Posology : מינונים

4.2    Posology and method of administration

Treatment should be prescribed and supervised by specialist physicians experienced in themanagement 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 asa 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.
Since respiratory tract infections are the most common infections in patients with hypogammaglobulinemia, prophylactic oral antibiotics covering respiratory tract pathogens should beadded to the standard of care for 4 weeks (see section 4.4).

Patients treated with imlifidase should, in addition, receive standard of care induction T-cell depletingagents with or without B-cell depleting agents (see section 5.1), i.e. imlifidase does not eliminate the need for standard of care immunosuppressive therapy.

Special populations

Elderly patients
Data on the use in patients older than 65 years are limited, but there is no evidence to suggest that dose adjustment is required in these patients.

Hepatic impairment
The safety and efficacy of imlifidase in patients with moderate or severe hepatic impairment have not been established. No data are available.

Paediatric population
The safety and efficacy of imlifidase in children and adolescents 0 to 18 years old have not been established. No data are available.

Method of administration

Idefirix is for intravenous use only following reconstitution and dilution.
The entire, fully diluted infusion should be administered over a period of 15 minutes and must be administered with an infusion set and a sterile, inline, non-pyrogenic, low protein binding filter (poresize of 0.2 μm). Following administration, it is recommended that the intravenous line is flushed withinfusion fluid to ensure administration of the complete dose. Do not store any unused portion of the solution for infusion for re-use.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.