Experience fast relief from HAE attacks
BERINERT is safe and effective, delivering fast, sustained relief from acute HAE attacks in adult and pediatric patients.
BERINERT significantly shortens the duration of acute abdominal, facial, or laryngeal HAE attacks
| Acute abdominal or facial attacks |
Laryngeal 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 |
In >90% of HAE attacks, patients showed symptom relief within 1 hour after receiving BERINERT†2
| Onset of symptom relief | |
|---|---|
| <1 hour | <4 hour |
| 93.2% | 99.2% |
*
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.
†
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 C1-INH concentration were given for some attacks.
Proven safety profile in both pediatric and adult patients
| 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
No. (%) of subjects reporting adverse reactions (n=43) |
Placebo group
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.
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)
|
Children# (N=5) |
Adults** (N=35) |
|
|---|---|---|
| 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. | ||
¶ Based on a 15 IU/kg dose, adjusted for baseline.
# Age range: 6–13 years old.
** Age range: ≥17 years old.
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 neonates3
- BERINERT should be given to a pregnant woman only if clearly needed
References: 1. Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol. 2009;129(4):801-808.
2. Craig TJ, Bewtra AK, Bahna SL, et al. C1 esterase inhibitor concentrate in 1085 hereditary angioedema attacks—final results of the I.M.P.A.C.T.2 study. Allergy. 2011;66:1604-1611.
3. Martinez-Saguer I, Rusicke E, Aygören-Pürsün E, et al. Characterization of acute hereditary angioedema attacks during pregnancy and breast-feeding and their treatment with C1 inhibitor concentrate. Am J Obstet Gynecol. 2010;203:131.e1-7.