Lupkynis 7.9 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lupkynis 7.9 mg soft capsules

voclosporin (voclosporin)

This medicine is subject to additional monitoring, which will allow for rapid identification of new information on its safety. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lupkynis is and what it is used for

Lupkynis contains the active substance voclosporin. It is used for the treatment of lupus nephritis (inflammation of the kidney caused by lupus) in adults aged 18 years and older.

The active substance in Lupkynis belongs to a group of medicines known as calcineurin inhibitors, which can be used to control the body's immune response (immunosuppressants). In lupus, the immune system (the body's natural defenses) mistakenly attacks parts of the body, including the kidneys (lupus nephritis). By reducing the immune system's response, the medicine reduces kidney inflammation and alleviates symptoms such as swelling of the legs, ankles or feet, high blood pressure, and fatigue, while also improving kidney function.

2. What you need to know before taking Lupkynis

Do not take Lupkynis:

• If you are allergic to voclosporin or to 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 excess cortisol), itraconazole, or clarithromycin (used to treat certain fungal and bacterial infections).

Warnings and precautions

Talk to your doctor or pharmacist before starting Lupkynis if any of the following apply to you:

• If your kidney disease worsens, it may be necessary to adjust the dose of this medicine. Your doctor will regularly monitor 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 produce enough red blood cells. These risk factors include a previous parvovirus B19 infection or prior treatment with therapies that may cause PRCA.
• If you have or develop high blood pressure. Your doctor will measure your blood pressure every two weeks during the first month and then regularly thereafter. You may be given medication to lower your blood pressure or advised to stop taking this medicine.
• This medicine may increase the risk of nervous system disorders such as headache, tremors, changes in vision, seizures, confusion, or weakness in one or more limbs. If you experience any new symptoms or worsening of existing ones, your doctor may consider stopping or reducing the dose of this medicine (see section 4).
• If you plan to be vaccinated or have been vaccinated within the last 30 days. This medicine may affect your response to vaccination, and vaccination during treatment with this medicine may be less effective.
• If you have previously experienced sudden, potentially life-threatening allergic reactions (anaphylactic reactions) to soy or peanuts, do not take this medicine.

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

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

This medicine may affect the electrical activity of your heart (QT interval prolongation). This may lead to serious heart rhythm disorders. Early symptoms include dizziness and fainting.

Sunlight and ultraviolet light

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

Infections

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

Children and adolescents

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

Elderly patients

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

Other medicines and Lupkynis

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

In particular, inform your doctor if you are taking:

• Medicines used to treat fungal infections, such as itraconazole and fluconazole.
• Medicines used to treat Cushing's syndrome (when the body produces excess cortisol), such as ketoconazole tablets.
• Medicines used to treat high blood pressure or heart problems, such as digoxin, diltiazem, and verapamil.
• Medicines to prevent 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 relief of symptoms associated with seasonal allergic rhinitis, such as fexofenadine.
• Antibiotic medicines used to treat bacterial infections, such as rifampicin, clarithromycin, and erythromycin.
• Cholesterol-lowering medicines, such as simvastatin, atorvastatin, rosuvastatin, and pravastatin.
• Medicines used to treat HIV infection, such as the antiretroviral efavirenz.

Taking Lupkynis with food and drink

This medicine can be taken with or without food. Avoid eating grapefruit or drinking grapefruit juice during treatment with this medicine, as they may affect its effectiveness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

This medicine is not recommended during pregnancy, or in women of childbearing age who are not using contraceptive methods.

Inform your doctor if you are breastfeeding. This medicine may pass into breast milk, and it is unknown whether it could affect your baby. Your doctor will advise you whether to stop treatment with this medicine while breastfeeding or to stop breastfeeding.

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

Driving and using machines

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

Lupkynis contains alcohol

This medicine contains 21.6 mg of alcohol (ethanol) in each capsule. Therefore, a dose of 3 Lupkynis capsules contains 64.8 mg of ethanol, equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

Lupkynis contains sorbitol

This medicine contains 28.7 mg of sorbitol in each capsule.

Lupkynis may contain soya lecithin

This medicine may contain traces of soya lecithin. If you have experienced anaphylactic reactions to soy or peanuts, you should not use this medicine.

3. How to take Lupkynis

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Lupkynis is three capsules twice daily, taken orally.

The capsules should be swallowed whole and may be taken with or without food.

Take the daily doses at approximately the same time each day, with an interval of at least 8 hours between doses, and ideally with an interval as close as possible to 12 hours (for example, at 8:00 a.m. and 8:00 p.m.).

This medicine should be used in combination with another immunosuppressant medicine called mycophenolate mofetil.

If you take more Lupkynis than you should

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

If you forget to take Lupkynis

If you forget to take a dose, take it as soon as possible within 4 hours of missing the dose. If more than 4 hours have passed since the time you usually take the medicine, simply skip that dose and take the next dose at your usual time. Do not take a double dose to make up for missed doses.

If you stop taking Lupkynis

Do not stop treatment unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:

Serious adverse effects

If any of these occur, see your doctor immediately, as they may advise you to stop taking this medicine or to reduce the dose.

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

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

Common (may affect up to 1 in 10 people)

• New symptoms of nerve or brain problems, such as seizures

Other adverse effects

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

• Infection of the upper chest
• Reduction in the number of red blood cells, which may make the skin look pale and cause weakness or shortness of breath (anaemia)
• Headache
• Increased blood pressure
• Cough
• Diarrhoea
• Abdominal (stomach) pain
• Changes in kidney function that could reduce the amount of urine produced and may cause new or worsening swelling in the legs or feet

Common (may affect up to 1 in 10 people)

• Fever, cough, difficulty or pain when breathing, wheezing, chest pain when breathing (possible symptoms of pneumonia)
• Infections, which may be bacterial, such as urinary tract infections, or viral, such as herpes
• Inflammation of the stomach and intestines
• Influenza (flu)
• Increased levels of potassium observed in blood tests
• Loss of appetite
• Tremors
• Nausea
• Abnormal swelling, bleeding and/or inflammation of the gums
• Mouth ulcers
• Indigestion
• Hair loss
• Excessive and/or abnormal hair growth anywhere on the body
• Tiredness

Frequency not known (cannot be estimated from available data)

• Hypersensitivity

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lupkynis

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 "CAD" and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original blister pack to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lupkynis

• The active substance is voclosporin. Each soft capsule of Lupkynis contains 7.9 mg of voclosporin.
• The other components are:

Capsule contents: ethanol, vitamin E polyethylene glycol succinate (E307) (tocofersolan), polysorbate 40, and medium-chain triglycerides.

Capsule shell: gelatin, sorbitol, glycerin, purified water, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

Processing aid: soybean lecithin.

Appearance of the product and pack contents

Lupkynis 7.9 mg is available as soft capsules, pink/orange in color, approximately 13 mm × 6 mm, packed in blisters. Each blister contains 18 soft capsules. Each carton contains either 180 or 576 soft capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT Amsterdam

The Netherlands

Manufacturer responsible for manufacturing

Millmount Healthcare Limited

Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60,

Ireland

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

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.