Privigen (human immune globulin intravenous 10%) / CSL Behring - LARVOL DELTA

Unmasking the ABO Antibody Ingredient List in IVIg Preparations (WTC 2025) - "We used a LuminexTM single-antigen bead assay to measure ABO-Ab to A and B subtypes glycans to detect the ABO-Ab in commercially available IVIg products.* Thirteen IVIg lot numbers from six IVIg preparations (Privigen, Cuvirtru, Cutaquig, Hizentra, Octagram, and Gammagard Liquid) were evaluated using LuminexTM beads coupled to individual subtype ABO-A and -B glycans (subtypes I through VI)... It is valuable to know the level of ABO-Ab in IVIg for many reasons. In many clinical scenarios beyond transplantation, these ABO-Ab may cause IVIg-related red cell hemolysis. In the setting of ABO-incompatible transplantation, the presence of passively acquired ABO-Ab may interfere with the measurement of patient ABO-Ab levels pre- and post-transplant."

Hematological Disorders

IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: The University of Hong Kong | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date

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

IVIG Administration: Lessons from Cross-Institutional Protocol Review. (PubMed, Hosp Pharm) - "The most common formulation of IVIG used was Privigen®, followed by Gammagard®...Significant variation in medication selection and standardization was identified in pre-medication practices and management of adverse reactions. This study highlights the variability in IVIG administration protocols and underscores the need for standardized practices to enhance patient safety and treatment efficacy."

Journal • Immunology • Renal Disease

Empirical Time-Series Analysis (1991–2023) of Immune Thrombocytopenia Medications in U.S. Medicaid Programs (ISPOR 2025) - "Comparative market-share analyses were conducted across therapeutic classes to identify key drivers of market changes, including policy shifts, competition, and new drug entries The utilization trends revealed Rituxan dominated until 2020, after biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen. Among TPO-RAs, Promacta surpassed Nplate in 2018, reflecting a shift in prescribing patterns. Pricing data highlighted Promacta as the most expensive TPO-RA, Panzyga led IVIG pricing by 2019... This analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors like the introduction of biosimilars, competitive market dynamics, and clinical advancements. These findings provide valuable insights for healthcare policymakers, payers, and clinicians to..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

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

A Phase 2 randomised trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis. (PubMed, Rheumatology (Oxford)) - P2 | "This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications."

Journal • P2 data • PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

IVIG Vs SCIG in CIDP (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Rutgers, The State University of New Jersey | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Pain

Open-label Trial of IVIG in Children With PANS (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Göteborg University | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Pediatrics • Psychiatry

Indirect Treatment Comparison of Efgartigimod vs Immunoglobulins in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ISPOR-EU 2024) - "Among the studies that met the predefined criteria, an ITC was considered feasible against Privigen, Hizentra, and HyQvia. Despite the limitations of the analysis and the limited comparability of the studies, the ITC results indicate that efgartigimod has a comparable or better efficacy profile than EMA-approved immunoglobulins. Further prospective comparative studies are needed to confirm these results."

Pain

AN UNUSUAL REACTION TO HIZENTRA (SUBCUTANEOUS IMMUNE GLOBULIN (HUMAN) 20% LIQUID) (ACAAI 2024) - "Case Description: A 71-year-old female with Myasthenia Gravis on weekly 60 mg infusions of Immune Globulin Subcutaneous (Human) 20% Liquid started 2 years prior, Parkinson's Disease on Carbidopa/ Levodopa, and history of remote stress-induced urticaria, presented with 6 months of recurring, pruritic, erythematous urticarial rash on her arms and torso appearing within hours of infusions. Hizentra is a 20% solution that contains L-proline and polysorbate 80 whereas Privigen is a 10% solution with L-proline, and both have very low IgA content, <50 mcg/mL and <25 mcg/mL respectively. Urticarial Reaction to Subcutaneous Immune Globulin These recurring, pruritic, erythematous urticarial lesions were present on the arms and torso within hours of subcutaneous immune globulin infusion."

CNS Disorders • Dermatology • Immunology • Infectious Disease • Movement Disorders • Myasthenia Gravis • Novel Coronavirus Disease • Parkinson's Disease • Respiratory Diseases • Urticaria

SYMMETRICAL DRUG-RELATED INTERTRIGINOUS AND FLEXURAL EXANTHEMA (SDRIFE) FOLLOWING FIRST ADMINISTRATION OF IMMUNOGLOBULIN REPLACEMENT (ACAAI 2024) - "Case Description: A 34-year-old female with history of multiple sclerosis on rituximab therapy was initially evaluated for hypogammaglobulinemia with recurrent upper respiratory infections. Workup revealed decreased immunoglobulin G (IgG) of 466 mg/dl, absent titers to streptococcus pneumoniae and haemophilus influenza without improvement following Pneumovax challenge...Emergency room evaluation with Dermatology evaluation revealed normal blood counts and chemistries with elevated C-reactive protein suggestive of a diagnosis of SDRIFE that was treated with a prednisone taper...This case describes the second reported SDRIFE resulting from IVIG and is the first to describe successful avoidance of exanthem on subsequent exposures. With the change to Gamunex from Privigen formulation, the patient has tolerated the recommended treatment without further complications and remains infection free."

