Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Hansa Biopharma AB, P.O. Box 785, 220 07 Lund, Sweden
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.
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.
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.
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 should, in addition, receive standard of care induction T-cell depleting agents 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.
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.
The safety and efficacy of imlifidase in patients with moderate or severe hepatic impairment have not been established. No data are available.
The safety and efficacy of imlifidase in children and adolescents 0 to 18 years of age have not been established. No data are available.
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 (pore size of 0.2 μm). Following administration, it is recommended that the intravenous line is flushed with infusion 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.
There is no experience with doses higher than the recommended. In the event of an overdose, the patient should be monitored closely and treated symptomatically. No specific antidote exists, but depletion of IgG can be restored by administration of IVIg.
Unopened vial:
1 year.
After reconstitution:
The reconstituted solution should be transferred from the vial to the infusion bag immediately.
After dilution:
Chemical and physical in-use stability after reconsitution and dilution has been demonstrated for 24 hours at 2-8°C and for 4 hours at 25°C during this period.
From a microbiological point of view, unless the method of reconstituting and dilution precludes the risk for microbial contamination, the product should be used immediately.
If not used immediately, in-use storage conditions are the responsibility of the user. The solution should be stored protected from light.
Store in a refrigerator (2-8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after reconstitution or dilution of the medicinal product, see section 6.3.
Idefirix is supplied in a vial (Type I glass) with a stopper (bromobutyl rubber) and flip off seal (aluminum).
Pack sizes of 1 vial or 2 × 1 vials.
Introduce 1.2 mL of sterile water for injections into the Idefirix vial, taking care to direct the water to the glass wall and not into the powder.
Swirl the vial gently for at least 30 seconds to dissolve the powder completely. Do not shake so as to minimise the likelihood of forming foam. The vial will now contain imlifidase 10 mg/mL and up to 1.1 mL of the solution can be withdrawn.
The reconstituted solution should be clear and colourless. Do not use if particles are present or the solution is discoloured. It is recommended to transfer the reconstituted solution from the vial to the infusion bag immediately.
Slowly add the correct amount of reconstituted imlifidase solution to an infusion bag containing 50 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion. Invert the infusion bag several times to thoroughly mix the solution. The infusion bag should be protected from light. A sterile, inline, non-pyrogenic, low protein binding filter (pore size of 0.2 μm) infusion set must be used. For further information on administration see section 4.2.
Prior to use the solution for infusion should be inspected visually for particulate matter or discolouration. Discard the solution if any particulate matter or discolouration is observed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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