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Carimune NF Liquid is a Safe and Effective Immunoglobulin Replacement Therapy in Patients with Primary Immunodeficiency Diseases

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Subjects with primary immune deficiency diseases treated with intravenous immunoglobulin (n=42) received intravenous infusions of Carimune NF Liquid every 3–4 weeks for 6 months without routine premedication. The mean dose/patient/infusion was 278.5–800.7 mg/kg. Also, 80.4% of infusions achieved maximum rates of ≥3.5 mg/kg/min; 32% of infusions were associated with adverse events during or within 48 h of their end (upper 95% confidence interval was 39.4%, meeting the Food and Drug Administration (FDA) criterion for acceptable tolerability), and 54.8% of subjects had at least one temporally associated adverse event considered at least possibly drug-related (headache: 35.7% of subjects, 12.4% of infusions; nausea: 14.3%, 3.5%; myalgia: 14.3%, 3.2%; fatigue: 11.9%, 5.7%). The frequencies of these were highest after the first infusion. There were no serious drug-related adverse events or acute serious bacterial infections. Serum IgG trough levels were unchanged from baseline. Carimune NF Liquid, a ready-to-use, high-concentration, liquid immunoglobulin preparation is safe and effective.

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ACKNOWLEDGMENTS

This project was funded in part by grant MOI-RR02172 from the NCCR, NIH to the Children’s Hospital Boston GCRC, and this study was supported by CSL Behring. The authors would like to thank Dr. Jo Oswald and Dr. Catherine Jones, Watermeadow Medical, for their editorial assistance. Dr. Berger has received speaking and/or consultancy fees from CSL Behring, Talecris, INC Research, Grifols, Inc., FFF Enterprises and America’s Health Insurance Plans (contractor for Centers for Disease Control) and has received research funding from Talecris. Dr. Cunningham-Rundles has been a member of Medical Advisory Boards of Talecris and Omrix. Dr. Bonilla has received grant support from Talecris Biotherapeutics and is on the Medical Advisory Committee of the Immune Deficiency Foundation. Dr. Melamed has no relevant conflicts of interest. Dr. Bichler and Dr. Zenker are employees of CSL Behring. Dr. Ballow has been a speaker for and is a member of the Advisory Board of Talecris Biotherapeutics.

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Authors and Affiliations

  1. Rainbow Babies and Children’s Hospital, Division of Allergy/Immunology, 111100 Euclid Avenue, Cleveland, Ohio, 44106, USA

    Melvin Berger

  2. Mount Sinai School of Medicine, 1425 Madison Avenue, Box 1089, New York, New York, 10029, USA

    Charlotte Cunningham-Rundles

  3. Children’s Hospital Boston, 300 Longwood Avenue, Boston, MA, 02115, USA

    Francisco A Bonilla

  4. 1st Allergy & Clinical Research Center, 7343 S. Alton Way, Ste. 100, Centennial, CO, 80112, USA

    Isaac Melamed

  5. CSL Behring AG, Berne, Switzerland

    Johann Bichler & Othmar Zenker

  6. Department of Pediatrics, School of Medicine and Biomedical Sciences, Children’s Hospital of Buffalo, 219 Bryant Street, Buffalo, New York, 14222-2099, USA

    Mark Ballow

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  1. Melvin Berger
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  2. Charlotte Cunningham-Rundles
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  3. Francisco A Bonilla
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  4. Isaac Melamed
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  7. Mark Ballow
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Correspondence to Melvin Berger.

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Berger, M., Cunningham-Rundles, C., Bonilla, F.A. et al. Carimune NF Liquid is a Safe and Effective Immunoglobulin Replacement Therapy in Patients with Primary Immunodeficiency Diseases. J Clin Immunol 27, 503–509 (2007). https://doi.org/10.1007/s10875-007-9096-9

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  • DOI: https://doi.org/10.1007/s10875-007-9096-9

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