The Food and Drug Administration (FDA) has approved the supplemental request for the co-packaging of a convenience administration kit for Berinert® (C1 esterase inhibitor, [human]) for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema in adult and pediatric patients.
Berinert is a lyophilized concentrate of C1 esterase inhibitor that is prepared from large pools of human plasma from US donors. The product is supplied as a single-dose vial containing 500 IU of lyophilized concentrate with 10mL of sterile water for intravenous (IV) use after reconstitution.
To reduce the burden on specialty pharmacies to supply separate administration materials, the new convenience administration kit will include a 10mL silicone-free syringe, an IV set and a butterfly needle. The new kit is expected to be available within the third quarter of 2021.
- FDA approves new Berinert® (C1 Esterase Inhibitor, [Human]) administration kit for increased patient convenience. News release. Associated Press. Accessed August 3, 2021. https://www.prnewswire.com/news-releases/fda-approves-new-berinert-c1-esterase-inhibitor-human-intravenous-administration-kit-for-increased-patient-convenience-301347095.html.
- Berinert [package insert]. Kankakee, IL: CSL Behring LLC; 2021.