Инструкция по применению KAPRUVIA
Содержание инструкции
Kapruvia 50 micrograms/mL injectable solution
difelikefalin
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
encountered during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.
Read this leaflet carefully before 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 dangerous.
If any adverse effects occur, including those not listed in this leaflet, tell 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 you use 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 is Kapruvia and what is it used for
Kapruvia contains the active substance difelikefalin. It is used to treat itchingin adults with chronic kidney disease who require dialysis to clean their blood.
Kapruvia works on receptors in the human body called kappa opioid receptors involved in controlling the
perception of itching. By stimulating these receptors present on nerves and immune cells
outside the brain, Kapruvia relieves the sensation of itching 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 side effects.
2. What you need to know before using 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 using Kapruvia in the following cases:
- you have an increased level of potassium in your blood
- you have or have had in the past heart weakness or irregular heartbeat
- 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 side effects
- you are 65 years of age or older, because the medicine is more likely to cause drowsiness
- you are taking medicines that may increase the risk of drowsiness or dizziness such as:
- medicines that slow down brain activity such as those that help with sleep disorders and anxiety
- medicines to treat allergies, colds, nausea and/or vomiting called sedating antihistamines
- strong painkillers, called opioid analgesics Talk to 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
these patients.
Other medicines and Kapruvia
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor for advice before using Kapruvia.
Kapruvia has not been studied in pregnant women. It is not known whether Kapruvia can harm the
unborn child. Your doctor will discuss with you to determine whether you should use Kapruvia during
pregnancy.
It is not known whether difelikefalin can pass into breast milk. If you are breastfeeding, your doctor will
recommend whether to stop breastfeeding or use Kapruvia, based on the benefit of breastfeeding for the
baby and of Kapruvia for the mother.
Driving and using machines
Kapruvia can cause drowsiness and dizziness which may affect your ability to react.
Do not drive vehicles or use machines if your ability to react is reduced or if you do not know the
effects of Kapruvia on your ability to react.
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 right dose of Kapruvia for you based on your body weight. It will be given
as an intravenous injection by a doctor or nurse at the end of dialysis treatment through the
line 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 in case of a
fourth dialysis session. More than 4 doses are not recommended even if the number of dialysis treatments in
a week is greater than 4.
If a dialysis treatment is not completed, the doctor will decide whether it is best to administer
Kapruvia after the incomplete dialysis session or wait for the next dialysis treatment.
If a dialysis treatment is not performed, the usual dose of Kapruvia will be given on
the occasion of the next dialysis treatment.
It is expected that itching will decrease after 2-3 weeks of treatment with Kapruvia.
Patients with impaired liver function
No dose adjustments are required in patients with mild or moderate impaired liver function.
Kapruvia is not recommended for patients with severe impaired liver function, as
use has not been studied in such patients.
If you receive more Kapruvia than you should
This increases the occurrence of the undesirable effects listed in section 4. Inform your doctor if
you think this is the case.
If you have any questions about 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 observed in patients receiving this medicine:
Commonmay affect up to 1 in 10 people:
- drowsiness
- disturbance of skin sensations such as tingling, prickling, burning or numbness, reduced sensation or sensitivity
Uncommonmay affect up to 1 in 100 people:
- dizziness
- headache
- alterations in mental state (lucidity and clarity of thought), including confusion
- nausea, vomiting
- diarrhea
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 which is stated on the label and the packaging after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
6. Contents of the pack and other information
What Kapruvia contains
- The active ingredient 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 Kapruvia and contents of the pack
Kapruvia is a clear, colorless solution free from particles (pH 4.5). The solution is supplied
in a glass vial closed with a rubber stopper and an aluminum seal with a blue plastic snap-on 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 on this medicine, contact the marketing authorisation holder.
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu .

- Страна регистрации
- Форма выпускаInjectable solution, 50 ?g / mL
- Код АТХV03AX04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KAPRUVIAФорма выпуска: Injectable solution, 0,5 MG/5 MLДействующее вещество: флумазенилПроизводитель: CHEPLAPHARM ARZNEIMITTEL GMBHОтпускается по рецептуФорма выпуска: Compressed medical gas, 200 BARДействующее вещество: medical airПроизводитель: AIR LIQUIDE SANTE (INTERNATIONAL)Отпускается по рецептуФорма выпуска: Inhalation gas, 200 BARДействующее вещество: medical airПроизводитель: LINDE MEDICALE SRLОтпускается по рецепту
Аналоги KAPRUVIA в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог KAPRUVIA в Испания
Аналог KAPRUVIA в Польша
Врачи онлайн по KAPRUVIA
Обсудите применение KAPRUVIA и возможные следующие шаги — по оценке врача.
Получите рецепт на KAPRUVIA онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
KAPRUVIA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KAPRUVIA — difelikefalin. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KAPRUVIA производится компанией VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения KAPRUVIA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить KAPRUVIA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (difelikefalin) включают ANEXATE, ARIA AIR LIQUIDE SANITA', ARIA LINDE MEDIKALE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















