KORSUVA

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

DIFELIKEFALIN AS ACETATE

Verfügbar ab:

CTS LTD

ATC-Code:

V03AX04

Darreichungsform:

SOLUTION FOR INJECTION

Zusammensetzung:

DIFELIKEFALIN AS ACETATE 50 MCG / 1 ML

Verabreichungsweg:

I.V

Verschreibungstyp:

Required

Hergestellt von:

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA, FRANCE

Therapiebereich:

DIFELIKEFALIN

Anwendungsgebiete:

Korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis

Berechtigungsdatum:

2023-06-27

Gebrauchsinformation

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
– 1986
The medicine is dispensed with a doctor’s prescription only
KORSUVA
SOLUTION FOR INJECTION 50 MICROGRAMS/ 1 ML
ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each 1 ml of solution contains 50 mcg of difelikefalin.
Inactive and allergenic ingredients in the preparation
–
for the list of inactive and allergenic
ingredients in the preparation - see Section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Korsuva is used to treat moderate to severe itching related to chronic
kidney disease in adults
who undergo hemodialysis.
THERAPEUTIC GROUP: All other therapeutic products
Korsuva contains the active substance difelikefalin.
Korsuva acts on targets in the body called kappa-opioid receptors,
which are involved in
controlling the perception of itching. By stimulating these receptors
on nerve and immune cells
outside the brain, Korsuva relieves the itching sensation caused by
chronic kidney disease.
The active substance difelikefalin does not cross the blood-brain
barrier (a natural barrier
between blood vessels and the brain), reducing the risk of side
effects.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to difelikefalin, or to any of the other
ingredients contained in
the medicine (see Section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
Before the treatment with Korsuva, tell the doctor or nurse if:

you have an increased level of potassium in your blood

you have or have had heart weakness or arrhythmia (irregular
heartbeat)

you have reduced function of the blood-brain barrier (for example, due
to cancer in the br

Fachinformation

2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kosruva 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
Kosruva 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
Korsuva should be restricted for in-centre haemodialysis use only.
Korsuva 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
1.0
105
–
114
1.1
115
–
124
1.2
125
–
134
1.3
135
–
144
1.4
145
–
154
1.5
155
–
164
1.6
165
–
174
1.7
175
–
184
1.8
185
–
194
1.9
≥
195
2.0
1
More than 1 vial may be necessary if an injection volume of more than
1 mL is required.
An effect of difelik