BERINERT is safe and effective, delivering fast, sustained relief from acute HAE attacks in adult and pediatric patients.
|Acute abdominal or facial attacks||
|Median time to onset of symptom relief||48 minutes*||15 minutes†|
|Median time to complete resolution of HAE symptoms||4.9 hours1||8.4 hours|
|Onset of symptom relief|
|<1 hour||<4 hour|
In a randomized, double‑blind, placebo-controlled clinical trial, onset of relief was experienced within 4 hours by 69.8% of BERINERT treatment group and 42.9% of placebo group. For subjects who did not respond within that time frame, study design allowed use of rescue medications as follows: placebo for 20 IU/kg body weight BERINERT treatment group and 20 IU/kg body weight BERINERT for placebo group.
|The following adverse reactions‡ occurred up to 4 hours after initial infusion in more than 4% of subjects, irrespective of causality.§|
BERINERT 20 IU/kg
No. (%) of subjects reporting adverse reactions (n=43)
No. (%) of subjects reporting adverse reactions (n=42)
|Nausea§||3 (7%)||5 (11.9%)|
|Dysgeusia||2 (4.7%)||0 (0)|
|Abdominal pain§||2 (4.7%)||3 (7.1%)|
|Vomiting§||1 (2.3%)||3 (7.1%)|
|Diarrhea§||0 (0)||4 (9.5%)|
|Headache||0 (0)||2 (4.8%)|
Comprises adverse events that began within 4 hours of infusion; these events were considered adverse reactions irrespective of reported causality.
|Half-life (range)||16.7 (7.4-22.5) hours||18.4 (7.4-22.8) hours|
|Mean Residence Time (range)||24.0 (10.7-32.4) hours||26.4 (10.7-33.0) hours|
|The clinical implication of these differences is unknown.|