KOGENATE FS (antihemophilic factor- recombinant kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Bayer HealthCare LLC

INN (Tarptautinis Pavadinimas):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Sudėtis:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 1000 [iU] in 2.5 mL

Terapinės indikacijos:

Kogenate® FS is a recombinant antihemophilic factor indicated for: Kogenate FS is not indicated for the treatment of von Willebrand disease. Kogenate FS is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). There are no data with Kogenate FS use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with Kogenate FS. It is also not known whether Kogenate FS can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 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. There is no information regarding the presence of Kogenate FS 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 Kogenate FS and any potential adverse effects on the breastfed child from Kogenate FS or from the underlying maternal condition. Safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. Children, in comparison to adults, present higher factor VIII clearance values and, thus, lower half-life and recovery of factor VIII. This may be due to differences in body composition.13 Account for this difference in clearance when dosing or following factor VIII levels in the pediatric population [see Clinical Pharmacology (12.3)] . Routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. This data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see Clinical Studies (14)] . Clinical studies with Kogenate FS did not include patients aged 65 and over. Dose selection for an elderly patient should be individualized.

Produkto santrauka:

How Supplied Kogenate FS with vial adapter, with 15-micrometer filter and a prefilled diluent syringe, which together serve as an alternative needleless reconstitution system, is supplied in the following single use glass vial sizes. A prefilled diluent syringe containing Sterile Water for Injection, USP, a sterile vial adapter for reconstitution, and an administration set are also provided. Kit NDC Number Approximate FVIII Activity (IU) Diluent (mL) 0026-3782-25 250 2.5 0026-3783-35 500 2.5 0026-3785-55 1000 2.5 0026-3786-65 2000 5.0 0026-3787-75 3000 5.0 Actual factor VIII activity in IU is stated on the label of each Kogenate FS Vial. Use the actual potency as indicated on the vial label to calculate the dose. Storage and Handling The product vial and diluent syringe are not made with natural rubber latex. Product as Packaged for Sale Product After Reconstitution

Autorizacija statusas:

Biologic Licensing Application

Prekės savybės

KOGENATE FS- ANTIHEMOPHILIC FACTOR (RECOMBINANT)
BAYER HEALTHCARE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KOGENATE FS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR KOGENATE FS.
KOGENATE FS (ANTIHEMOPHILIC FACTOR [RECOMBINANT], FORMULATED WITH
SUCROSE)
FOR INTRAVENOUS USE, LYOPHILIZED POWDER FOR RECONSTITUTION WITH VIAL
ADAPTER
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
Kogenate FS is an Antihemophilic Factor (Recombinant) indicated for:
•
•
•
•
Kogenate FS is not indicated for the treatment of von Willebrand
disease (1).
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
•
CONTROL OF BLEEDING EPISODES AND PERIOPERATIVE MANAGEMENT (2.1):
•
•
•
For routine prophylaxis in adults: 25 units per kg three times a week
(2.1).
For routine prophylaxis in children: 25 units per kg every other day
(2.1).
DOSAGE FORMS AND STRENGTHS
Available as lyophilized powder in single use vials containing
nominally 250, 500, 1000, 2000, and 3000 IU (3). Kogenate FS
is provided with a sterile vial adapter with 15-micrometer filter and
a prefilled diluent syringe, which together serve as an
alternative needleless reconstitution system.
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 (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥4%) in clinical trials are
inhibitor formation (neutralizing antibodies) in previously
untreated and minimally treated patients (PUPs and MTPs),
skin-associated hypersensitivity reactions (e.g., rash, pruritus,
urticaria), infusion site reactions (e.g., inflammation, pain), and
central venous access device (CVAD) associated infections
(6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYER HEALTHCARE AT
1-888-842-2937 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
On-demand treatme