IDEFIRIX 11 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMLIFIDASE

Available from:

MEDISON PHARMA LTD

ATC code:

L04AA41

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IMLIFIDASE 11 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

HANSA BIOPHARMA AB, SWEDEN

Therapeutic area:

IMLIFIDASE

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.

Authorization date:

2022-03-21

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
IDEFIRIX
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 risk of infusion
reactions in accordance with transplant centre routines.
2
Since respiratory tract infections are the most common infections in
patients with
hypogammaglobulinemia, prophylactic oral antibiotics covering
respiratory tract pathogens should be
added to the standard of care for 4 weeks (see section 4.4).
Patients treated with imlifidase sh