G-CSF for solid organ transpalntation – pro
Nivestym is a brand name for the prescription drug filgrastim-aafi, a biosimilar to the biologic drug Neupogen. In the absence of clinical history and the likelihood that this drug is being requested off-label for a cardiac reason, for CMV, and no documentation of neutropenia, I cannot support approval. In fact. G-CSF can trigger the reactivation and dissemination of latent CMV in certain patients and acute rejection; some studies suggest that this is caused by neutrienia and not G-CSF being used to treat it..
Neutropenia is a common complication after heart transplantation, primarily caused by immunosuppressive medications like mycophenolate mofetil and certain anti-viral prophylaxis drugs, as well as by infections like CMV. It increases the risk of infection and can be a serious complication requiring close monitoring and management, which may include temporarily stopping certain medications, adjusting the immunosuppression regimen, or using growth factors to boost white blood cell recovery.
A recent comparative trial concluded that G-CSF may be helpful to improve outcomes (Grasso et al). Other studies in other types of solid organ transplantation did not reach the same conclusion, and some find a poorer outcome.
Smith MS, Goldman DC, Bailey AS, Pfaffle DL, Kreklywich CN, Spencer DB, Othieno FA, Streblow DN, Garcia JV, Fleming WH, Nelson JA. Granulocyte-colony stimulating factor reactivates human cytomegalovirus in a latently infected humanized mouse model. Cell Host Microbe. 2010 Sep 16;8(3):284-91. doi: 10.1016/j.chom.2010.08.001. PMID: 20833379; PMCID: PMC2945885.
Sandal, Shaifali1; Yao, Han1; Alam, Ahsan1; D’Arienzo, David1; Baran, Dana1; Cantarovich, Marcelo1. P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients. Transplantation 106(9S):p S719, September 2022. | DOI: 10.1097/01.tp.0000889580.24110.b1
P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients
Sandal, Shaifali1; Yao, Han1; Alam, Ahsan1; D’Arienzo, David1; Baran, Dana1; Cantarovich, Marcelo1. P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients. Transplantation 106(9S):p S719, September 2022. | DOI: 10.1097/01.tp.0000889580.24110.b1
Sandal, Shaifali1; Yao, Han1; Alam, Ahsan1; D’Arienzo, David1; Baran, Dana1; Cantarovich, Marcelo1. P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients. Transplantation 106(9S):p S719,
Sandal, Shaifali1; Yao, Han1; Alam, Ahsan1; D’Arienzo, David1; Baran, Dana1; Cantarovich, Marcelo1. P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients. Transplantation 106(9S):p S719, September 2022. | DOI: 10.1097/01.tp.0000889580.24110.b1
P15.03: Granulocyte Colony-Stimulating Factor With or Without Immunosuppression Reduction in Neutropenic Kidney Transplant Recipients et al, September 2022. | DOI: 10.1097/01.tp.0000889580.24110.b1
Grosso, Dolores et al. A Prospective, Randomized Trial Examining the Use of G-CSF Versus No G-CSF in Patients Post-Autologous Transplantation. Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy, Volume 28, Issue 12, 831.e1 – 831.e7
Raquel Sanabrias Fernández de Sevilla et al, Impact of Neutropenia on Clinical Outcomes after Lung Transplantation , Med. Sci. 2024, 12(4), 56; https://doi.org/10.3390/medsci12040056