Gamunex-C (human immune globulin 10%- caprylate/ chromatography purified) / Kedrion, Bayer, Grifols - LARVOL DELTA

Investigation Into the Viscosity of Commercial IVIG Preparations (ISTH 2025) - "Methods Experiments were performed using: ALYGLO™ (immune globulin intravenous, human-stwk 10% liquid), GC Biopharma; OCTAGAM® 10% [immune globulin intravenous (human) 10% liquid], Octapharma; GAMUNEX®-C [immune globulin injection (human), 10% caprylate/chromatography purified], Grifols Therapeutics LLC; PRIVIGEN® [immune globulin intravenous (human), 10% liquid], CSL Behring LLC, and GAMMAGARD LIQUID® [immune globulin infusion (human) 10%], Takeda Pharmaceuticals...Results The results at 25°C were as follows: ALYGLO: 2.506 cP; OCTAGAM: 3.484 cP; GAMUNEX-C: 2.535 cP; PRIVIGEN: 2.698 cP; GAMMAGARD LIQUID: 2.575 cP. For reference, viscosity of human plasma at 25°C generally ranges from 1.5-1.72 cP. Table or Figure Upload"

Cardiovascular • Nephrology • Renal Disease

Investigation into the Viscosity of Commercial IVIG Preparations (CIS 2025) - "Experiments were performed using ALYGLO® [immune globulin intravenous, human-stwk 10% liquid], GC Biopharma; OCTAGAM® 10% [immune globulin intravenous (human) 10% liquid], Octapharma; GAMUNEX®-C [immune globulin injection (human), 10% caprylate/ chromatography purified], Grifols Therapeutics LLC; PRIVIGEN® [immune globulin intravenous (human), 10% liquid], CSL Behring LLC; and GAMMAGARD LIQUID® [immune globulin infusion (human) 10%], Takeda Pharmaceuticals...The results at 25° C were as follows: ALYGLO: 2.506 cP; OCTAGAM: 3.484 cP; GAMUNEX-C: 2.535 cP; PRIVIGEN: 2.698 cP; and GAMMAGARD LIQUID: 2.575 cP...All products showed consistent, sequential decreases in viscosity as temperatures increased, suggesting that IVIG infusions at room temperature (25°C) may be a safety consideration for the prevention of TEEs. These preliminary results warrant further investigation to identify potential differences in the viscosities of commercially..."

Cardiovascular • Nephrology • Renal Disease

iSTAND: IVIG (Gamunex-C) Treatment Study for POTS Subjects (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: University of Texas Southwestern Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Dec 2023 | Trial primary completion date: Sep 2024 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Immunology

Anti-pig Antibodies in Human Immunoglobulin Preparations (IPITA-IXA-CTRMS 2023) - "To validate this hypothesis, we tested a Gamunex-C preparation against lymphocytes from GTKO and 10GE pigs... Our study demonstrates that IVIg preparations contain significant amounts of anti-pig IgGs and may contribute to xenograft rejection by activation of the complement cascade. Therefore, IVIg treatment of antibody-mediated rejection in xenotransplantation should be avoided. Similar considerations apply to any blood products that contain human plasma."

Antibody-mediated Rejection • Transplant Rejection • Transplantation

iSTAND: IVIG (Gamunex-C) Treatment Study for POTS Subjects (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: University of Texas Southwestern Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Cardiovascular • Immunology

The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes (clinicaltrials.gov) - P2 | N=13 | Terminated | Sponsor: Beth Israel Deaconess Medical Center | Completed ➔ Terminated; Funding withdrawn in the midst of the COVID pandemic

Trial termination • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain

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

INTRAVENOUS IMMUNOGLOBULIN (IVIG) FOR SEVERE OR FULMINANT CLOSTRIDIUM DIFFICILE INFECTION (SCCM 2023) - " This is a retrospective review of critically ill patients who received IVIG (Gamunex-C®) for severe or fulminant CDI at NYU Langone Health...Active anti-CDI therapies prior to IVIG administration included enteral vancomycin (93%), IV metronidazole (80%), rectal vancomycin (27%), fidaxomicin (7%), tigecycline (7%) and cholestyramine (7%)... For severe or fulminant CDI, IVIG pharmacotherapy was associated with a favorable treatment response in 73% of patients, possibly averting the need for care escalation to colectomy or FMT. Various dosing strategies were utilized, limiting assessment of a dose-response relationship. Further data and a comparison to a cohort of critically ill patients who did not receive IVIG is needed to delineate place in therapy."

