Idefirix

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Imlifidase

זמין מ:

Hansa Biopharma AB

קוד ATC:

L04AA

INN (שם בינלאומי):

imlifidase

קבוצה תרפויטית:

Immunosuppressants

איזור תרפויטי:

Desensitization, Immunologic; Kidney Transplantation

סממני תרפויטית:

Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

leaflet_short:

Revision: 4

מצב אישור:

Authorised

תאריך אישור:

2020-08-25

עלון מידע

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
IDEFIRIX 11 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
imlifidase
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Idefirix is and what it is used for
2.
What you need to know before you are given Idefirix
3.
How to use Idefirix
4.
Possible side effects
5.
How to store Idefirix
6.
Contents of the pack and other information
1.
WHAT IDEFIRIX IS AND WHAT IT IS USED FOR
Idefirix contains the active substance imlifidase, which belongs to a
group of medicines called
immunosuppressants. It is given before your kidney transplantation to
prevent the immune system
(your body's defences) from rejecting the donated kidney.
Idefirix works by breaking down a type of antibody in the body called
immunoglobulin G (IgG),
which is involved in destroying 'foreign' or harmful substances.
Imlifidase is a protein from a bacterium called
_Streptococcus pyogenes._
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IDEFIRIX
_ _
YOU MUST NOT BE GIVEN IDEFIRIX
-
If you are allergic to imlifidase or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have a severe infection.
-
If you have a blood disorder called thrombotic thrombocytopenic
purpura (TTP), that results in
blood clots forming in small blood vessels throughout the body.
WARNINGS AND PRECAUTIONS
Infusion reactions
Idefirix contains a protein and it can cause allergic reactions in
some people. You will receive
medicines t

מאפייני מוצר

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
Idefirix 11 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 11 mg imlifidase produced in
_Escherichia coli_
cells by recombinant DNA
technology.
After reconstitution and dilution, each mL of concentrate contains 10
mg imlifidase.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
The powder is a white cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Idefirix is indicated for desensitisation treatment of highly
sensitised adult kidney transplant patients
with positive crossmatch against an available deceased donor. The use
of Idefirix should be reserved
for patients unlikely to be transplanted under the available kidney
allocation system including
prioritisation programmes for highly sensitised patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be prescribed and supervised by specialist physicians
experienced in the
management of immunosuppressive therapy and of sensitised renal
transplant patients.
Imlifidase is restricted to hospital use only.
Posology
The dose is based on patient body weight (kg). The recommended dose is
0.25 mg/kg administered as
a single dose preferably within 24 hours before transplantation. One
dose is adequate for crossmatch
conversion in the majority of patients but, if needed, a second dose
can be administered within
24 hours after the first dose.
After treatment with imlifidase, crossmatch conversion from positive
to negative should be confirmed
before transplantation (see section 4.4).
Premedication with corticosteroids and antihistamines should be given
to reduce the r