Fast relief with proven safety

BERINERT is safe and effective, delivering fast, sustained relief from acute HAE attacks in adult and pediatric patients.

Fast, sustained relief

BERINERT significantly shortens the duration of laryngeal and acute abdominal/facial HAE attacks.

Fast relief for laryngeal attacks.

The median time to onset of symptom relief was 15 minutes.*

Less than an hour to relief for abdominal or facial attacks.

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

In >90% of HAE attacks, patients showed symptom relief within 1 hour after receiving BERINERT*2

Onset of symptom relief
<1 hour <4 hours
93.2% 99.2
*In an open-label study, onset of symptom relief was measured in 57 HAE patients (10–53 years of age) who had previously participated in the IMPACT 1 placebo-controlled clinical study following a single dose of BERINERT 20 IU/kg. Additional doses of Cl-INH concentration were given for some attacks.

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.

Proven safety profile in both adults and pediatrics

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%)

*The following abdominal symptoms were identified in the protocol as associated with HAE abdominal attacks: abdominal pain, bloating, cramps, nausea, vomiting, and diarrhea.

Safety in children and adolescents

  • A US-European Registry Study (N=18, age range 5–11 years) demonstrated safety similar to that observed in adults
  • Safety and efficacy were also evaluated in placebo-controlled and open-label extension studies (N=12, age range 10–16 years)

Pharmacokinetics was evaluated in 5 children

Pediatrics
(n=5)
Adults§
(n=5)
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.

No dose adjustments required for pediatric patients

Dosing is based on weight for all patients taking BERINERT.

BERINERT and pregnancy

  • In a retrospective case collection study, 20 pregnant women ranging in age from 20 to 35 years received BERINERT with repeated doses up to 3500 IU per HAE attack; these women reported no complications during delivery and no harmful effects on their 34 neonates
  • BERINERT should be given to a pregnant woman only if clearly needed
See fast, sustained relief with BERINERT
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