CNS Disorders • Dermatology • Infectious Disease • Influenza • Multiple Sclerosis • Pneumococcal Infections • Pneumonia • Respiratory Diseases • CRP

rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT) (clinicaltrials.gov) - P3 | N=17 | Completed | Sponsor: Institute for Clinical and Experimental Medicine | Recruiting ➔ Completed | N=138 ➔ 17

Enrollment change • Trial completion • Transplantation

Association between serum IgG concentrations and the incidence of infections in patients with chronic lymphocytic leukemia and secondary immunodeficiency under treatment with Privigen. (PubMed, Int J Clin Pharmacol Ther) - "This analysis confirms the association of serum IgG trough levels with the incidence of infections and highlights the importance of careful monitoring of IgG levels during treatment of secondary immunodeficiencies in CLL patients."

Journal • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology

IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: The University of Hong Kong | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Combination therapy • Trial completion date • Trial primary completion date

rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT) (clinicaltrials.gov) - P3 | N=138 | Recruiting | Sponsor: Institute for Clinical and Experimental Medicine | Trial primary completion date: Apr 2022 ➔ Apr 2024

Trial primary completion date • Transplantation

IgNiTE: Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis (clinicaltrials.gov) - P3 | N=18 | Completed | Sponsor: University of Oxford | Unknown status ➔ Completed | N=308 ➔ 18

Enrollment change • Trial completion • CNS Disorders

IVIG in Painful Sensory Neuropathy (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Sorlandet Hospital HF

New P4 trial • Pain

Effectiveness of two same-manufacturer intravenous immunoglobulin for Kawasaki disease. (PubMed, J Formos Med Assoc) - "Compared with brand T, brand P prolonged the fever and hospitalization durations after IVIG treatment and increased the proportion of IVIG treatment unresponsiveness, but it did not infer the coronary arteries sequelae."

Journal • Vasculitis

Comparative effectiveness of two intravenous immunoglobulin products in children with Kawasaki disease, a nationwide cohort study. (PubMed, Sci Rep) - "This study aims to conduct a head to head comparison of two IVIGs, TBSF and Privigen, from a nationwide perspective...The secondary endpoints encompassed two distinct criteria: coronary involvement, which was defined as the prolonged use of aspirin or anti-coagulation agents between 180 and 360 days after the index date, and recurrence, which was defined as readmission for IVIG therapy occurring more than 30 days after previous KD index day and continuing until the end of the follow-up period...The discrepancy may be due to the concentration, the stabilizers, or the source of plasma. Further investigation is needed to compare the effectiveness of different IVIGs in the large randomized controlled clinical trial."

Clinical • HEOR • Journal • Cardiovascular • Heart Failure • Pediatrics

Overall safety and effectiveness of the IVIG Privigen® in immunodeficiencies before and after the implementation of an immunoaffinity chromatography isoagglutinin reduction step in the manufacturing process – Results from an observational study (DGHO 2023) - "The implementation of an immunoaffinity chromatography step in the manufacturing process had no discernible negative impact on the overall safety of Privigen ® and its effectiveness in immunodeficiencies."

Clinical • Observational data • Anemia • Hematological Disorders • Immunology • Infectious Disease

IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: The University of Hong Kong | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed

Two Dose Levels of Privigen in Pediatric CIDP (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: CSL Behring | Trial completion date: Jan 2027 ➔ Dec 2029 | Trial primary completion date: Jan 2027 ➔ Dec 2029

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

Passive transfer of hepatitis B core antibody after intravenous immunoglobulin administration in adult patients: a retrospective review (EASL-ILC 2023) - "Because of uncertainly and poor knowledge around baseline testing, all received antiviral treatment consisting of either tenofovir (10%), entecavir (13%) or lamivudine (77%), prior to being initiated on immunosuppressive therapy...The most common HNIg used was Privigen/Hizentra with 30 patients (38%) for both seronegative and seropositive patients. Many patients changed to subcutaneous immunoglobulin (SCIg) administration of HNIg during the Covid-19 pandemic, which included Hizentra and Cuvitru... Passive transfer of hepatitis B core antibody is common after HNIg infusions. Hepatitis B core antibody screening should be considered standard practice for each human normal immunoglobulin administration, effectively improving therapeutic decisions by preventing wrong diagnosis of hepatitis B exposure and therefore preventing unnecessary anti-viral use."

Retrospective data • Review • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease

Rapid desensitization to intravenous immunoglobulins (EAACI 2023) - "The desensitization procedure consisted of a 3-solution 12-step protocol with Plangamma®, Flebogamma® or Privigen®, administered at fixed intervals every 15 minutes until the target dose was reached.ResultsThe initial adverse reactions reported were cutaneous symptoms (urticaria and erythema) in all patients, and hypotension in 1 patient...Undiluted IDTs yielded a positive result with Plangamma® (50mg/ml) in 1, and Flebogamma® (50mg/ml) in 1 out of 4 patients...All desensitizations were tolerated and a total of 48 rapid desensitizations were successfully administered. ConclusionA rapid desensitization procedure to IVIG has shown to be safe and effective in patients with a hypersensitivity reaction to immunoglobulins."

Allergy • Immunology