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Adverse Reaction Overview
The most serious adverse events observed in clinical studies of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) have been death due to non-catheter related foreign body embolus, pre-eclampsia resulting in emergency C-section, stroke, and exacerbation of HAE attacks, none of which have been considered drug related.
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Twenty-four subjects were evaluated in study LEVP2005-1/B for routine prophylaxis.
There were no treatment-emergent serious adverse reactions in study LEVP2005-1/B.
Adverse reactions in trial LEVP2005-1/B that occurred in at least two subjects during CINRYZE (c1 esterase inhibitor [human] freeze dried powder) prophylaxis, irrespective of the causality assessment, are given in the following table:
Table 2: Adverse Reactions in Routine Prophylaxis Study LEVP2005-1/B
Irrespective of Causality
|Adverse Reaction||Number of Adverse Events|| Number of Subjects
(N = 24)
|Upper respiratory tract infection||3||3|
|Viral upper respiratory tract infection||5||3|
|Pain in extremity||2||2|
More than 9000 doses of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) have been administered to over 180 patients in all controlled and open label clinical studies. All patients were evaluated and found negative for seroconversion to parvovirus B19, Hepatitis B, Hepatitis C and HIV.
Read the Cinryze (c1 esterase inhibitor [human] freeze dried powder) Side Effects Center for a complete guide to possible side effects
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