Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54)
BAXALTA US INC.
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 250 [iU] in 5 mL
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
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
Biologic Licensing Application
ADYNOVATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED BAXALTA US INC. ---------- 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 Lire le document complet