TevaGrastim (filgrastim biosimilar) / Nippon Kayaku, Teva - LARVOL DELTA

Chronic Graft-Versus-Host Disease Following Intestine, Liver, Pancreas, and Stomach Transplantation (ACG 2026) - "Therapy escalates from everolimus and octreotide to capecitabine and temozolomide, with subsequent disease progression...Dermatology and hematology are consulted, topical steroids are started for the rash and tbo-filgrastim for worsening neutropenia...After refusing cytogam, he returns with rising CMV levels, is treated with IV ganciclovir, and discharged with oral valganciclovir...Persistent donor predominance on STR analysis with cutaneous and bone marrow involvement is shown. Treatment includes corticosteroids, etanercept, photopheresis, ruxolitinib, and supportive care."

Acute Graft versus Host Disease • Cardiovascular • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Gastrointestinal Neuroendocrine Tumor • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Leukopenia • Neuroendocrine Tumor • Neutropenia • Pulmonary Disease • Respiratory Diseases • Solid Organ Transplantation • Solid Tumor • Transplantation

ADVERSE EVENTS WITH G-CSF FOR NEUTROPENIA IN CANCER. (ASCO 2018) - "The first administration of filgrastim (FIL), tbo-filgrastim (TBO), or filgrastim-sdnz (SNDZ) served as the index date. Differences observed in demographic and clinical characteristics of the populations receiving the rG-CSFs may be due to the differences in labeled indications such as cancer type or age, reimbursement policies, or provider preferences. Safety profiles were similar with only slight differences in AE rates potentially due to underlying differences in baseline characteristics of the populations."

Adverse events • Leukemia • Lymphoma

Poly-Infections in a Patient Living With Human Immunodeficiency Virus (HIV). (PubMed, Cureus) - "Bone marrow examination combined with genetic and molecular testing revealed a diagnosis of T-cell large granular lymphocytic leukemia (T-LGL), which explained the lack of response to tbo-filgrastim...Undiagnosed T-LGL may present with gram-negative bacteremia and failure to respond to granulocyte colony-stimulating factor (G-CSF), and Strongyloides infection should be considered in immunocompromised patients who are being evaluated for occult malignancy, even without identifiable epidemiological risk factors. Early recognition of these conditions can guide timely evaluation and appropriate therapy in complex immunocompromised hosts."

Journal • Febrile Neutropenia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Neutropenia • Oncology • T-Cell Large Granular Lymphocyte Leukemia • CD4

Evaluation of Inpatient Use of Tbo-Filgrastim (ASHP 2025) - No abstract available

Clinical

THE DOUBLE-EDGED SWORD OF NEUTROPHIL RECOVERY: A CASE REPORT OF G-CSF-INDUCED ARDS IN CHEMOTHERAPY-INDUCED FEBRILE NEUTROPENIA (CHEST 2025) - "She was given Cefepime and started on tbo-filgrastim (Granix) 300 mcg/day for neutropenia...Tbofilgrastim was discontinued, vancomycin was added to cefepime, and corticosteroids were initiated... G-CSF–induced ARDS is a rare but potentially fatal complication that underscores the complexity of neutrophil recovery in critically ill patients with chemotherapy-induced neutropenia."

Case report • Clinical • Acute Respiratory Distress Syndrome • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Respiratory Diseases • Solid Tumor • CXCL8 • IL1B • TNFA

A case of refractory methimazole-induced agranulocytosis treated with high-dose G-CSF (ENDO 2024) - "Her hyperthyroidism was managed with propranolol and iodine solution in anticipation of definitive thyroidectomy. On day 4 of admission, tbo-filgrastim 450 mcg daily injections were started for persistent neutropenia...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • Agranulocytosis • Endocrine Disorders • Febrile Neutropenia • Granulocytopenia • Grave’s Disease • Hematological Disorders • Infectious Disease • Neutropenia

Hermansky-Pudlak syndrome: anesthetic management of a rare disease (Euroanaesthesia 2024) - "Epinephrine and ADP thrombocyte function test have been performed, both test results were higher than normal values. After premedication, anesthesia was induced with propofol and fentanyl, and maintained with propofol and remifentanil iv infusions...Tranexamic acid infusion 20mg/h and noradrenaline infusion 0,3mcg/kg/h were started...We didn’t have ventilation difficulties in our case however we had abundant bleeding and needed massive transfusion. Platelet replacement is considered the most important approach while use of desmopressin and tranexamic acid is still controversial."

Anesthesia • Cardiovascular • Critical care • Fibrosis • Hematological Disorders • Immunology • Neutropenia • Pediatrics • Pulmonary Disease • Rare Diseases • Respiratory Diseases

Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019. (PubMed, J Manag Care Spec Pharm) - "We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs."

Journal • Medicare • Reimbursement • US reimbursement

Evaluating the Use of Tbo-filgrastim in Lung Transplant Recipients with Neutropenia (ASHP 2023) - No abstract available

Clinical • Hematological Disorders • Neutropenia • Transplantation

IRONMAN IS EMPTY INSIDE: WHEN CHELATION THERAPY GETS GREEDY (CHEST 2023) - "Vasopressors were initiated and the patient was transferred to the intensive care unit.The patient underwent extensive infectious workup and empiric antibiotics administered - cefepime, vancomycin, ampicillin, and micafungin...On review of prior records, patient's thalassemia was complicated by secondary hemochromatosis with extramedullary hematopoietic masses, splenomegaly, on chelation therapy with deferoxamine and recently started on deferiprone one year ago...Chelation therapy was held, and patient was started on tbo-filgrastim with gradual improvement... We highlight a case of chelation-induced neutropenia in a patient with septic shock. It is imperative to understand the risk of agranulocytosis in patients undergoing chelation therapy as well as the unique empiric antibiotic options available. Vigilance for any development of immune reconstitution syndrome as neutropenia improves is key for positive outcomes."

Agranulocytosis • Beta-Thalassemia • Critical care • Febrile Neutropenia • Gastrointestinal Disorder • Genetic Disorders • Granulocytopenia • Hematological Disorders • Hepatology • Hypotension • Infectious Disease • Inflammation • Leukopenia • Neutropenia • Septic Shock • Thrombocytopenia

Provider Barriers in Uptake of Biosimilars: Case Study on Filgrastim (AJMC) - "In this study, we offer a first look at an underappreciated source of disparities in access to lower-cost biologic drugs. Individuals living in rural areas, including a significant proportion of Americans 65 years and older,9 may have fewer choices of hospitals than those living in urban areas, and they typically seek care in hospitals with RRC or RHC designations. Without access to lower-cost biosimilars, they may end up paying more for some high-cost treatments. As more biosimilars enter the market, results of our study reveal opportunities for targeted policies to encourage adoption of lower-cost treatments, particularly among hospitals treating older patients with fewer choices in care site."

Online posting

Mobilization of hematopoietic stem cells with lenograstim in multiple myeloma patients: Prospective multicenter observational study (KMM122). (PubMed, Cancer Med) - "Lenograstim can safely and effectively mobilize stem cells in MM autologous settings."

Journal • Observational data • Bone Marrow Transplantation • Gastrointestinal Disorder • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Pain • Oncology • Pain • Transplantation • CD34

A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma (ASH 2022) - "Of 2,094 (81%) patients who received high-risk chemotherapy, 1,919 (92%) received pegfilgrastim, 71 (3%) pegfilgrastim-cbqv, 49 (2%) pegfilgrastim-jmdb, 21 (<1%) filgrastim, 20 (<1%) filgrastim-sndz, and 14 (<1%) tbo-filgrastim or a combination of products...The most common chemotherapy regimens included cyclophosphamide/doxorubicin/vincristine/rituximab (n=1,304), bendamustine/rituximab (n=469), cyclophosphamide/rituximab (n=119), cyclophosphamide/doxorubicin/vincristine (n=105), rituximab (n=101), doxorubicin/vinblastine (n=91), and cyclophosphamide/doxorubicin/etoposide/vincristine/rituximab (n=46)...Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products."

Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CSF3

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Nov 2022

Trial completion • Trial completion date • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD34

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (clinicaltrials.gov) - P3; N=987; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; Initiation date: Nov 2019 ➔ Jul 2019

Clinical • Enrollment open • Trial initiation date • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Rheumatoid Arthritis

Is split-dose better than single-dose? Results of Turkish Stem Cell Coordination Center (TURKOK) donors in the era of rising biosimilar G-CSF. (PubMed, J Clin Apher) - "Split-dose may be recommended for cases where the need for large numbers of CD34+ cells to be harvested is anticipated due to significant cell yield relative to recipient weight. However, sufficient hematopoietic stem cells can be collected with both posology. Tevagrastim is non-inferiority effective to Neupogen. Side effects during administration are both low-grade and temporary."

Journal • Pain • CD34 • CSF3

MOBILIZATION OF HEMATOPOIETIC STEM CELLS WITH LENOGRASTIM IN MULTIPLE MYELOMA PATIENTS WITH MINIMAL RESIDUAL DISEASE (EBMT 2022) - "Background: Current guideline suggest using filgrastim or tbo-filgrastim for mobilization of hematopoietic progenitor cells in autologous setting... Lenograsim can safely and effectively mobilize stem cells in MM autologous setting."

Clinical • Minimal residual disease • Residual disease • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Pain • Oncology • Pain • Transplantation • CD34

Evaluation of Tbo-filgrastim Use in Liver Transplant Patients with Leukopenia at an Academic Medical Center (ASHP 2021) - No abstract available

Clinical • Hematological Disorders • Hepatology • Leukopenia • Transplantation

[VIRTUAL] AKI: Rare Side Effect of Pemetrexed (KIDNEY WEEK 2021) - "The chemotherapy regimen was changed from pembrolizumab to pemetrexed two days prior...Initial treatment included aggressive fluid hydration, a granulocyte colony stimulating factor (TBO-Filgrastim) and empiric IV antibiotics given the severe neutropenia...Although aggressive fluid administration is imperative, the anti-folate effects of pemetrexed must be reversed with folic acid in order to prevent the patient from going onto dialysis. Prompt recognition of this adverse effect can lead to suitable treatment and recovery of his kidney function."

Adverse events • Acute Kidney Injury • Dental Disorders • Fatigue • Hematological Disorders • Lung Cancer • Mucositis • Nephrology • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pain • Renal Disease • Solid Tumor • Stomatitis • MRI

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2; N=76; Active, not recruiting; Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University; N=140 ➔ 76

Clinical • Enrollment change • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD34

A Study of Tbo-Filgrastim (Granix) to Disrupt the Bone Marrow Microenvironment in Patients with Multiple Myeloma Undergoing Autologous Stem Cell Transplantation (ASH 2018) - P2; "The current standard of care for transplant eligible patients is therapy with high-dose melphalan (HDM) followed by autologous stem cell transplant (ASCT). There was no difference in Day +100 CR or ORR rates, PFS, or OS in patients treated with tbo-filgrastim plus HDM versus HDM alone with a median follow-up of 21.7 months. The lack of efficacy may be secondary to the high pre-ASCT response rates seen with modern agents."

Clinical • Biosimilar • Hematological Disorders • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Transplantation

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2; N=140; Active, not recruiting; Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD34

Site of care potentially limits cost savings from biosimilars. (PubMed, Am J Manag Care) - "Although previous work has found lower costs for biosimilar filgrastim compared with reference filgrastim, here we found that site of care can change this calculus, reducing savings. After adjusting for patient characteristics and geography, we found that drug cost savings for biosimilar filgrastim were limited to the office setting, with no savings in the outpatient hospital setting."

HEOR • Journal • Hematological Disorders • Neutropenia

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P1 trial • Diffuse Large B Cell Lymphoma • Human Immunodeficiency Virus • Infectious Disease • CD20 • CD4

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1; N=54; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Trial completion date: Sep 2020 ➔ Jul 2023; Trial primary completion date: Sep 2020 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4