Kapruvia

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

difelikefalin

Tillgänglig från:

Vifor Fresenius Medical Care Renal Pharma France

ATC-kod:

V03AX

INN (International namn):

difelikefalin

Terapeutisk grupp:

All other therapeutic products

Terapiområde:

Pruritus

Terapeutiska indikationer:

Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1).

Produktsammanfattning:

Revision: 1

Bemyndigande status:

Authorised

Tillstånd datum:

2022-04-25

Bipacksedel

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KAPRUVIA 50 MICROGRAMS/ML SOLUTION FOR INJECTION
difelikefalin
This medicine is subject to additional monitoring. This 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 USING 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 nurse.
•
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 nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN 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 KAPRUVIA IS AND WHAT IT IS USED FOR
Kapruvia contains the active substance difelikefalin. It is used to
TREAT ITCHING
in adults with chronic
kidney disease who need dialysis to clean their blood.
Kapruvia works at targets in the body called kappa-opioid receptors
which are involved in controlling
the perception of itching. By stimulating these receptors on nerves
and immune cells outside the brain,
Kapruvia relieves the sensation of itch caused by chronic kidney
disease. The active substance
difelikefalin does not pass 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 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).
22
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Kapruvia 50 micrograms/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 1 mL contains 50 micrograms difelikefalin (as acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, free from particles (pH 4.5).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kapruvia is indicated for the treatment of moderate-to-severe pruritus
associated with chronic kidney
disease in adult patients on haemodialysis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kapruvia should be restricted for in-centre haemodialysis use only.
Kapruvia is intended for use by healthcare professionals experienced
in the diagnosis and treatment of
conditions for which difelikefalin is indicated. Causes of pruritus
other than chronic kidney disease
should be excluded before initiating treatment with difelikefalin.
Posology
Difelikefalin is administered 3 times per week by intravenous bolus
injection into the venous line of
the dialysis circuit at the end of the haemodialysis treatment during
rinse-back or after rinse-back.
The recommended dose of difelikefalin is 0.5 micrograms/kg dry body
weight (i.e., the target
postdialysis weight). The total dose volume (mL) required from the
vial should be calculated as
follows: 0.01 × dry body weight (kg), rounded to the nearest tenth
(0.1 mL). For patients with a dry
body weight equal to or above 195 kg the recommended dose is 100
micrograms (2 mL). Injection
volumes are detailed in the table below:
WEIGHT RANGE
(Dry body weight in kg)
INJECTION VOLUME
1
(mL)
40 – 44
0.4
45 – 54
0.5
55 – 64
0.6
65 – 74
0.7
75 – 84
0.8
85 – 94
0.9
3
95 – 104
1