Flebogamma 10% DIF (human immune globulin intravenous 10%) / Grifols - LARVOL DELTA

Tolerability of immunoglobulin products and outcomes after product switching: a single-center real-world retrospective study. (PubMed, Front Immunol) - "Among the seven patients treated with facilitated SCIG (SC HyQvia®), three experienced ADRs, and one of them was switched back to conventional SCIG (SC Hizentra®) due to persistent local adverse reactions, with no further ADRs reported after the switch. ADRs associated with IVIG are common and lead to treatment switching in a high proportion of patients. Switching to an alternative immunoglobulin product appears to be a good alternative for managing ADRs."

Journal • Observational data • Real-world evidence • Retrospective data

REAL-WORLD EFFECTIVENESS AND SAFETY OF A PREPARATION OF INTRAVENOUS IMMUNOGLOBULIN FOR IMMUNE THROMBOCYTOPENIA (EHA 2026) - "One non-serious skin rash and two thromboses were reported: one ischemic stroke and one cerebral venous thrombosis 5 and 28 days after exposure, respectively; both patients had other risk factors for thrombosis (notably, concomitant exposure to thrombopoietin receptor agonists). Summary/Conclusion Flebogamma DIF ® was effective in real-world clinical practice with a high response rate and was well tolerated."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Cardiovascular • Hematological Disorders • Immune Thrombocytopenic Purpura • Ischemic stroke • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

A Comparative Analysis of the Efficacy, Safety and Mechanism of Action of Flebogamma DIF, Fostamatinib and Romiplostim in Immune Thrombocytopenia. (PubMed, Life (Basel)) - "Overall, these therapies offer distinct advantages depending on disease chronicity, patient age, comorbidities, and treatment history. This review underscores the importance of personalized treatment strategies and highlights the need for further long-term, comparative studies to guide evidence-based ITP management."

Clinical • Journal • Review • Cardiovascular • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Pediatrics • Thrombocytopenia • Thrombocytopenic Purpura • Thrombosis

Incidence of BK Virus Replication in Patients Undergoing HLA and ABO Desensitization (WTC 2025) - "The desensitization protocol was similar for both: Rituximab 375 mg/m² one month before transplantation, except in HLA DD, where it was administered at the end of apheresis and immunoglobulin sessions... The incidence of BK virus replication in high immunological risk patients is higher in ABOi compared to HLAi (LD). It is lower than in HLAi (DD) patients, although the latter group universally receives thymoglobulin. In desensitization protocols with living donors, a significant difference was observed in patients who received CMV-specific immunoglobulin, although its role remains to be defined."

Clinical • Infectious Disease • Renal Disease

Safety and tolerability of pooled human immune globulins after topical ophthalmic administration in New Zealand White rabbits. (PubMed, Cutan Ocul Toxicol) - "Administration of immune globulins had no effect on intraocular pressure. Flebogamma® 5% DIF and Flebogamma® 10% DIF were well-tolerated by NZW rabbits following single and repeat dose topical ophthalmic administration, supporting the future development of topical pooled human immune globulins for the treatment of ocular surface disease."

Journal • Preclinical • Dry Eye Disease • Ophthalmology

Surveillance of anti-SARS-CoV-2 antibodies in plasma pools and in immunoglobulin medicinal products manufactured since 2020 has shown high neutralizing activity against SARS-CoV-2 and current variants (CIS 2023) - "Methods Healthy donors plasma pools collected in the US and Europe, and the subsequent intravenous (Flebogamma DIFand Gamunex-C, Grifols) and subcutaneous (Xembify, Grifols) IgG manufactured batches were followed from March 2020...Intravenous and subcutaneous IgG products efficiently neutralized the current circulating VOC, Omicron BA.5. Further research is warranted to assess whether a clinical protective titer against SARS-CoV-2 and passive immunization is achieved in patients with immunodeficiencies treated with IgG products."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P2; N=100; Completed; Sponsor: Instituto Grifols, S.A.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • PCR

Anti-SARS-CoV-2 Antibodies Within IVIg Preparations: Cross-Reactivities With Seasonal Coronaviruses, Natural Autoimmunity, and Therapeutic Implications. (PubMed, Front Immunol) - " 13 samples from 5 commercial IVIg preparations from pre-pandemic donors (HyQvia (Baxalta Innovations GmbH); Privigen (CSL Behring); Intratect (Biotest AG); IgVena (Kedrion S.p.A); and Flebogamma (Grifols S.A.) were blindly screened using a semi-quantitative FDA-approved and validated enzyme-linked immunosorbent assay (ELISA) (Euroimmun, Lubeck, Germany)... Pre-pandemic IVIg donors have either natural autoantibodies or pre-pandemic cross-reactive antibodies against antigenic protein fragments conserved among the "common cold" - related coronaviruses. The findings are important in: (a) assessing true anti-SARS-CoV-2-IgG seroprevalence avoiding false positivity in IVIg-receiving patients; (b) exploring potential protective benefits in patients with immune-mediated conditions and immunodeficiencies receiving acute or chronic maintenance IVIg therapy, and (c) validating data from a recent controlled study that showed significantly lower in-hospital mortality in the..."

Journal • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Instituto Grifols, S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and safety study of IVIG in hospitalized subjects with COVID-19 Estudio de eficacia y seguridad de IGIV en sujetos hospitalizados con COVID-19 (clinicaltrialsregister.eu) - P2; N=100; Ongoing; Sponsor: Instituto Grifols, S.A

Clinical • New P2 trial

Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation Recambio plasmático en pacientes con enfermedad COVID-19 y ventilación mecánica invasiva (clinicaltrialsregister.eu) - P2; N=116; Ongoing; Sponsor: Fundació Clínic per a la recerca Biomèdica

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and efficacy of intravenous immunoglobulin (Flebogamma 10% DIF) in patients with immune thrombocytopenic purpura. (PubMed, Immunotherapy) - "Flebogamma 10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP."

Clinical • Journal