• Pain in the abdomen (belly)
• Changes in your kidney function which could reduce the amount of urine you produce and may cause new or worsening swelling in your legs or feet

Common (may affect up to 1 in 10 people)

• Infections, that can either be bacterial such as urinary tract infections or viral such as shingles
• Inflammation of the stomach and intestines
• Flu
• Increased levels of potassium seen in blood test
• Decreased appetite
• Tremors
• Feeling sick
• Abnormal swelling, bleeding and/or inflammation of the gums
• Indigestion
• Hair loss
• Excessive and/or abnormal hair growth on any part of the body

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 voclosporin. Each soft capsule of Lupkynis contains 7.9 mg of voclosporin.
• The other ingredients are:
  Capsule content: ethanol, vitamin E (E307) polyethylene glycol succinate (tocofersolan), polysorbate 40 and medium-chain triglycerides
  Capsule shell: gelatin, sorbitol, glycerin, purified water, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
  Processing aid: soya lecithin

Lupkynis 7.9 mg pink/orange, soft capsules measuring approximately 13 mm × 6 mm packed in blisters. Each blister contains 18 soft capsules. One carton contains 180 or 576 soft capsules.

Not all pack sizes may be marketed.

For any information about this medicine, please contact: