Cytogam (cytomegalovirus immune globulin intravenous(human)) / Kamada - LARVOL DELTA

CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients (clinicaltrials.gov) - P4 | N=45 | Not yet recruiting | Sponsor: Fernanda P Silveira, MD, MS

New P4 trial • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

The Diverse Manifestations of Cytomegalovirus in an Orthotopic Heart Transplant Recipient - A Case Report (ATS 2025) - "The patient was eventually extubated and his respiratory status slowly improved with the use of high-dose steroids, Cytogam, and Ganciclovir...He was sent home with Valcyte, a rapid prednisone taper, valganciclovir, supplemental oxygen and weekly CMV testing as an outpatient. This case highlights the high risk of CMVI in heart transplant patients, despite antiviral prophylaxis. Close monitoring and individualized prophylactic strategies are crucial, as preventing CMVI can reduce readmissions, allograft rejection, and long-term mortality, especially in high-risk, immunosuppressed patients."

Case report • Clinical • Cardiomyopathy • Cardiovascular • Cytomegalovirus Infection • Diabetes • Dyslipidemia • Hypertension • Inflammation • Metabolic Disorders • Pain • Pneumonia • Respiratory Diseases • Transplant Rejection • Transplantation • Type 2 Diabetes Mellitus

Comparative Functional Properties of CMV Immune Globulin vs Polyvalent IGIV Against CMV and Other Viruses (ISHLT 2025) - "Purpose Cytogam (CMVIG), a CMV hyperimmune globulin, is a type of immune globulin intravenous (IGIV) with properties of polyvalent, non-specific IGIV and guaranteed high titer of anti-CMV antibody (CMV titer)...CMV neutralization testing was also higher with CMVIG vs. IGIV. Antibody titers for RSV, Adenovirus, Parainfluenza, and Influenza A were similar in CMVIG and IGIV (Figure 2); notably, qualitative EBV antibody titers were higher in CMVIG.Conclusion CMVIG shows consistently higher CMV antibody titers and neutralization ability compared to polyvalent IGIV, along with similar titers to EBV, RSV, adenovirus, parainfluenza, and influenza A. Clinician awareness of the functional properties of CMVIG and IGIV may be useful for clinical decision making."

Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Collapsing FSGS in a Kidney Transplant Recipient on Sirolimus who Recently Treated for Resistant CMV Viremia (NKF-SCM 2025) - "She developed severe resistant CMV viremia despite Valganciclovir prophylaxis, needing Foscarnet followed by Maribavir for >6 months. In this setting, the immunosuppression was changed from tacrolimus to sirolimus, and she was started on Cytogam every 2 weeks...The pathophysiology of this phenomenon is not completely understood. Nephrologists need to be vigilant and monitor renal function and proteinuria closely when using mTORi."

Clinical • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Hepatology • Nephrology • Renal Disease • Transplantation

Kamada Reports Record Top and Bottom Line 2024 Financial Results and Affirms 2025 Guidance Representing Double-Digit Profitable Growth (GlobeNewswire) - "Total revenues for 2024 were $161.0 million, a 13% increase from the $142.5 million generated in 2023. The increase in revenues was primarily attributable to KEDRAB and CYTOGAM growth year-over-year...Obtained positive feedback from the U.S. FDA, confirming the Agency's agreement with the Company's previously proposed relaxed two-sided Type 1 error rate control of 10% (p-value of 0.1) for the inhaled AAT pivotal Phase 3 study, reducing the study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial. Announced its plan to conduct an interim futility analysis for the inhaled AAT pivotal Phase 3 study by the end of 2025."

Commercial • FDA event • P3 data • Alpha-1 Antitrypsin Deficiency • Cytomegalovirus Infection • Infectious Disease

The Unfortunate Trifecta: Tuberculosis, EBV, and CMV Induced Hemophagocytic Lymphohistiocytosis (ATS 2024) - "Case report: A 52-year-old male with history of end-stage renal disease underwent deceased donor kidney transplant two years prior to presentation and was maintained on mycophenolate, tacrolimus, and prednisone...Broad infectious workup resulted in CMV and EBV viremia, treated with intravenous valganciclovir and cytogam...High clinical suspicion for HLH (H-score 218, 93-96% probability) prompted therapy with dexamethasone and anakinra (IL-1 blocker) following biopsy...Globally, cases of MTB induced HLH have a 54% survival rate, with diagnostic delay resulting in delay of appropriate antimicrobials and worse outcomes. These diagnostic delays warrant consideration of empiric MTB therapy for immunocompromised patients under suspicion for HLH."

