Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Antihemophilic Factor Human (UNII: 839MOZ74GK) (Antihemophilic Factor Human - UNII:839MOZ74GK)
KEDRION BIOPHARMA, INC.
Antihemophilic Factor Human
Antihemophilic Factor Human 250 [iU] in 5 mL
KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). Limitation of Use KOĀTE is not indicated for the treatment of von Willebrand disease. KOĀTE is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to KOĀTE or its components. [see Description (11) ] Risk Summary There are no data with KOĀTE use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using KOĀTE. It is not known whether KOĀTE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. KOĀTE should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of KOĀTE in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KOĀTE and any potential adverse effects on the breast-fed infant from KOĀTE or from the underlying maternal condition. Safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. Subjects received 208 infusions of KOĀTE for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis. Children have shorter half-life and lower recovery of Factor VIII than adults. Because clearance of Factor VIII (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. Clinical studies of KOĀTE did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. Individualize dose selection for geriatric patients.
How Supplied KOĀTE is supplied in single-use vials containing 250, 500 or 1,000 IU of Factor VIII activity, packaged with 5 mL or 10 mL of Sterile Water for Injection, one sterile double-ended transfer needle, one sterile filter needle, and one sterile administration set. The actual amount of KOĀTE in IU is stated on each carton and vial label. Components used in the packaging of KOĀTE are not made with natural rubber latex. Strength NDC Number Carton (Kit) 250 IU 76125-250-20, 76125-253-25 or 76125-258-02 500 IU 76125-667-30, 76125-662-50 or 76125-661-02 1,000 IU 76125-672-50, 76125-674-10 or 76125-675-12 Storage and Handling
Biologic Licensing Application
KOATE - ANTIHEMOPHILIC FACTOR (HUMAN) KOATE - ANTIHEMOPHILIC FACTOR (HUMAN) KEDRION BIOPHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE KOĀTE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOĀTE. KOĀTE , ANTIHEMOPHILIC FACTOR (HUMAN) LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 1974 INDICATIONS AND USAGE KOĀTE is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). (1) Limitation of Use KOĀTE is not indicated for the treatment of von Willebrand disease. DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY. • Each vial of KOĀTE contains the labeled amount of Factor VIII in international units (IU). (2) • Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 • Frequency of KOĀTE administration is determined by the type of bleeding episode and the recommendation of the treating physician. DOSAGE FORMS AND STRENGTHS KOĀTE is available as a lyophilized powder for reconstitution in single-use vials of 250, 500, and 1,000 international units of Factor VIII activity. (3) CONTRAINDICATIONS Do not use in patients who have known hypersensitivity reactions, including anaphylaxis, to KOĀTE or its components. (4) WARNINGS AND PRECAUTIONS • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue KOĀTE and administer appropriate treatment. (5.1) • Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. (5.2) • Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B or AB blood g Perskaitykite visą dokumentą