PMID- 15030521
OWN - NLM
STAT- MEDLINE
DCOM- 20040608
LR  - 20181113
IS  - 0009-9104 (Print)
IS  - 1365-2249 (Electronic)
IS  - 0009-9104 (Linking)
VI  - 136
IP  - 1
DP  - 2004 Apr
TI  - Increased risk of adverse events when changing intravenous immunoglobulin 
      preparations.
PG  - 111-3
AB  - Intravenous immunoglobulin (IVIG) therapy has represented a major advance in the 
      treatment of patients with primary immune deficiency disorders. In September 2000 
      a new IVIG formulation, Intragam P, was introduced into clinical use. Intragam P 
      is prepared by delipidation of pooled plasma followed by an ion exchange 
      chromatography step to eliminate immunoglobulin aggregates. It is then 
      pasteurized for 10 h at 60 degrees C for viral inactivation before storage at pH 
      4.25 in 10% maltose. We report initial clinical experience with this new 
      preparation. The details of adverse reactions of patients who received the new 
      preparation were gathered shortly after it became apparent there was a change in 
      IVIG formulation. Seven of 49 patients receiving Intragam P spontaneously 
      reported adverse effects, which were temporally related to infusions. 
      Subsequently, all seven patients have been able to tolerate the product with 
      prophylactic use of antihistamines and paracetamol. This case series indicates 
      that long-term tolerance of an older IVIG product does not necessarily equate to 
      tolerance to a newer product, even if technically superior. Caution should be 
      exercised when changing IVIG products, as they are not biologically equivalent.
FAU - Ameratunga, R
AU  - Ameratunga R
AD  - Department of Immunology, Auckland Hospital, Park Road, Auckland, New Zealand.
FAU - Sinclair, J
AU  - Sinclair J
FAU - Kolbe, J
AU  - Kolbe J
LA  - eng
PT  - Journal Article
PL  - England
TA  - Clin Exp Immunol
JT  - Clinical and experimental immunology
JID - 0057202
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Adult
MH  - Chemistry, Pharmaceutical
MH  - Child
MH  - Female
MH  - Humans
MH  - Immunoglobulins, Intravenous/*adverse effects/therapeutic use
MH  - Immunologic Deficiency Syndromes/*therapy
MH  - Male
MH  - Middle Aged
PMC - PMC1809000
EDAT- 2004/03/20 05:00
MHDA- 2004/06/21 10:00
PMCR- 2005/04/01
CRDT- 2004/03/20 05:00
PHST- 2004/03/20 05:00 [pubmed]
PHST- 2004/06/21 10:00 [medline]
PHST- 2004/03/20 05:00 [entrez]
PHST- 2005/04/01 00:00 [pmc-release]
AID - CEI2412 [pii]
AID - 10.1111/j.1365-2249.2004.02412.x [doi]
PST - ppublish
SO  - Clin Exp Immunol. 2004 Apr;136(1):111-3. doi: 10.1111/j.1365-2249.2004.02412.x.