BERINERT is safe and effective, delivering fast, sustained relief from acute HAE attacks in adult and pediatric patients.
BERINERT significantly shortens the duration of laryngeal and acute abdominal/facial HAE attacks.
The median time to onset of symptom relief was 15 minutes.*
The median time to onset of symptom relief was 48 minutes.†
|Laryngeal attacks||Acute abdominal or facial attacks|
|Median time to complete resolution of HAE symptoms||8.4 hours||4.9 hours1|
|Onset of symptom relief|
|<1 hour||<4 hours|
|The following adverse reactions* occurred up to 4 hours after initial infusion in more than 4% of subjects, irrespective of causality.†|
|Adverse reaction||BERINERT 20 IU/kg||Placebo group|
|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.
†The following abdominal symptoms were identified in the protocol as associated with HAE abdominal attacks: abdominal pain, bloating, cramps, nausea, vomiting, and diarrhea.
|Half-life||16.7 h||18.4 h|
|Mean residence time||24.0 h||26.4 h|
†Based on a 15 IU/kg dose, adjusted for baseline.
‡Age range: 6–13 years old.
§Aged ≥17 years old.
The clinical implication of these differences is unknown.
Dosing is based on weight for all patients taking BERINERT.