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Immunotherapy. 2017 Oct;9(13):1071-1088. doi: 10.2217/imt-2017-0071. Epub 2017 Sep 18.

Gammaplex® 5 and 10% in the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

Author information

1
Allergy Partners of North Texas, 7777 Forest Lane, Building B, Suite 332, Dallas, TX 75230, USA.

Abstract

Immunoglobulin G is used to both prevent infection in primary immunodeficiency diseases (PIDs) and prevent bleeding in immune thrombocytopenic purpura. Gammaplex is a highly purified human intravenous immunoglobulin G available as 5 and 10% liquid formulations. Gammaplex 5% has proven efficacy and safety in PID and immune thrombocytopenic purpura, protecting against serious acute bacterial infections and treating bleeding by improving platelet counts, respectively. The therapeutic effect of Gammaplex 10% is expected to be similar to that of Gammaplex 5% based on demonstrated bioequivalence in a bridging study in PID. The availability of Gammaplex 10% provides another option to individualize therapy according to patient needs, allowing a 34% reduction in infusion time without compromising safety and tolerability.

KEYWORDS:

Gammaplex 10%; Gammaplex 5%; ITP; IVIG; PID; bioequivalence; efficacy; pharmacokinetics; safety

PMID:
29032734
DOI:
10.2217/imt-2017-0071
[Indexed for MEDLINE]

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