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• W1968477007 abstract "RationaleC1 esterase inhibitor (C1-INH) replacement therapy is recommended as a first-line therapy for treatment of acute attacks of hereditary angioedema (HAE). CSL Behring's human pasteurized C1 INH concentrate (Berinert) has been marketed since 1985 for the treatment of acute HAE attacks in Germany and numerous other countries.MethodsWe reviewed spontaneous reports of adverse drug reactions (ADRs) received by CSL Behring for its human pasteurized C1-INH concentrate, covering the 26-year period from 1985 until 30 June 2011.ResultsDuring the reporting period, human pasteurized C1-INH concentrate representing more than 570,000 treatments was distributed. A total of 121 cases of suspected ADRs were reported worldwide, with 71 cases covered by the product's known safety profile: allergic- or anaphylactic-type reactions (12; in very rare cases involving shock), chills and fever (4), injection site reactions (2), lack of effect (31), suspected virus transmission (6; not attributed to the product), and thrombosis (16). In 3 cases of thrombosis causality was assessed as unlikely. The other 13 cases of thrombosis occured during off-label use of the product, in cardiac surgery involving substantially higher doses than indicated in the label. Of 50 cases involving isolated reports of varying symptoms not covered by the known product safety profile (including reports where no ADRs occurred like product exposure during pregnancy and administration failure), causality to the product was established for only 1 case (lightheadedness and dizziness).ConclusionsThe human pasteurized C1-INH concentrate Berinert has a well-established long-term safety profile based on 26 years of post-marketing experience with more than 570,000 treatments. RationaleC1 esterase inhibitor (C1-INH) replacement therapy is recommended as a first-line therapy for treatment of acute attacks of hereditary angioedema (HAE). CSL Behring's human pasteurized C1 INH concentrate (Berinert) has been marketed since 1985 for the treatment of acute HAE attacks in Germany and numerous other countries. C1 esterase inhibitor (C1-INH) replacement therapy is recommended as a first-line therapy for treatment of acute attacks of hereditary angioedema (HAE). CSL Behring's human pasteurized C1 INH concentrate (Berinert) has been marketed since 1985 for the treatment of acute HAE attacks in Germany and numerous other countries. MethodsWe reviewed spontaneous reports of adverse drug reactions (ADRs) received by CSL Behring for its human pasteurized C1-INH concentrate, covering the 26-year period from 1985 until 30 June 2011. We reviewed spontaneous reports of adverse drug reactions (ADRs) received by CSL Behring for its human pasteurized C1-INH concentrate, covering the 26-year period from 1985 until 30 June 2011. ResultsDuring the reporting period, human pasteurized C1-INH concentrate representing more than 570,000 treatments was distributed. A total of 121 cases of suspected ADRs were reported worldwide, with 71 cases covered by the product's known safety profile: allergic- or anaphylactic-type reactions (12; in very rare cases involving shock), chills and fever (4), injection site reactions (2), lack of effect (31), suspected virus transmission (6; not attributed to the product), and thrombosis (16). In 3 cases of thrombosis causality was assessed as unlikely. The other 13 cases of thrombosis occured during off-label use of the product, in cardiac surgery involving substantially higher doses than indicated in the label. Of 50 cases involving isolated reports of varying symptoms not covered by the known product safety profile (including reports where no ADRs occurred like product exposure during pregnancy and administration failure), causality to the product was established for only 1 case (lightheadedness and dizziness). During the reporting period, human pasteurized C1-INH concentrate representing more than 570,000 treatments was distributed. A total of 121 cases of suspected ADRs were reported worldwide, with 71 cases covered by the product's known safety profile: allergic- or anaphylactic-type reactions (12; in very rare cases involving shock), chills and fever (4), injection site reactions (2), lack of effect (31), suspected virus transmission (6; not attributed to the product), and thrombosis (16). In 3 cases of thrombosis causality was assessed as unlikely. The other 13 cases of thrombosis occured during off-label use of the product, in cardiac surgery involving substantially higher doses than indicated in the label. Of 50 cases involving isolated reports of varying symptoms not covered by the known product safety profile (including reports where no ADRs occurred like product exposure during pregnancy and administration failure), causality to the product was established for only 1 case (lightheadedness and dizziness). ConclusionsThe human pasteurized C1-INH concentrate Berinert has a well-established long-term safety profile based on 26 years of post-marketing experience with more than 570,000 treatments. The human pasteurized C1-INH concentrate Berinert has a well-established long-term safety profile based on 26 years of post-marketing experience with more than 570,000 treatments." @default.
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• W1968477007 date "2012-02-01" @default.
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• W1968477007 title "Review of the Long-Term Safety of a Human Pasteurized C1 Inhibitor Concentrate" @default.
• W1968477007 doi "https://doi.org/10.1016/j.jaci.2011.12.114" @default.
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