ADYNOVATE- antihemophilic factor (recombinant) pegylated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

BAXALTA US INC.

INN (International Name):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Sammensetning:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 5 mL

Indikasjoner:

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for: - On-demand treatment and control of bleeding episodes - Perioperative management - Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease. ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80). Risk Summary There are no data with ADYNOVATE use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ADYNOVATE. It is unknown whether ADYNOVATE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ADYNOVATE should be given to a pregnant woman only

Produkt oppsummering:

How Supplied ADYNOVATE is supplied in packages comprised of a single-use vial containing nominally (approximately) 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU) of factor VIII potency, a diluent vial containing 2 mL or 5 mL of sterile Water for Injection (sWFI), a BAXJECT II Hi-Flow Needleless Transfer Device, and one Terumo Microbore Infusion set (2 mL only). 2000 and 3000 IU will only be supplied with 5 mL Sterile Water for Injection. Components not made with natural rubber latex. Actual factor VIII activity in IU is stated on the label of each ADYNOVATE carton and vial. Storage and Handling

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

ADYNOVATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED
BAXALTA US INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADYNOVATE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ADYNOVATE.
ADYNOVATE, ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION.
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indication and Usage (1)
12/2016
Dosage and Administration (2)
12/2016
INDICATIONS AND USAGE
ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human
antihemophilic factor indicated in children and
adults with hemophilia A (congenital factor VIII deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use
ADYNOVATE is not indicated for the treatment of von Willebrand
disease. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY
One unit per kilogram body weight will raise the factor VIII level by
2% international units per deciliter (IU per dL).
Each vial of ADYNOVATE is labeled with the actual amount of
recombinant factor VIII present in IU. (2.1)
On-demand treatment and control of bleeding episodes and perioperative
management:
Estimated Increment of factor VIII (IU/dL or % of normal) = [Total
Dose (IU)/body weight (kg)] × 2 (IU/dL per
IU/kg)
Dose (IU) = Body Weight (kg) × Desired factor VIII Rise (IU/dL or %
of Normal) × 0.5 (IU/kg per IU/dL)
Routine prophylaxis: Administer 40-50 IU per kg body weight 2 times a
week (Starting dose of 55 IU per kg body
weight 2 times a week patients <12 years of age with a maximum of 70
IU per kg).
Inject intravenously over a period of less than or equal to 5 minutes
(maximum infusion rate 10 mL per min). (2.3)
DOSAGE FORMS AND STRENGTHS
ADYNOVATE is available as a lyophilized powder in single-use vials
containing nominally (approximately) 250, 500, 750,
1000, 1500, 2000, or 3000 international un