국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
HUMAN C1-ESTERASE INHIBITOR (UNII: 6KIC4BB60G) (HUMAN C1-ESTERASE INHIBITOR - UNII:6KIC4BB60G)
CSL Behring GmbH
HUMAN C1-ESTERASE INHIBITOR
HUMAN C1-ESTERASE INHIBITOR 2000 [iU] in 4 mL
HAEGARDA is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older. HAEGARDA is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or its excipients [see Description (11)]. Risk Summary There are no prospective clinical data from HAEGARDA use in pregnant women. C1-INH is a normal component of human plasma. Animal developmental or reproduction toxicity studies have not been conducted with HAEGARDA. In the U.S. general population, the estimated background risk of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. Data In a retrospective case collection study, 22 pregnant women with type I HAE and ranging in age from 20 to 38 years received C1-INH doses of 500 or 1000 IU per I.V. administration for the treatmen
HAEGARDA is supplied in a kit containing a lyophilized powder in a single-dose vial. HAEGARDA is packaged with Sterile Water for Injection, USP (4 mL for reconstitution of 2000 IU or 5.6 mL for reconstitution of 3000 IU) and one Mix2Vial filter transfer set. Not made with natural rubber latex. Storage and Handling
Biologic Licensing Application
HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN)- HUMAN C1- ESTERASE INHIBITOR CSL BEHRING GMBH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HAEGARDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HAEGARDA. HAEGARDA (C1 ESTERASE INHIBITOR SUBCUTANEOUS [HUMAN]) FOR SUBCUTANEOUS INJECTION, FREEZE-DRIED POWDER FOR RECONSTITUTION INITIAL U.S. APPROVAL: 2017 RECENT MAJOR CHANGES Indications and Usage (1) 09/2020 INDICATIONS AND USAGE HAEGARDA is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older. (1) DOSAGE AND ADMINISTRATION FOR SUBCUTANEOUS USE AFTER RECONSTITUTION ONLY. Administer 60 International Units per kg body weight twice weekly (every 3 or 4 days). (2) Reconstitute HAEGARDA prior to use using Sterile Water for Injection, USP. (2.1) Use a silicone-free syringe for reconstitution and administration. (2.1) Administer at room temperature within 8 hours after reconstitution. (2.1) DOSAGE FORMS AND STRENGTHS HAEGARDA is available as a white lyophilized powder supplied in single-dose vials containing 2000 or 3000 International Units (IU) of C1-INH. (3) CONTRAINDICATIONS Do not use in patients with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis to C1-INH preparations or its excipients. (4) WARNINGS AND PRECAUTIONS Severe hypersensitivity reactions may occur. In case of severe hypersensitivity, discontinue HAEGARDA administration and institute appropriate treatment. Epinephrine should be immediately available for treatment of severe hypersensitivity reaction. (5.1) At the recommended subcutaneous (S.C.) dose, a causal relationship between thromboembolic events (TEEs) and the use of HAEGARDA has not been established. However, thrombosis has occurred in treatment attempts with high doses of C1-INH intravenous (I.V.) for prevention or therapy of capillary l 전체 문서 읽기