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Imlifidase parenteral

Updated 2 Feb 2023 | Imlifidase


Infusion of imlifidase.

These products have been produced by recombinant technology using E.coli.

Drugs List

  • IDEFIRIX 11mg powder for concentrate for soln for infusion vial
  • imlifidase 11mg powder for solution for infusion vial
  • Therapeutic Indications


    Desensitisation treatment for highly sensitised kidney transplant patients

    Treatment for desensitisation of highly sensitised adult kidney transplant patients with a positive crossmatch against an available donor.


    0.25 mg/kg administered as a single dose preferably within 24 hours of transplantation.

    A second dose can be administered within 24 hours after the first dose.

    A confirmation of crossmatch conversion from positive to negative is required before transplantation.


    Imlifidase is for intravenous use only.

    The fully diluted infusion should be administered over a period of 15 minutes.

    It is recommended that the intravenous line is flushed with infusion fluid to ensure administration of the complete dose.


    Children under 18 years
    Uncontrolled systemic infection
    Thrombotic thrombocytopenic purpura (TTP)

    Precautions and Warnings

    Concomitant medication consider washout period, see prescribing information
    Patients over 65 years
    Moderate hepatic impairment

    Disease reactivation may occur in patients with latent TB
    Respiratory tract pathogen prophylaxis required for 4 weeks post therapy
    Concomitant medication consider washout period: See prescribing information
    Consider premedication with antihistamine and/or corticosteroid
    Ensure access to facilities to perform biopsy in case AMR is suspected
    Treatment to be prescribed under the supervision of a specialist
    Monitor human leukocyte antigen (HLA) antibodies
    Monitor serum or plasma creatinine
    Interrupt therapy/reduce infusion rate if infusion-related reactions occur
    May reduce vaccinations effectiveness for up to 4 weeks following treatment
    Discontinue if serious allergic or anaphylactic reaction occurs
    Hospital use only

    Considerations should be given to a temporary reduction of IgG by imlifidase. Patients not transplanted after imlifidase treatment will still require prophylactic oral antibiotics for respiratory tract infections for 4 weeks.

    Patients should receive standard of care induction T-cell depleting therapy with or without memory B-cell depleting therapies, however this may increase the risk of reactivation of live-attenuated vaccines and latent tuberculosis.

    Patients with high levels of donor-specific antibodies (DSA) before transplantation are more likely to experience early antibody-mediated rejection (AMR) that requires intervention. In clinical studies, 30% of patients developed AMR and were successfully managed with standard treatment. However, it is crucial that the clinician is experienced in managing sensitised patients and that resources to diagnose and treat acute AMRs are in place.

    Influence of anti-imlifidase antibodies (ADA) on efficacy and safety of a second imlifidase dose within 24 hours of the first is negligible as production of ADA has not yet started.

    Crossmatch conversion confirmation
    When using complement-dependent cytotoxicity crossmatch (CDCXM) the following needs to be considered to avoid false positive results:

    IgM has to be inactivated to be able to specifically assess the cytotoxic capacity of IgG.

    If unavoidable, the use of an anti-human globulin (AHG) step requires confirmation that the AHG is directed against the Fc-part and not the Fab-part of IgG.

    There is very limited experience in patients with a confirmed positive T-cell complement-dependent cytotoxicity (CDC) crossmatch test.

    Pregnancy and Lactation


    Imlifidase is contraindicated during pregnancy.

    The manufacturer advises that imlifidase should be avoided during pregnancy as a precautionary measure.

    Animal studies did not indicate any harmful effects to embryonic and foetal development.


    Imlifidase is contraindicated during breastfeeding.

    The manufacturer advises that it is unknown whether imlifidase is excreted in human milk and a risk to the child cannot be excluded.

    Side Effects

    Abdominal infection
    Adenovirus infection
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Bacterial infection
    Catheter related infection
    Feeling hot
    Infusion related reaction
    Infusion site pain
    Parvovirus B19 infection
    Post operative wound infection
    Postural dizziness
    Sinus tachycardia
    Solid organ graft rejection
    Upper respiratory tract infection
    Urinary tract infections
    Viral infection
    Visual disturbances
    Wound infection


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2021

    Reference Sources

    Summary of product characteristics: Idefirix 11mg powder for concentrate for solution for infusion. Hansa Biopharma AB. Revised August 2020.

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