OBIZUR (antihemophilic factor- recombinant, porcine sequence kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

SUSOCTOCOG ALFA (UNII: 6892UQT2GK) (SUSOCTOCOG ALFA - UNII:6892UQT2GK)

Предлага се от:

Takeda Pharmaceuticals America, Inc.

INN (Международно Name):

SUSOCTOCOG ALFA

Композиция:

SUSOCTOCOG ALFA 500 [USP'U] in 1 mL

Терапевтични показания:

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A. Limitations of Use: - Safety and efficacy of OBIZUR has not been established in patients with baseline anti-porcine factor VIII inhibitor titer greater than 20 BU. - OBIZUR is not indicated for the treatment of von Willebrand disease. OBIZUR is contraindicated in patients: - Who have had life-threatening hypersensitivity reactions to OBIZUR or its components (including traces of hamster proteins). - With congenital hemophilia A with inhibitors (CHAWI) due to the high incidence of anamnestic reactions to human factor VIII (hFVIII) and porcine factor VIII (pFVIII) [see Adverse Reactions (6.1)] . Risk Summary There are no data with OBIZUR use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies ha

Каталог на резюме:

How Supplied OBIZUR is supplied as a white lyophilized powder in single-dose vials in the following package size: Each package contains one package insert and one of each of the components listed below: The actual amount of OBIZUR in units is stated on the label of each vial. Not made with natural rubber latex. Storage and Handling

Статус Оторизация:

Biologic Licensing Application

Данни за продукта

OBIZUR- ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OBIZUR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OBIZUR.
OBIZUR [ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE]
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Contraindications (4)
2/2023
INDICATIONS AND USAGE
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an
antihemophilic factor indicated for
the on-demand treatment and control of bleeding episodes in adults
with acquired hemophilia A. (1)
Limitations of Use:
Safety and efficacy of OBIZUR has not been established in patients
with a baseline anti-porcine factor
VIII inhibitor titer of greater than 20 BU. (1)
OBIZUR is not indicated for the treatment of von Willebrand disease.
(1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
Initial dose of OBIZUR is 200 units per kg. (2.1)
Titrate dose and frequency of administration based on factor VIII
recovery levels and individual clinical
response. (2.1)
Initial dosing below the recommended 200 U/kg has been associated with
lack of efficacy. (2.1)
DOSAGE FORMS AND STRENGTHS
OBIZUR is available as lyophilized powder for solution in single-dose
vials containing nominally 500 units
per vial. (3)
CONTRAINDICATIONS
Patients who have had life-threatening hypersensitivity reactions to
OBIZUR or its components,
including hamster protein. (4)
Patients with congenital hemophilia A with inhibitors (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, may occur. Should
symptoms occur, discontinue
OBIZUR and administer appropriate treatment. (5.1)
Development of inhibitory antibodies to OBIZUR has occurred and may
result in a lack of efficacy. (5.2)
Anamnestic reactions with rise in human factor VIII and/or recombinant
factor VIII, porcine sequence
inhibitors have occur