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The maximum dose administered in clinical studies was 4000 Units given over approximately 5 hours (an average dose of 57 Units/kg) and 9000 Units given over a 7 day period. There have been no overdosages of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) reported during clinical studies.
In vitro and in vivo animal thrombogenicity studies with CINRYZE (c1 esterase inhibitor [human] freeze dried powder) showed a potential for clot formation when CINRYZE (c1 esterase inhibitor [human] freeze dried powder) was administered at doses 14 times the recommended clinical dose (greater than 200U/kg). Thrombotic events have been reported in association with C1 esterase inhibitor products when used off-label at high doses.6 Animal studies have supported a concern about the risk of thrombosis from intravenous administration of C1 esterase inhibitor products.7 (see Animal Toxicology and/or Pharmacology and Thrombotic events in WARNINGS AND PRECAUTIONS).
CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.
6. Arzneimittelkommission der Deutschen Aertzteschaft. Schwerwiegende Thrombenbildung nach Berinert HS. Dtsch Aerztebl. 2000; 97:B-864
7. Horstick, G et al, 2002. Circulation 104:3125-3131
Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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