FEIBA- anti-inhibitor coagulant complex kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANTI-INHIBITOR COAGULANT COMPLEX (UNII: CS849DUN3M) (ANTI-INHIBITOR COAGULANT COMPLEX - UNII:CS849DUN3M)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

ANTI-INHIBITOR COAGULANT COMPLEX

Composition:

ANTI-INHIBITOR COAGULANT COMPLEX 500 [USP'U] in 20 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: - Control and prevention of bleeding episodes - Perioperative management - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. - Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. - Disseminated intravascular coagulation (DIC). - Acute thrombosis or embolism (including myocardial infarction). Risk Summary There are no data with FEIBA use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with FEIBA. It is also not known whether FEIBA can cause fetal harm when administered to a

Product summary:

How Supplied FEIBA is available in single-dose vials in the following nominal dosage strengths: The number of units of factor VIII inhibitor bypassing activity is stated on the label of each vial. FEIBA is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT II Hi-Flow Needleless Transfer Device, and one Package Insert. Not made with natural rubber latex. Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FEIBA- ANTI-INHIBITOR COAGULANT COMPLEX
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FEIBA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FEIBA.
FEIBA (ANTI-INHIBITOR COAGULANT COMPLEX)
FOR INTRAVENOUS USE, LYOPHILIZED POWDER FOR SOLUTION
INITIAL U.S. APPROVAL: 1986
WARNING: EMBOLIC AND THROMBOTIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THROMBOEMBOLIC EVENTS HAVE BEEN REPORTED DURING POST-MARKETING
SURVEILLANCE,
PARTICULARLY FOLLOWING THE ADMINISTRATION OF HIGH DOSES AND/OR IN
PATIENTS WITH
THROMBOTIC RISK FACTORS.
MONITOR PATIENTS RECEIVING FEIBA FOR SIGNS AND SYMPTOMS OF
THROMBOEMBOLIC EVENTS
(5.1, 6.2).
INDICATIONS AND USAGE
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in
hemophilia A and B patients with
inhibitors for:
Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes.
FEIBA is not indicated for the treatment of bleeding episodes
resulting from coagulation factor deficiencies
in the absence of inhibitors to factor VIII or factor IX. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY (2)
Each vial of FEIBA contains the labeled amount of factor VIII
inhibitor bypassing activity in units. (2)
TYPE OF BLEEDING
DOSE (UNIT/KG)
FREQUENCY/DURATION
Control and Prevention of
Bleeding
50 - 100
Determined by the type of bleeding episode
Perioperative
Management
50 - 100
Determined by the type of surgical intervention
Routine Prophylaxis
85
Every other day
Maximum injection or infusion rate must not exceed 2 units per kg of
body weight per minute. (2.3)
DOSAGE FORMS AND STRENGTHS
FEIBA is available as a lyophilized powder in single-dose vials
containing nominally 500, 1000, or 2500 units
per vial. (3)
CONTRAINDICATIONS
History of anaphylactic or severe hypersensitivity reactions to FEIBA
or any of its components, including
factors of th