Acute Kidney Injury • Acute Respiratory Distress Syndrome • Cardiovascular • CNS Disorders • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Hypotension • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Septic Shock • Transplantation • Tuberculosis • IL2RA

A Case of Idiopathic Pneumonia Syndrome in a Patient With Recent Stem Cell Transplant (ATS 2024) - "No eosinophils were seen on BAL given the recent Daptomycin thus excluding acute eosinophilic pneumonia. CMV DNA quant was elevated at 1002 so the patient was transitioned to Ganciclovir and given Cytogam...Treatment for IPS involves a combination of approaches, including oxygen therapy, ventilatory support if needed, systemic corticosteroids, and immunosuppressive medications such as Etanercept which block tumor necrosis factor. Early recognition and intervention are crucial for achieving favorable outcomes in these challenging cases. This also highlights the importance of treating possible infectious etiologies while awaiting workup and when unable to rule out certain infections."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • Transplantation • TNFA

Adjunctive Cytogam and CMV Insight T-Cell Immunity Assay for Refractory CMV Disease in Heart Transplant Recipients - Single-Center Case Series of Challenging Cases (ISHLT 2024) - "He was receiving tacrolimus and prednisone 5 mg...He was treated with foscarnet induction and Cytogam 150 mg/kg per week for 6 weeks, with 2 months of oral maribavir, and transitioned to secondary prophylaxis with letermovir...It was resistant to ganciclovir and foscarnet induction followed by maribavir. She was admitted to receive IV cidofovir and CytoGam 100mg/kg every week for 6 weeks and is thriving after completing long-term treatment with letermovir with CMV viral load at less than 137 [IU/mL]...CytoGam therapy was associated with decreased circulating viral loads and was well-tolerated. Further study of approaches including traditional antiviral agents, passive humoral immunotherapy (such as CytoGam) is needed."

Clinical • IO biomarker • Cytomegalovirus Infection • Gastrointestinal Disorder • Infectious Disease • Septic Shock • Transplantation

Elevated Cell-free DNA After Heart Transplantation - It Ain’t Always Rejection: A Case Study Of CMV Infection (HFSA 2023) - "Her symptoms improved with treatment of ganciclovir and cytogam. (Figure 1)Summary: Dd-cfDNA may be elevated in the presence of CMV infection. Further studies are needed to validate these preliminary findings."

Cell-free DNA • Clinical • Antibody-mediated Rejection • Cardiovascular • Cytomegalovirus Infection • Immunology • Infectious Disease • Inflammation • Pneumonia • Transplant Rejection • Transplantation

MULTIORGAN FAILURE DUE TO CMV-INDUCED HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (CHEST 2023) - "CASE PRESENTATION: A 59-year-old male with relapsed peripheral T cell lymphoma treated with multiple lines of chemotherapy most recently ruxolitinib as bridge to CAR-T cell therapy/stem cell transplant...CMV pneumonitis was entertained, and he was treated with ganciclovir and Cytogam... Our case report highlights the importance of a high index of suspicion of HLH in patients presenting with CMV pneumonitis and the need for early and rapid diagnostic workup, and treatment."

Acute Kidney Injury • Atrial Fibrillation • Bone Marrow Transplantation • Cardiovascular • Cytomegalovirus Infection • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Metabolic Disorders • Nephrology • Oncology • Peripheral T-cell Lymphoma • Pneumonia • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Septic Shock • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • Transplantation • IL2

Incidence and Outcomes of CMV Infection in Pancreas Transplant with Thymoglobulin Induction: A Single Center Experience (ATC 2022) - "PTRs were on tacrolimus, mycophenolate +/- steroids for maintenance immunosuppression (IS) and one on azathioprine instead of mycophenolate...Foscarnet and/ or cytogam were used in 2/9 patients based on their response to standard treatment... Our study suggests higher CMV incidence in the first year post-transplant and in the SPK group. CMV viremia in PTR did not affect patient or graft survival, however, higher rates of PTD were noted in the viremic group. In our experience, most patients can be successfully treated with decreased immunosuppression and PO valganciclovir or IV ganciclovir."

Clinical • Cytomegalovirus Infection • Diabetes • Hepatology • Infectious Disease • Metabolic Disorders • Transplant Rejection • Transplantation

Effectiveness of Prophylactic Human Cytomegalovirus Hyperimmunoglobulin in Preventing Cytomegalovirus Infection following Transplantation: A Systematic Review and Meta-Analysis. (PubMed, Life (Basel)) - "Similar results were observed in analyses limited to publications evaluating currently available CMVIG products (Cytotect CP and Cytogam; p < 0.001). In combination with the established safety profile for CMVIG, these results suggest that prophylactic CMVIG treatment in patients undergoing solid organ transplantation may be beneficial, particularly in those at high risk of CMV infection or disease."

Journal • Retrospective data • Review • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Solid Organ Transplantation • Transplantation

Kamada Announces Strategic Transformational Transaction Positioning the Company as a Global Leader in the Plasma-Derived Hyperimmune Market Through the Acquisition of a Portfolio of Four FDA-Approved Commercial Products (GlobeNewswire) - "Kamada...today announced that it has acquired a portfolio of four U.S. Food and Drug Administration (FDA)-approved plasma-derived hyperimmune commercial products from Saol Therapeutics ('Saol')...CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) product indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and heart....The tech transfer process for Cytogam is already well underway, and Kamada expects to receive FDA approval for manufacturing of the product and initiate commercial manufacturing of the product at its facility in Israel, by the end of 2022."

Commercial • Cytomegalovirus Infection • Hepatitis B • Infectious Disease