Nulojix
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-12-2023
Fachinformation
(SPC)
12-12-2023
Öffentlichen Beurteilungsberichts
(PAR)
04-06-2021
Wirkstoff:
belatacept
Verfügbar ab:
Bristol-Myers Squibb Pharma EEIG
ATC-Code:
L04AA28
INN (Internationale Bezeichnung):
belatacept
Therapiegruppe:
Immunosuppressants
Therapiebereich:
Graft Rejection; Kidney Transplantation
Anwendungsgebiete:
Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.
Produktbesonderheiten:
Revision: 20
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2011-06-17
Gebrauchsinformation
34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
NULOJIX 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BELATACEPT
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 pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What NULOJIX is and what it is used for
2.
What you need to know before you use NULOJIX
3.
How to use NULOJIX
4.
Possible side effects
5.
How to store NULOJIX
6.
Contents of the pack and other information
1.
WHAT NULOJIX IS AND WHAT IT IS USED FOR
NULOJIX contains the active substance belatacept which belongs to a
group of medicines called
immunosuppressants. These are medicines that reduce the activity of
the immune system, the body's
natural defences.
NULOJIX is used in adults to prevent the immune system from attacking
your transplanted kidney and
causing transplant rejection. It is used with other immunosuppressive
medicines, including
mycophenolic acid and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NULOJIX
DO NOT USE NULOJIX
IF YOU ARE ALLERGIC
to belatacept or any of the other ingredients of the medicine (listed
in
section 6). Allergic reactions related to belatacept use have been
reported in the clinical studies.
IF YOU HAVE NOT BEEN EXPOSED TO THE EPSTEIN-BARR VIRUS
(EBV) or are uncertain of previous
exposure, you must not be treated with NULOJIX. EBV is the virus that
causes glandular fever.
If you have not been exposed to it, you are at a higher risk of
getting a type of cancer called
post-transplant lymphoproliferative disorder (PTLD). If you are not
sure if you have been
infected with the virus before, ask your doctor.
WARNINGS AND PRECAUTIONS
Post-transplant lymphoproliferative disorder
Treatment with NULOJIX increases th
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NULOJIX 250 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of belatacept.
After reconstitution, each ml of concentrate contains 25 mg
belatacept.
Belatacept is a fusion protein produced in Chinese hamster ovary cells
by recombinant DNA
technology.
Excipient with known effect
Each vial contains 0.55 mmol sodium.
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 to off-white whole or fragmented cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NULOJIX, in combination with corticosteroids and a mycophenolic acid
(MPA), is indicated for
prophylaxis of graft rejection in adult recipients of a renal
transplant (see section 5.1 for data on renal
function).
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 renal transplant
patients.
Belatacept has not been studied in patients with Panel Reactive
Antibody (PRA) > 30% (who often
require increased immunosuppression). Because of the risk of a high
total burden of
immunosuppression, belatacept should only be used in these patients
after consideration of alternative
therapy (see section 4.4).
Posology
_Initiation at the time of transplantation _
For transplant recipients receiving NULOJIX treatment from time of
transplantation (“newly
transplanted patients”), the addition of an interleukin-2 (IL-2)
receptor antagonist is recommended.
The recommended dose is based on patient body weight (kg). The dose
and treatment frequency is
given below.
3
TABLE 1:
DOSE OF BELATACEPT FOR RENAL TRANSPLANT RECIPIENTS
INITIAL PHASE
DOSE
Day of transplantation, prior to implantation (Day 1)
10 mg/kg
Day 5, Day 14 and Day 28
10 mg/kg
End of Week 8 and Week 12 after transplantation
10 mg/k
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