HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN)- human c1-esterase inhibitor kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

HUMAN C1-ESTERASE INHIBITOR (UNII: 6KIC4BB60G) (HUMAN C1-ESTERASE INHIBITOR - UNII:6KIC4BB60G)

MAH:

CSL Behring GmbH

INN:

HUMAN C1-ESTERASE INHIBITOR

composition:

HUMAN C1-ESTERASE INHIBITOR 2000 [iU] in 4 mL

therapeutic_indication:

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

leaflet_short:

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

authorization_status:

Biologic Licensing Application

SPC

HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN)- HUMAN C1-
ESTERASE INHIBITOR
CSL BEHRING GMBH
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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