About BERINERT

Berinert-Logo

Connect with us

Meet with your CSL Behring Corporate Account Manager.

healthcare_systems_logo
Schedule a meeting

Driven by Our Promise™

CSL Behring innovates and collaborates to improve access and care for patients.

About hereditary angioedema (HAE)

HAE is a rare autosomal dominant genetic disorder affecting ~1 in 50K individuals. Patients with HAE are deficient in the C1 esterase inhibitor (C1-INH) protein or have malfunctioning C1-INH protein, which regulates the complement, contact, and coagulation cascades.1 Patients with HAE can have several attacks per week, which can range from mild to severe.2-4

BERINERT addresses the root cause of HAE attacks by replacing missing or dysfunctional C1-INH through an intravenous infusion, which quickly restores C1-INH levels.

  • C1-INH regulates multiple pathways
  • Restoring C1-INH prevents bradykinin generation2
  • C1-INH decreases vascular permeability
Explore more clinical information here.
arrow

What is BERINERT?

BERINERT is a plasma-derived concentrate of C1-INH indicated for the treatment of acute abdominal, facial, or laryngeal HAE attacks in adult and pediatric patients.

The safety and efficacy of BERINERT for prophylactic therapy have not been established.

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

What are the key benefits?

At the first sign of an HAE attack, BERINERT provides relief:

In as little as 15 minutes icon

In as little as 15 minutes

for laryngeal attacks*†
In as little as 48 minutes icon

In as little as 48 minutes

for abdominal/facial attacks*‡
In >90% of HAE attacks, icon

In >90% of HAE attacks,

patients showed symptom relief within 1 hour after receiving BERINERT5†

*Median time to onset of relief.

†In an open-label study, onset of symptom relief was measured in 57 HAE patients (aged 10-53 years) 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 concentrate 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 subjects in the BERINERT treatment group and 42.9% of subjects in the placebo group. For subjects who did not respond within that time frame, study design allowed use of rescue medications as follows: placebo for the 20 IU/kg body weight BERINERT treatment group and 20 IU/kg body weight BERINERT for the placebo group.

Want to learn more?

Meet with your CSL Behring Corporate Account Manager.

Schedule a meeting

Help us help you

Share your thoughts so we can further tailor our content.

Provide feedback
Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

Important Safety Information

BERINERT®, C1 Esterase Inhibitor (Human), 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 self-administration 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.

Indications

BERINERT 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.

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

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Lumry WR. Overview of epidemiology, pathophysiology, and disease progression in hereditary angioedema. Am J Manag Care. 2013;19(7)(suppl):s103-s110. 2. Fay A, Abinun M. Current management of hereditary angio-oedema (C’1 esterase inhibitor deficiency). J Clin Pathol. 2002;55(4):266-270. doi:10.1136/jcp.55.4.266 3. Zuraw BL. Clinical practice: hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036. doi:10.1056/NEJMcp0803977 4. Martinez-Saguer I, Cicardi M, Suffritti C, et al. Pharmacokinetics of plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the PASSION study. Transfusion. 2014;54(6):1552-1561. doi:10.1111/trf.12501 5. 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(12):1604-1611. doi:10.1111/j.1398-9995.2011.02702.x

BERINERT is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

BERINERT® is a registered trademark of CSL Behring GmbH.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

BRN-0045-OCT22

You are now leaving the current website.

Do you want to continue?

No Yes