Kapruvia

Package leaflet: Information for the patient

Kapruvia 50 micrograms/mL injectable solution

difelikefalin
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.
Contents of this leaflet

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

1. What Kapruvia is and what it is used for

Kapruvia contains the active substance difelikefalin. It is used to treat pruritus in adults with chronic kidney disease who require dialysis to clean the blood.
Kapruvia acts on receptors in the human body called kappa opioid receptors, which are involved in controlling the perception of pruritus. By stimulating these receptors located on nerves and immune cells outside the brain, Kapruvia reduces the sensation of pruritus caused by chronic kidney disease.
The active substance difelikefalin does not cross the blood-brain barrier (the natural protective barrier between blood vessels and the brain), which reduces the risk of unwanted side effects.

2. What you should know before using Kapruvia

Do not use Kapruvia
if you are allergic to difelikefalin or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or nurse before using Kapruvia if any of the following apply to you:

• you have increased potassium levels in the blood
• you have or have previously had heart weakness or heart rhythm disorder
• you have reduced function of the blood-brain barrier (such as brain or central nervous system cancer, or a central nervous system disease such as multiple sclerosis or dementia), as this may increase the risk of undesirable effects
• you are aged 65 years or older, as you are more likely to experience drowsiness from the medicine
• you are taking medicines that could increase the risk of drowsiness or dizziness, such as:
  • medicines that slow down brain activity, such as those used for sleep disorders and anxiety
  • medicines used to treat allergies, colds, nausea and/or vomiting called sedating antihistamines
  • strong painkillers called opioid analgesics. Please consult your doctor if you are taking any of these medicines.

Children and adolescents
Kapruvia is not recommended for children under 18 years of age, as it has not been studied in
such patients.
Other medicines and Kapruvia
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before using Kapruvia.
Kapruvia has not been studied in pregnant women. It is not known whether Kapruvia could harm the unborn baby. Your doctor will discuss with you whether you should use Kapruvia during pregnancy.
It is not known whether difelikefalin passes into breast milk. If you are breastfeeding, your doctor will advise you whether to discontinue breastfeeding or to use Kapruvia, based on the benefit of breastfeeding for the child and of Kapruvia for the mother.
Driving and using machines
Kapruvia may cause drowsiness and dizziness, which could affect your reaction ability.
Do not drive or operate machinery if your reaction ability is impaired or if you are unsure of the effects of Kapruvia on your reaction ability.
Kapruvia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
“sodium-free”.

3. How to use Kapruvia

Your doctor will determine the correct dose of Kapruvia for you based on your body weight. It will be administered
as an intravenous injection by a doctor or nurse at the end of your dialysis treatment through
the tubing used to connect you to the dialysis machine.
Kapruvia will be given 3 times a week. It may be increased to 4 times a week if you have a fourth dialysis session.
More than 4 doses are not recommended, even if the number of dialysis treatments in a week exceeds 4.
If a dialysis treatment is not completed, your doctor will decide whether it is better to administer
Kapruvia after the incomplete dialysis session or to wait until the next dialysis treatment.
If a dialysis treatment is not performed, your usual dose of Kapruvia will be administered at the time of your next dialysis session.
A reduction in itching is expected after 2–3 weeks of treatment with Kapruvia.
Patients with impaired liver function
Dose adjustments are not required in patients with mild or moderate liver impairment. Kapruvia is not recommended for patients with severe liver impairment, as its use has not been studied in such patients.
If you receive more Kapruvia than you should
This increases the likelihood of experiencing the side effects listed in section 4. Inform your doctor if
you think this applies to you.
If you have any questions about the use of this medicine, consult 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 observed in patients receiving this medicine:
Common – may affect up to 1 in 10 people:

• somnolence
• disturbances in skin sensation such as tingling, pricking, burning, or numbness, reduced sensation or sensitivity

Uncommon – may affect up to 1 in 100 people:

• dizziness

• headache

• alterations in mental state (clarity and lucidity of thought), including confusion

• nausea, vomiting

• diarrhoea

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kapruvia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.

6. Package contents and other information

What Kapruvia contains

• The active substance is difelikefalin. Each vial contains 50 micrograms of difelikefalin (as acetate) in 1.0 mL of solution.
• The other excipients are acetic acid (for pH adjustment), sodium acetate trihydrate (for pH adjustment), sodium chloride, water for injections. See section 2 “Kapruvia contains sodium”.

Description of the appearance of Kapruvia and package contents
Kapruvia is a clear, colourless solution free from particles (pH 4.5). The solution is supplied in a glass vial closed with a rubber stopper and an aluminium seal with a blue plastic snap-off cap.
Pack sizes of 3 and 12 vials.
Not all pack sizes may be marketed.

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

For further information about this medicinal product, please contact the Marketing Authorisation Holder.
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu