ADVATE (antihemophilic factor- recombinant kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54)

Disponível em:

Takeda Pharmaceuticals America, Inc.

DCI (Denominação Comum Internacional):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Composição:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 125 [iU] in 1 mL

Indicações terapêuticas:

ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for: - Control and prevention of bleeding episodes. - Perioperative management. - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ADVATE is not indicated for the treatment of von Willebrand disease. ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione). Risk Summary There are no data with ADVATE use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ADVATE. It is not known whether ADVATE can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. In the U.S. general popu

Resumo do produto:

How Supplied ADVATE in a BAXJECT III system is packaged with 2 mL or 5 mL of Sterile Water for Injection, one Terumo Microbore Infusion set (2 mL only), one full prescribing physician insert, and one patient insert. ADVATE is available in single-dose vials that contain the following nominal product strengths: Actual factor VIII activity in International Units is stated on the label of each ADVATE housing or carton. Not made with natural rubber latex. Storage and Handling

Status de autorização:

Biologic Licensing Application

Características técnicas

ADVATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT)
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADVATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADVATE.
ADVATE [ANTIHEMOPHILIC FACTOR (RECOMBINANT)] LYOPHILIZED POWDER FOR
RECONSTITUTION, FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
ADVATE is a recombinant antihemophilic factor indicated for use in
children and adults with hemophilia A
for:
Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes.
ADVATE is not indicated for the treatment of von Willebrand disease.
(1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INJECTION AFTER RECONSTITUTION ONLY. (2)
Each vial of ADVATE contains the labeled amount of recombinant factor
VIII in International Units (IU). (2.1)
Control and Prevention of Bleeding Episodes and Perioperative
Management (2.1)
Dose (IU) = body weight (kg) × desired factor VIII rise (IU/dL or %
of normal) × 0.5 (IU/kg per IU/dL).
Determine treatment frequency based on type of bleeding episode.
Routine Prophylaxis (2.1)
20 to 40 IU per kg every other day (3 to 4 times weekly).
Alternatively, use every third day dosing regimen targeted to maintain
FVIII trough levels ≥1%.
DOSAGE FORMS AND STRENGTHS
ADVATE is available as a lyophilized powder in single-use vials
containing nominally 250, 500, 1000, 1500,
2000, 3000 or 4000 IU. (3)
CONTRAINDICATIONS
Do not use in patients who have life-threatening hypersensitivity
reactions, including anaphylaxis, to
mouse or hamster protein or other constituents of the product
(mannitol, trehalose, sodium chloride,
histidine, Tris, calcium chloride, polysorbate 80, and/or
glutathione). (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, may occur. Patients
may develop hypersensitivity to
mouse or hamster protein, which is present in trace amounts in the
produc