Pharmacokinetics and tolerability of a new intravenous immunoglobulin preparation, IGIV-C, 10% (Gamunex, 10%).
OBJECTIVE
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.


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%.
Ballow
M
M
Division of Allergy/Immunology and Pediatric Rheumatologym Kaleida Hralth at The Children's Hospital of Buffalo SUNY/Buffalo, Department of Pediatrics, Buffalo, New York 14222, USA. ballow@acsu.buffalo.edu
Berger
M
M
Bonilla
F A
FA
Buckley
R H
RH
Cunningham-Rundles
C H
CH
Fireman
P
P
Kaliner
M
M
Ochs
H D
HD
Skoda-Smith
S
S
Sweetser
M T
MT
Taki
H
H
Lathia
C
C
D000328:Adult; D001247:Asthenia / Q000139:chemically induced; D002210:Caprylates; D005260:Female; D005998:Glycine; D006207:Half-Life; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000493:pharmacokinetics* / Q000633:toxicity*; D007153:Immunologic Deficiency Syndromes / Q000150:complications / Q000188:drug therapy; D008297:Male; D008320:Maltose; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D002210:Caprylates; D016756:Immunoglobulins, Intravenous; D008320:Maltose; C031492:octanoic acid; D005998:Glycine