Desensitisation treatment of highly sensitised adult kidney transplant patients

Active Ingredient: Imlifidase

Indication for Imlifidase

Therapeutic intent: Neo-adjuvant intent

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

For this indication, competent medicine agencies globally authorize below treatments:

0.25 mg/kg administered as a single dose

Dosage regimens

Intravenous, 0.25 milligrams imlifidase per kilogram of body weight, one dose.

Detailed description

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.

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.

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

Active ingredient

Imlifidase

Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that cleaves the heavy chains of all human IgG subclasses but no other immunoglobulins. The cleavage of IgG leads to elimination of Fc-dependent effector functions, including CDC and antibody-dependent cell-mediated cytotoxicity (ADCC). By cleaving all IgG, imlifidase reduces the level of DSA, thus enabling transplantation.

Read more about Imlifidase

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