LUPKYNIS 7.9 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lupkynis 7.9 mg Soft Capsules

Voclosporin

This medicinal product is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

• 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.

Contents of the pack

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

1. What is Lupkynis and what is it used for

Lupkynis contains the active substance voclosporin. It is used to treat lupus nephritis (inflammation of the kidney caused by lupus) in adults from 18 years of age.

The active substance of 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 its own body, including the kidneys (lupus nephritis). By reducing the immune system's response, the medicine reduces kidney inflammation and decreases symptoms such as swelling of the legs, ankles, or feet, high blood pressure, and fatigue, as well as improving kidney function.

2. What you need to know before you take Lupkynis

Do not take Lupkynis:

• 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 too much cortisol), itraconazole, or clarithromycin (used to treat certain fungal and bacterial infections).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Lupkynis if you have any of the following:

• If your kidney disease worsens, it may be necessary to change the dose of this medicine. Your doctor will regularly check your kidney function.
• 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 are a previous parvovirus B19 infection or previous treatment with medications that can cause PRCA.
• If you have high blood pressure. Your doctor will check your blood pressure every two weeks for the first month and then regularly. You may be given a medicine to lower your blood pressure or be told 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 of these new symptoms or worsening of existing ones, your doctor may consider stopping or reducing the dose of this medicine (see section 4).
• If you are scheduled to be vaccinated or have been vaccinated in 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 life-threatening allergic reactions (anaphylactic reactions) to soy or peanuts, do not take this medicine.

This medicine may increase potassium levels in the blood, 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 kidney impairment and is therefore not recommended in these patients.

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

Sunlight and ultraviolet light

This medicine may increase the risk of developing certain types of cancer, especially skin cancer. You should avoid or limit your exposure to sunlight and ultraviolet rays by using protective clothing and applying sunscreen with a high protection factor frequently.

Infections

This medicine may increase the risk of developing infections, some of which can be serious or even life-threatening. Contact your doctor if you have 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 old because it has not been studied in this age group.

Elderly patients

This medicine is not recommended if you are over 75 years old because 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 take any other medicines.

In particular, tell 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 too much 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 with 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.
• Medicines that lower cholesterol, such as simvastatin, atorvastatin, rosuvastatin, and pravastatin.
• Medicines used to treat HIV infections, such as the antiretroviral efavirenz.

Taking Lupkynis with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 or in women of childbearing potential who are not using contraceptive methods.

Tell your doctor if you are breastfeeding. It is not known whether the medicine can pass into breast milk and affect your baby. Your doctor will advise you whether to stop treatment with this medicine while breastfeeding or to stop breastfeeding.

There is 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 capsules of Lupkynis contains 64.8 mg of ethanol, which is 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 soy lecithin

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

3. How to take Lupkynis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose of Lupkynis is three capsules twice a day by mouth. The capsules should be swallowed whole and can be taken with or without food.

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

This medicine should be used in combination with another immunosuppressive 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 tremors in one or more parts of the body).

If you forget to take Lupkynis

If you miss a dose, 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, simply skip that dose and take the next one at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Lupkynis

Do not stop treatment unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Serious side effects

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

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

• Infection symptoms (such as fever, body aches, feeling tired, cough or sneezing, nausea, vomiting, or diarrhea)

Common(may affect up to 1 in 10 people)

• New symptoms of nervous system or brain problems, such as seizures

Other side effects

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

• Upper chest infection
• Decrease in the number of red blood cells, which can make your skin pale and cause weakness or shortness of breath (anemia)
• Headache
• High blood pressure
• Cough
• Diarrhea
• Abdominal pain (stomach)
• Changes in kidney function that may reduce the amount of urine you produce and may cause new or worsening swelling in the legs or feet

Common(may affect up to 1 in 10 people)

• Infections, which can be bacterial, such as urinary tract infections, or viral, such as herpes
• Inflammation of the stomach and intestines
• Flu
• Increased potassium levels observed in blood tests
• Decreased appetite
• Tremors
• Nausea
• Abnormal swelling, bleeding, and/or inflammation of the gums
• Indigestion
• Hair loss
• Excessive and/or abnormal hair growth on any part of the body

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side 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 and blister after EXP. The expiry date refers to the last day of the month stated.

Store in the original blister to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are:

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

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

Processing aid: soy lecithin.

Appearance of the product and pack contents

Lupkynis 7.9 mg is presented as soft capsules of approximately 13 mm x 6 mm, pink/orange in color, packaged in blisters. Each blister contains 18 soft capsules. Each carton contains 180 or 576 soft capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT Amsterdam

Netherlands

Manufacturer

Millmount Healthcare Limited

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

Ireland

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:MM/AAAA.

Other sources of information

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