DARZALEX + DARZALEX FASPRO - Use in Solid Organ Transplant Rejection

SUMMARY

• DARZALEX for intravenous (IV) use and DARZALEX FASPRO for subcutaneous (SC) use are not approved by the regulatory agencies for the treatment of patients with solid organ transplant rejection.
• Johnson & Johnson does not recommend the use of DARZALEX or DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
• Citations for several case reports and analyses of patients with transplant rejection who received DARZALEX or DARZALEX FASPRO are referenced below.

Heart Transplant

• Tuta RS, Touzot F, Laroussi NA, et al. Daratumumab in heart transplantation: a pilot study in a pediatric and young adult series. Pediatr Transplant. 2025;29(7):e70166. doi:10.1111/petr.70166.
• Milligan C, Wong A, Bastardi H, et al. Daratumumab for anti-HLA antibody desensitization and antibody mediated rejection in pediatric heart transplant patients. Pediatr Transplant. 2025;29(5):e70106. doi:10.1111/petr.70106.
• Konduri A, Flynn KE, Huebschman A, et al. Donor-derived cell-free DNA as a marker for the efficacy of daratumumab in patients with antibody-mediated rejection post-heart transplantation: a case series. Pediatr Transplant. 2025;29(6):e70168. doi:10.1111/petr.70168.
• Aguilera Agudo C, Gómez Bueno M, Krsnik Castello I. Daratumumab for antibody-mediated rejection in heart transplant-a novel therapy: successful treatment of antibody-mediated rejection. Transplantation. 2021;105(3):e30-e31. doi:10.1097/TP.0000000000003505.

Kidney Transplant

• Connolly H, Watson A, Wynd M, et al. Daratumumab for treatment of acute antibody-mediated rejection in a pediatric kidney transplant recipient. Pediatr Transplant. 2025;29(5):e70116. doi:10.1111/petr.70116.
• Lye WC, Loh HL. Anti-CD38 daratumumab treatment of chronic active antibody-mediated kidney allograft rejection. Kidney Int Rep. 2025;10(10):3506-3515. doi:10.1016/j.ekir.2025.07.009.
• Guo Z, Sa R, Zhao D, et al. Daratumumab followed by tocilizumab for treatment of late antibody-mediated rejection in renal transplant recipients with high or moderate levels of de novo donor-specific antibodies: a pilot study. BMC Nephrol. 2025;26(1):19. doi:10.1186/s12882-025-03951-5.
• Ollé J, Larque AB, de Larrea CF, et al. Searching for the minimum required dose of daratumumab to induce effective plasma cell depletion in antibody-mediated rejection of the kidney graft: a case report. J Nephrol. 2025;38(2):739-744. doi:10.1007/s40620-024-02182-5.
• Knödl L, Büttner-Herold M, Götz M, et al. Acute rejection with DSA-negative severe microvascular inflammation in a kidney transplant recipient with an isolated DPB1*04-mismatch successfully stabilised with daratumumab. HLA. 2026;107(1):e70560. doi:10.1111/tan.70560.
• de Nattes T, Kaveri R, Farce F, et al. Daratumumab for antibody-mediated rejection: is it time to target the real culprit?. Am J Transplant. 2023;23(12):1990-1994. doi:10.1016/j.ajt.2023.06.018.
• Süsal CC, Kraft L, Ender A, et al. Blood group-specific apheresis in combination with daratumumab as a rescue therapy of acute antibody-mediated rejection in a case of ABO- and human leukocyte antigen-incompatible kidney transplantation. SAGE Open Med Case Rep. 2023;11:2050313X231211050. doi:10.1177/2050313X231211050.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 23 June 2026. The search was limited to publications from 2020 to present.