Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex™, 10%)
Corresponding Author
M. Ballow
Children's Hospital of Buffalo SUNY/Buffalo, Buffalo, New York, USA
Mark Ballow, MD, Professor of Pediatrics, Chief, Division of Allergy/Immunology and Pediatric Rheumatology, Kaleida Health at The Children's Hospital of Buffalo, Department of Pediatrics, 219 Bryant Street, Buffalo, NY 14222, USA E-mail: [email protected]Search for more papers by this authorM. Berger
Rainbow Babies and Children's Hospital, Case Western Reserve, Cleveland, Ohio, USA
Search for more papers by this authorR. H. Buckley
Duke University Medical Center, Department of Pediatrics, Durham, North Carolina, USA
Search for more papers by this authorC. H. Cunningham-Rundles
Mount Sinai Medical Center, New York, New York, USA
Search for more papers by this authorP. Fireman
Children's Hospital of Pittsburgh, Section of Allergy & Immunology, Pittsburgh, Pennsylvania, USA
Search for more papers by this authorM. Kaliner
Institute for Asthma & Allergy, Chevy Chase and Wheaton, Maryland, USA
Search for more papers by this authorH. D. Ochs
University of Washington School of Medicine, Health Science Building, Seattle, Washington, USA
Search for more papers by this authorS. Skoda-Smith
University of Florida, Shands Hospital, Gainesville, Florida, USA
Search for more papers by this authorM. T. Sweetser
University of Washington School of Medicine, Health Science Building, Seattle, Washington, USA
Search for more papers by this authorC. Lathia
Bayer Pharmaceuticals Corporation, West Haven, Connecticut, USA
Search for more papers by this authorCorresponding Author
M. Ballow
Children's Hospital of Buffalo SUNY/Buffalo, Buffalo, New York, USA
Mark Ballow, MD, Professor of Pediatrics, Chief, Division of Allergy/Immunology and Pediatric Rheumatology, Kaleida Health at The Children's Hospital of Buffalo, Department of Pediatrics, 219 Bryant Street, Buffalo, NY 14222, USA E-mail: [email protected]Search for more papers by this authorM. Berger
Rainbow Babies and Children's Hospital, Case Western Reserve, Cleveland, Ohio, USA
Search for more papers by this authorR. H. Buckley
Duke University Medical Center, Department of Pediatrics, Durham, North Carolina, USA
Search for more papers by this authorC. H. Cunningham-Rundles
Mount Sinai Medical Center, New York, New York, USA
Search for more papers by this authorP. Fireman
Children's Hospital of Pittsburgh, Section of Allergy & Immunology, Pittsburgh, Pennsylvania, USA
Search for more papers by this authorM. Kaliner
Institute for Asthma & Allergy, Chevy Chase and Wheaton, Maryland, USA
Search for more papers by this authorH. D. Ochs
University of Washington School of Medicine, Health Science Building, Seattle, Washington, USA
Search for more papers by this authorS. Skoda-Smith
University of Florida, Shands Hospital, Gainesville, Florida, USA
Search for more papers by this authorM. T. Sweetser
University of Washington School of Medicine, Health Science Building, Seattle, Washington, USA
Search for more papers by this authorC. Lathia
Bayer Pharmaceuticals Corporation, West Haven, Connecticut, USA
Search for more papers by this authorAbstract
Background and Objectives A new intravenous immunoglobulin (IGIV) process has been developed that integrates efficient inactivation of enveloped virus, using caprylate, with immunoglobulin G (IgG) purification and caprylate removal by column chromatography. Two clinical studies were conducted to compare the pharmacokinetics of the new product, IGIV-C, 10% (Gamunex™, 10%), formulated with glycine, with the licensed solvent–detergent (SD)-treated intravenous immunoglobulin IGIV-SD, 10% (Gamimune®N, 10%), formulated with glycine, and IGIV-C, 5%, formulated with 10% maltose.
Materials and Methods Both studies were randomized, multicentre crossover trials of 18 and 20 (respectively) adult patients with primary humoral immune deficiency in which patients received one IGIV product for three consecutive periods (3–4 weeks) before crossing over to the other product. Pharmacokinetic parameters were determined after the third infusion of each product.
Results IGIV-C, 10% was bioequivalent to IGIV-SD, 10%, with half-lives (t1/2) of 35 and 34 days, respectively. IGIV-C, 5%, was bioequivalent to IGIV-C, 10%, with t1/2 of 35 and 36 days, respectively. The products had comparable safety profiles.
Conclusions The pharmacokinetic profiles observed in these trials indicate that IGIV-C, 10% may replace, and be administered in a manner similar to, IGIV-SD, 10%.
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