HAE is a rare, inherited disease that results in C1 esterase inhibitor (C1-INH) deficiency, the primary regulator of inflammation and vascular permeability. As a result of the deficiency, people living with HAE develop acute, recurrent episodes of localized edema, which may occur in the extremities, abdomen, face, and throat, and which can be fatal if not properly treated.4Learn about diagnosing HAE
HAE is often misdiagnosed because the symptoms mimic those of several common conditions, including allergic angioedema.4
It’s important to determine the difference between GI problems, allergic angioedema, and HAE because the pathophysiology and the treatment of the diseases are different.
HAE can be confirmed with blood tests to evaluate C4 serum concentration and C1-INH function.13
BERINERT treats the two most common types of HAE (Type I and Type II).
Type I: The body does not produce enough C1 esterase inhibitor (C1-INH). Approximately 85% of people living with HAE have type I.4
Type II: The body produces C1-INH that does not function correctly. Approximately 15% of people living with HAE have type II. 4
BERINERT is not indicated for treating HAE with normal C1-INH. This is a very rare form of HAE that occurs despite normal C1-INH levels and/or function.
Patients with HAE experience angioedema attacks because they lack functioning C1 esterase inhibitor (C1-INH).4 BERINERT addresses the root cause of HAE attacks by replacing missing or dysfunctional C1-INH to stop attacks.
BERINERT is the only C1-INH approved for on-demand treatment of acute abdominal, facial, or laryngeal attacks of HAE in adults and pediatrics.
BERINERT is an intravenous infusion that patients can self-administer after proper training by a healthcare professional.
BERINERT provides fast onset of relief from HAE attacks in as little as:
†Median time to onset of relief.
On-demand treatment helps patients take control of their HAE by treating at the first sign of an HAE attack, which can occur suddenly, frequently, and without warning.
Because attacks can occur even in patients on prophylactic HAE therapy, the WAO Guidelines for the Management of HAE state that patients should have on-demand medication available at all times.13
Yes. 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).
No serious adverse events or adverse events leading to discontinuation of treatment occurred within 4 hours after study treatment.1
Adverse reactions occurring up to 4 hours after initial infusion in more than 4% of subjects, irrespective of causality, included nausea, dysgeusia, and abdominal pain.*
*The following abdominal symptoms were identified in the protocol as associated with HAE abdominal attacks: abdominal pain, bloating, cramps, nausea, vomiting, and diarrhea.
BERINERT is made from human blood. BERINERT and the human plasma from which it's made have been carefully processed and screened to remove or inactivate known viruses.
BERINERT is given as an intravenous infusion that, with training, can be self-administered or infused by a caregiver.
BERINERT offers a weight-based approach to provide an individualized dose of C1-INH during an attack.
The recommended BERINERT dosage is 20 units (IU) per kilogram body weight, with a recommended infusion rate of 4 mL/minute. For example, a 70-kg patient would require 1400 IU, infused over 7 minutes.
When stored at temperatures of 2-30°C (36-86°F), BERINERT is stable for the period indicated by the expiration date on the carton and vial label.
BERINERT Connect, formerly kown as B.E.N., is a comprehensive support network for healthcare professionals and patients who depend on BERINERT. BERINERT Connect provides access to a range of individualized support programs with a single phone call.
You or your patients can call BERINERT Connect at 1-877-236-4HAE (1-877-236-4423), Monday–Friday, 8 AM–8 PM ET.
The BERINERT Co-Pay Benefit* is a financial assistance program designed to help pay for eligible out-of-pocket expenses—up to $12,000 per year.
*The BERINERT Co-Pay Benefit is available for new or existing BERINERT patients. Patients MUST be 12 years of age or older, a U.S. resident, and insured in the U.S. Patients covered by state- or federally funded programs, such as Medicare, Medicaid, and Veterans Health Insurance, are not eligible.
BERINERT Advocates are HAE patients who offer guidance and support to your HAE patients who are new to BERINERT. Your patient receives a helping hand from experienced HAE patients who can answer nonmedical questions related to their BERINERT therapy.
Starting a new patient on BERINERT is an easy process, and our BERINERT Care Coordinators can guide you and your staff the entire way.
If you have any questions while completing the BERINERT Prescription Referral Form, please contact your local CSL Behring representative, or call BERINERT Connect at 1-877-236-4HAE (1-877-236-4423).
CSL Behring is dedicated to making BERINERT available to patients and healthcare professionals when and where it is needed. BERINERT is available through a range of national and regional specialty pharmacies and distributors.
For contact information for these organizations, please call BERINERT Connect at 1-877-236-4HAE (1-877-236-4423).
CSL Behring is a world leader in specialty biopharmaceuticals and is committed to people around the world with rare and serious conditions, such as HAE. We are dedicated to making a difference in the HAE community through innovation, quality manufacturing, and support and education for patients and families affected by HAE.