Frequently asked questions

About HAE

What is hereditary angioedema (HAE)?

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.4

Learn about diagnosing HAE

How can I differentiate between HAE and conditions that present with similar symptoms?

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

Learn 8 simple questions you can ask your patients to help determine if further testing is needed

About BERINERT

Which types of HAE does BERINERT treat?

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.

Explore using C1-INH therapy to address C1-INH deficiency

How does BERINERT treat HAE?

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.

Learn more about how C1-INH therapy addresses the root cause of HAE attacks

How fast does BERINERT provide relief?

BERINERT provides fast onset of relief from HAE attacks in as little as:

  • 15 minutes for laryngeal attacks*
  • 48 minutes for abdominal/facial attacks*
*Median time to complete resolution of HAE symptoms was 4.9 hours in a phase 3 clinical trial and 8.4 hours in an open-label extension.

Median time to onset of relief.

Explore fast relief from HAE attacks with BERINERT

How does on-demand treatment benefit my patients?

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

Learn about rapid C1-INH uptake with self-administered IV infusion

Has the safety of BERINERT been evaluated in pediatric patients?

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).

Learn more about BERINERT safety in adults and pediatrics

What were the adverse reactions in the clinical trials?

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.

Learn more about BERINERT safety in adults and pediatrics

What is the manufacturing process for BERINERT?

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.

Learn more about how BERINERT is manufactured

Dosing and self-administration

How is BERINERT administered?

BERINERT is given as an intravenous infusion that, with training, can be self-administered or infused by a caregiver.

Get more information about reconstituting and self-administering BERINERT

What is the recommended BERINERT dosage?

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.

Learn more about individualized, weight-based dosing

What is the benefit of room-temperature storage?

Room-temperature storage means that convenient relief is ready anytime, anywhere. BERINERT is ready to use, easy to transport, and can be kept at home or any place where the temperature is between 36°F and 77°F for up to 30 months.

Learn about BERINERT dosing and self-administration

Support, resources, and billing

What is BERINERT ConnectSM?

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.

Explore services and support that BERINERT Connect offers

Is there financial assistance to help my patients afford BERINERT?

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.

Discover more financial assistance available to eligible patients

Is there a support network for my HAE patients starting BERINERT?

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.

Discover more BERINERT Connect services

How do I start a patient on BERINERT?

Starting a new patient on BERINERT is an easy process, and our BERINERT Care Coordinators can guide you and your staff the entire way.

The first step is to download and fill out the BERINERT Prescription Referral Form. Fax the form to BERINERT Connect at 1-866-415-2162.

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).

Learn more about the helpful services of BERINERT Connect

How do I order BERINERT?

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).

Get reimbursement and coding information

What is the CSL Behring commitment to people affected by HAE?

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.

Find out more about CSL Behring's 40-year commitment to the HAE community

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