Prospect: information for the patient

Lupkynis 7.9 mg soft capsules

voclosporin

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

The active ingredient of Lupkynis belongs to a group of medicines known as calcineurin inhibitors that can be used to control the body's immune response (immunosuppressants). In lupus, the immune system (the body's natural defenses) attacks parts of its own body by mistake, including the kidneys (lupus nephritis). By reducing the immune system's response, the medicine reduces kidney inflammation and decreases symptoms such as, for example, swelling in the legs, ankles, or feet, high blood pressure, and fatigue, as well as improving kidney function.

Do not take Lupkynis:

• If you are allergic to voclosporin or any of the other ingredients in this medication (listed in section 6).
• If you are taking other medications 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lupkynis if you have any of the following situations:

• If your kidney disease worsens, you may need to change the dose of this medication. Your doctor will regularly check the functioning of your kidneys.
• 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 infection with parvovirus B19 or previous administration of treatments that may cause PRCA.
• If you have or develop high blood pressure. Your doctor will take your blood pressure every two weeks during the first month and, thereafter, regularly. You may be given a medication to lower your blood pressure or told to stop taking this medication.
• This medication may increase the risk of nervous system disorders such as, for example, headaches, tremors, changes in vision, seizures, confusion, or weakness in one or more limbs. If you experience any of these new symptoms or an exacerbation of existing ones, your doctor may consider suspending or reducing the dose of this medication (see section 4).
• If you are planning to be vaccinated or have been vaccinated in the last 30 days. This medication may affect the response to vaccination, and vaccination during treatment with this medication may be less effective.
• If you have previously experienced potentially life-threatening allergic reactions (anaphylactic reactions) to soy or peanuts, do not take this medication.

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

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

This medication may affect the electrical activity of your heart (prolongation of the QT interval). This may lead to severe arrhythmias. The first symptoms are dizziness and fainting.

Sunlight and ultraviolet light

This medication may increase the risk of developing certain types of skin cancer. You should avoid or limit your exposure to sunlight and ultraviolet light using protective clothing and applying a high-factor sunscreen frequently.

Infections

This medication may increase the 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 if you should stop taking this medication (see section 4).

Children and adolescents

Do not take this medication if you are under 18 years old because it has not been studied in this age group.

Older patients

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

Other medications and Lupkynis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking:

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

Taking Lupkynis with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended during pregnancy, nor in women of childbearing age who are not using contraceptive methods.

Inform your doctor if you are breastfeeding. It is unknown whether the medication may pass into breast milk and affect your baby. Your doctor will advise you whether to stop taking this medication while breastfeeding or to stop breastfeeding.

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

Driving and operating machinery

Lupkynis is not expected to have any effect on your ability to drive and operate machinery.

Lupkynis contains alcohol

This medication 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 contained in this medication has no perceptible effect.

Lupkynis contains sorbitol

This medication contains 28.7 mg of sorbitol in each capsule.

Lupkynis may contain soy lecithin

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

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

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

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

This medication should be used in combination with another immunosuppressant medication 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 (uncontrolled shaking or 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 and within 4 hours of the missed dose. If more than 4 hours have passed since the time you normally take the medication, simply skip that dose and take the next one at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Lupkynis

Do not interrupt treatment unless your doctor tells you to.

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

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

Severe side effects

If any of these cases occur, seek immediate medical attention, 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)

• Signs of infection (such as fever, body aches, feeling tired, cough, 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 respiratory tract infection
• Reduction in the number of red blood cells, which may cause pale skin and weakness or shortness of breath (anemia)
• Headache
• Increased blood pressure
• Cough
• Diarrhea
• Abdominal pain
• Changes in renal function that may 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)

• Infections, which may be bacterial, such as urinary tract infections, or viral, such as herpes
• Stomach and intestinal inflammation
• Influenza
• Increased levels of potassium observed in blood tests
• Loss of appetite
• Tremors
• Nausea
• Abnormal swelling, bleeding, and/or inflammation of the gums
• Indigestion
• Hair loss
• Excessive and/or abnormal hair growth in any part of the body

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Store in the original blister pack to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Lupkynis

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

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

Soft capsule coating: gelatin, sorbitol, glycerin, purified water, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

Processing aid:soy lecithin.

Appearance of the product and contents of the package

Lupkynis 7.9 mg is presented in the form of soft pink/orange capsules of approximately 13 mm × 6 mm packaged in blisters. Each blister contains 18 soft capsules. Each carton contains 180 or 576 soft capsules.

Only some package sizes may be commercially available.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT Amsterdam

Netherlands

Responsible for manufacturing

Millmount Healthcare Limited

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

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:MM/YYYY.

Other sources of information

More detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.There are also links to other websites about rare diseases and orphan drugs.