1st and only HAE treatment indicated for use in pediatrics. Learn more ►
Berinert on demand is an essential part of your treatment plan.

Help your patients take control with the only approved C1-INH treatment for acute HAE attacks in adult and pediatric patients.

Efficacy and Safety Berinert has proven efficacy and safety, delivering fast, sustained relief from an acute HAE attack.

In the I.M.P.A.C.T. 1 study, a randomized, double-blind, placebo-controlled trial, Berinert was shown to be safe and effective for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adults and adolescents. The safety and efficacy of Berinert for prophylactic therapy have not been established.12

Berinert alleviates symptoms of acute abdominal, facial, and laryngeal attacks of hereditary angioedema. In the study, the median time to onset of symptom relief was significantly shorter with Berinert than with placebo.12 In addition, the proportion of patients with worsened intensity of clinical HAE abdominal and facial symptoms between 2 hours and 4 hours after the start of treatment was significantly lower with Berinert than with placebo.12

*Peer supporters are not healthcare professionals or medical experts. For medical questions, patients should contact their physicians.

Efficacy
Safety
Pediatric
Use

Fast Relief Efficacy

Self-reported relief symptoms, within 4 hours by attack type

Attack type Berinert 20 IU/kg body weight
(Abdominal subjects = 34)
(Facial subjects = 9)
(Other subjects = 0)
Placebo group
(Abdominal subjects = 33)
(Facial subjects = 8)
(Other subjects = 1)*
Abdominal 24 (70.6%) 15 (45.5%)
Facial 6 (66.7%) 3 (37.5%)

*Laryngeal edema initially classified as facial edema

In the I.M.P.A.C.T. 2 study, a non-placebo extension study, median time to onset of relief in patients being treated for laryngeal HAE attacks was 15 minutes.

Half-life

The pharmacokinetics of Berinert were evaluated in an open-label, uncontrolled, single-center study, in subjects with either mild or severe HAE. The study showed that Berinert has a half-life of 21.9 ± 1.7 (16.5–24.4) hours and a mean residence time of 31.5 ± 2.4 (23.7–35.2) hours.

Efficacy established in pediatrics and adults

In clinical trials, patients experienced the following when treated for acute abdominal or facial attacks:

  • Median time to onset of symptom relief was 48 minutes*†
  • Median time to complete resolution of HAE symptoms was 4.9 hours*†

In clinical trials, patients experienced the following when treated for laryngeal attacks:

  • Median time to onset of symptom relief was 15 minutes
  • Median time to complete resolution of HAE symptoms was 8.4 hours

*The safety profile observed in the pediatric population was similar to that observed in adults.
In a clinical trial, onset of relief was experienced within 4 hours by 69.8% of the treatment group and 42.9% of the placebo group. For subjects who did not respond within that time frame, the study design allowed use of rescue medications as follows: placebo for 20 IU/kg body weight for the Berinert treatment group and 20 IU/kg body weight Berinert for the placebo group.

Berinert Proven Safety

No serious adverse events or adverse events leading to discontinuation of treatment occurred within 4 hours after study treatment.12

Adverse reactions occurring up to 4 hours after initial infusion in more than 4% of subjects, irrespective of causality.

Adverse reactions Number (%) of subjects reporting adverse reactions Berinert 20 IU/kg (n=43) Number (%) of subjects reporting adverse reactions Placebo group (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 study protocol specified that adverse events that began within 72 hours of blinded study medication administration, irrespective of the investigator's assessment of causality, were to be classified as at least possibly related to study medication (ie, adverse reactions).

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

Safety proven in pediatrics

  • In clinical studies, the safety profile seen in pediatric population was similar to that observed in adults. This was based on placebo-controlled and open-label extension studies that included 12 pediatric patients with HAE (age range: 10-16 years), as well a US-European Registry Study of 18 pediatric patients (age range: 5-11 years)
  • The pharmacokinetics of Berinert were evaluated in an open-label, uncontrolled, single-center study involving 40 patients, including 5 pediatric patients

Pharmacokinetics were evaluated in pediatrics and adults*

Pediatrics (6 - 13 yrs)
(N=5)
Adults (≥17 yrs)
(N=35)
Half-Life 16.7 hours 18.4 hours
Mean Residence Time 24.0 hours 26.4 hours
*Based on a 15 IU/kg dose
The clinical implication of these differences is unknown

No dose adjustments are required for pediatric patients

  • Dosing is based on weight for all patients on Berinert

Save on Co-Pays: The Berinert Co-Pay BENefit™ may cover up to $12,000 of your eligible out-of-pocket expenses per year.

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Manufacturing Quality

The preparation of Berinert includes a combination of pasteurization, hydrophobic interaction chromatography and nanofiltration.

Home About Berinert Efficacy and Safety
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Important Safety Information

BERINERT®, C1 Esterase Inhibitor (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients. The safety and efficacy of BERINERT for prophylactic therapy have not been established.

BERINERT is contraindicated in individuals with a history of life-threatening systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).

Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of BERINERT and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.

Serious arterial and venous thromboembolic (TE) events have been reported following administration of recommended doses of C1 Esterase Inhibitor (Human) products to patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after BERINERT administration. TE events also have been reported with C1 Esterase Inhibitor (Human) products when used for unapproved indications at higher than recommended doses.

Appropriately trained patients may self-administer BERINERT upon recognition of an HAE attack. Advise patients to seek medical attention immediately following selfadministration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of BERINERT.

BERINERT is derived from human plasma. The risk of transmission of infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), cannot be completely eliminated.

The most serious adverse reaction reported in subjects who received BERINERT in clinical studies was an increase in severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.

BERINERT has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. In clinical trials, the half-life of BERINERT was shorter and clearance was faster in children than in adults; the clinical implication of this difference is not known.

Please see full prescribing information for BERINERT, including the patient product information.

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© 2017 CSL Behring. The product information presented on this site is intended for US residents only. BRN/03-13-0059(1)d