"March 5, 2013 -- Spring allergy season is again off to an early start in many parts of the country, and doctors say there are some signs it may be even more miserable than usual this year.
Last year was the fourth warmest winter on re"...
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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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