KAPRUVIA 50 micrograms/ml injectable solution

2. What you need to know before you use Kapruvia

Do not use Kapruvia

• if you are allergic to difelikefalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given Kapruvia if:

• you have high levels of potassium in your blood;
• you have or have had heart weakness or heart rhythm disorder;
• you have reduced function of the blood-brain barrier (such as brain cancer, or central nervous system cancer, or a central nervous system disease such as multiple sclerosis or dementia) as they may increase the risk of side effects;
• you are 65 years of age or older, as the likelihood of experiencing drowsiness due to the medicine increases;
• you are using medicines that may increase the risk of drowsiness or dizziness, such as:
  • medicines that slow down brain activity, such as those used to help with sleep disorders and anxiety;
  • medicines for treating allergies, colds, nausea and/or vomiting, called sedating antihistamines;
  • strong painkillers, called opioid analgesics.

Tell your doctor if you are taking any of these medicines.

Children and adolescents

Kapruvia is not recommended for use in children and adolescents under 18 years of age, as it has not been studied in these patients.

Other medicines and Kapruvia

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given Kapruvia.

No studies have been performed on the use of Kapruvia in pregnant women. It is not known whether Kapruvia may harm the fetus. Your doctor will tell you if you should use Kapruvia during pregnancy.

It is not known whether difelikefalin passes into breast milk. If you are breastfeeding, your doctor will tell you whether you should stop breastfeeding or stop using Kapruvia, taking into account the benefits of breastfeeding for the baby and Kapruvia for the mother.

Driving and using machines

Kapruvia may cause drowsiness and dizziness that may affect your ability to react. Do not drive or use machines if your ability to react is reduced or if you do not know how Kapruvia affects your ability to react.

Kapruvia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially “sodium-free”.

3. How to use Kapruvia

Your doctor will calculate the correct dose of Kapruvia for you based on your body weight. A doctor or nurse will give you Kapruvia by intravenous injection at the end of your dialysis session through the tube that connects you to the dialysis machine.

You will be given Kapruvia 3 times a week. This will increase to 4 times a week if you have a fourth dialysis session. It is not recommended to give more than 4 doses, even if you have more than 4 dialysis treatments in a week.

If you do not complete a dialysis treatment, your doctor will decide whether to give you Kapruvia after the unfinished dialysis session or wait until the next dialysis treatment. If you miss a dialysis treatment, you will be given your usual dose of Kapruvia at the next dialysis session.

It is expected that itching will decrease after 2-3 weeks of treatment with Kapruvia.

Patients with reduced liver function

No dose adjustment is needed in patients with mild or moderate reduced liver function.

Kapruvia is not recommended for use in patients with severe reduced liver function, as it has not been studied in these patients.

If you are given more Kapruvia than you should

This increases the risk of side effects, including those listed in section 4. Tell your doctor if you think this may have happened to you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in patients given this medicine:

Common, may affect up to 1 in 10 people:

• drowsiness
• disorders of skin sensitivity, such as tingling, prickling, burning, or numbness, reduced sense of touch or sensitivity

Uncommon, may affect up to 1 in 100 people:

• dizziness
• headache
• changes in mental status (alertness and clarity of thought), including confusion
• nausea, vomiting
• diarrhea

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via 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. Storage of Kapruvia

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 label and carton after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kapruvia

• The active substance is difelikefalin.

Each vial contains 50 micrograms of difelikefalin (as acetate) in 1 ml of solution.

• The other ingredients are acetic acid (for pH adjustment), sodium acetate trihydrate (for pH adjustment), sodium chloride, and water for injections. See section 2: “Kapruvia contains sodium”.

Appearance and pack of Kapruvia

Kapruvia is a clear, colorless, and particle-free solution (pH 4.5). It is provided in a glass vial with a rubber stopper, an aluminum seal, and a blue plastic flip-off cap.

Pack sizes of 3 and 12 vials.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer Marketing authorisation holder

Vifor Fresenius Medical Care Renal Pharma France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Manufacturer

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

To obtain information on this medicine, contact the marketing authorisation holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.