Chronic Kidney Disease • Infectious Disease • Nephrology • Oncology • Renal Disease • Transplantation

iSTAND: IVIG (Gamunex-C) Treatment Study for POTS Subjects (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: University of Texas Southwestern Medical Center | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Immune Modulation • Immunology

The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: Beth Israel Deaconess Medical Center | Unknown status ➔ Completed | N=20 ➔ 13 | Trial completion date: Sep 2021 ➔ Feb 2022 | Trial primary completion date: Sep 2021 ➔ Feb 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain

IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3 (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Beth Israel Deaconess Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Jun 2021 ➔ Feb 2022 | Trial primary completion date: Jun 2021 ➔ Feb 2022

Trial completion • Trial completion date • Trial primary completion date • Pain

Massive Splenomegaly With Non-Cirrhotic Portal Hypertension (ACG 2022) - "He was receiving immune globulin (Gamunex-C) infusions every 28 days...Awareness of this entity is essential to optimize treatment strategies. Figure: Splenomegaly calculated volume of 2000 cc, engorged splenic vein"

Allergy • Cardiovascular • Fibrosis • Gastroenterology • Hematological Disorders • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Failure • Neutropenia • Pain • Portal Hypertension • Primary Immunodeficiency

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial) (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: University of Washington | N=10 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Monotherapy • Trial withdrawal • Myositis

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3 | N=36 | Completed | Sponsor: Grifols Therapeutics LLC | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

A double-blind, placebo controlled trial of Gamunex-C in Patient with Small Fiber Neuropathy Associated with Autoantibodies to TS-HDS and FGFR3 (AAN 2022) - "This small double blind placebo controlled trial showed no difference between IVIG and placebo in any measurable outcome and does not support the use of IVIG for SFN associated with autoantibodies to TS-HDS and/or FGFR3."

Clinical • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • FGFR3

ADVANCE-CIDP 1: A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=138 | Completed | Sponsor: Baxalta now part of Shire | Active, not recruiting ➔ Completed

Trial completion • Pain

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3 | N=36 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Primary Immunodeficiency

iSTAND: IVIG (Gamunex-C) Treatment Study for POTS Subjects (clinicaltrials.gov) - P1/2; N=32; Enrolling by invitation; Sponsor: University of Texas Southwestern Medical Center; Trial completion date: Mar 2022 ➔ Dec 2023; Trial primary completion date: Oct 2021 ➔ Sep 2023

Trial completion date • Trial primary completion date • Cardiovascular • Immune Modulation • Immunology

Pharmacokinetic modeling and simulation of subcutaneous and intravenous IgG dosing in patients with primary immunodeficiency diseases. (PubMed, Int Immunopharmacol) - "A population pharmacokinetic (PK) model for comparing the PK of subcutaneously administered immunoglobulin G (IgG) replacement therapy (SCIG) with Gamunex-C 10% or SCIG 20% formulations in patients with primary immunodeficiency diseases was developed using data from 3 clinical trials (N = 95, 69.5% adults, 30.5% <18 years) of intravenous IG (IVIG) 10% and SCIG 10% or SCIG 20%...Switching from IVIG 10% every 4 weeks to biweekly SCIG 20% produced similar serum IgG exposure, with lower peak and higher trough serum IgG concentrations. Switching from IVIG 10% every 3 or 4 weeks to weekly and biweekly SCIG 20% yielded comparable IgG exposure and clinically effective trough IgG concentrations."

Clinical • Journal • PK/PD data • Immunology • Primary Immunodeficiency

Premedication with Hydrocortisone Increases Risk of Adverse Drug Events and Return to Medical Care Among Pediatric Patients with ITP Treated with IVIG (ASH 2021) - "In order to identify rates of IVIG-associated ADEs and subsequent emergent medical evaluations in pediatric patients with ITP, we completed an retrospective observational cohort study of all pediatric patients with ITP who were treated with one-time IVIG infusion utilizing Gamunex-C ® 10% at a dose of 1g/kg across 4 large pediatric centers from 2010 to 2019...No associations were identified between ADE s and gender, race/ethnicity, premedication with diphenhydramine or ondansetron, pre-treatment serum IgG levels, or concurrent glucocorticoid administration...Patients who received premedication with acetaminophen were less likely to develop IVIG-associated ADEs, but those who received premedication with diphenhydramine or concurrent glucocorticoid therapy were no more or less likely to develop ADEs...Patients returning for emergent medical evaluation frequently underwent repeat laboratory studies or CT imaging, resulting in unnecessary radiation exposure and..."

Adverse events • Clinical • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Immunology • Pain • Pediatrics • Thrombocytopenia • Thrombocytopenic Purpura

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P2; N=100; Completed; Sponsor: Grifols Therapeutics LLC; Active, not recruiting ➔ Completed

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

ADVANCE-CIDP 1: A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3; N=138; Active, not recruiting; Sponsor: Baxalta now part of Shire; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Pain

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency (clinicaltrials.gov) - P3; N=35; Recruiting; Sponsor: Grifols Therapeutics LLC; N=25 ➔ 35

Clinical • Enrollment change • Immunology • Primary Immunodeficiency

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Grifols Therapeutics LLC; Recruiting ➔ Active, not recruiting

Enrollment closed • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • PCR

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Baxalta now part of Shire; N=232 ➔ 120

Enrollment change • Pain