FDA Approves New BERINERT® Administration Kit (C1 Esterase Inhibitor, Human (Intravenous)) for Greater Patient Convenience
KING OF PRUSSIA, PA., August 3, 2021 / PRNewswire / – CSL Behring, a world leader in biotherapy has received approval from the United States Food and Drug Administration (FDA) for its additional application (submitted August 30, 2020) for the co-packaging of a convenience administration kit with its BERINERT product, indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients. Combination product packaging will improve the patient experience by providing ready-to-use essential infusion supplies that are packaged more efficiently. It will also reduce the burden and responsibility of distributing pharmacies specializing in the provision of separate administration materials.
HAE is a rare, genetic, and potentially fatal disease that causes painful, potentially debilitating, and unpredictable episodes of swelling in the abdomen, larynx, face, and extremities, among other parts of the body. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps control swelling.
“HAE affects my daily life; with the worries and stress of not only maintaining my own health as a patient, but also that of my child who also has HAE, ”said Machelle, a person living with HAE. “Whether or not you are on preventive treatment, being ready to treat an HAE attack quickly is of the utmost importance. BERINERT is the only C1 esterase (C1-INH) inhibitor approved to treat acute abdominal, facial or laryngeal HAE attacks in adults and pediatric patients. In accordance with the World Allergy Organization’s guidelines for the management of HAE, it is recommended that all patients have sufficient on-demand medication for two attacks and that they always carry medication on demand. request.
The package of the combination product will now include a 10ml silicone-free syringe as well as an IV kit and butterfly needle and is expected to be on sale in the third quarter of 2021.
BERINERT is a plasma-derived C1 esterase inhibitor (human) indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) attacks in adult and pediatric patients. The safety and efficacy of BERINERT in preventing HAE attacks have not been established.
CSL Behring has marketed its C1 esterase inhibitor concentrate, BERINERT, in Germany for over 30 years. The product is also approved and marketed in more than 20 European countries, United States, Argentina, Australia, Canada, Israel, Japan and South Korea.
Important safety information
BERINERT®, C1 esterase inhibitor (human), is contraindicated in people with a history of potentially fatal systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).
Monitor patients for the first signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, discontinue administration of BERINERT immediately and initiate appropriate treatment. Epinephrine must be immediately available for the treatment of severe acute hypersensitivity reactions.
Serious arterial and venous thromboembolic (TE) events have been reported following the administration of recommended doses of C1 esterase inhibitors (humans) to patients with HAE. Risk factors may include the presence of an indwelling venous catheter / access device; history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and stillness. Weigh the benefits / risks before administering to patients with known risk factors for TE events and monitor these patients closely during and after administration of BERINERT. TE events have also been reported with C1 esterase inhibitor products (humans) when used for unapproved indications at doses above the recommended doses.
Trained patients can self-administer BERINERT as soon as they detect an HAE attack. Advise patients to seek medical attention immediately after self-administration for laryngeal attacks and to seek medical attention if the progression of an attack makes them unable to properly prepare or administer the dose of BERINERT.
BERINERT is derived from human plasma. The risk of transmission of infectious agents, including viruses and theoretically agents of Creutzfeldt-Jakob disease (CJD) and its variant form (vCJD), cannot be completely eliminated.
The most serious side effect reported in subjects who received BERINERT in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia was the most frequently reported adverse reaction in more than 4% of subjects and more frequently than in the placebo group.
BERINERT has not been evaluated in pregnant or breastfeeding women and should only be used 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 BERINERT’s full prescribing information at http://www.BERINERT.com/prescriber-information.aspx
To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About CSL Behring
CSL Behring is a world leader in biotherapy driven by its promise to save lives. Focused on the needs of patients using the latest technologies, the company develops and offers innovative therapies used to treat bleeding disorders, primary immune deficiencies, hereditary angioedema, respiratory diseases and neurological disorders. The company’s products are also used in cardiac surgery, in the treatment of burns and to prevent hemolytic diseases of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Mother Society, CSL Limited (ASX: CSL; USOTC: CSLLY), headquartered at Melbourne, Australia, employs more than 27,000 people worldwide and provides life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
SOURCE CSL Behring