BENEFIX (coagulation factor ix- recombinant kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (COAGULATION FACTOR IX RECOMBINANT HUMAN - UNII:382L14738L)

Available from:

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

INN (International Name):

COAGULATION FACTOR IX RECOMBINANT HUMAN

Composition:

COAGULATION FACTOR IX RECOMBINANT HUMAN 1000 [iU] in 5 mL

Therapeutic indications:

BeneFIX® , Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: Limitation of Use BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)] . BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. Risk Summary There are no data with BeneFIX use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with BeneFIX. It is not known whether BeneFIX can affect reproductive capacity or cause fetal harm when given to pregnant women. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Risk Summary There is no informa

Product summary:

How Supplied BeneFIX, Coagulation Factor IX (Recombinant), is supplied in kits that include single-use vials which contain nominally 250, 500, 1000, 2000, or 3000 IU per vial with sterile pre-filled diluent syringe, vial adapter reconstitution device, sterile infusion set, and two (2) alcohol swabs, one bandage, and one gauze pad. The drug product, diluents for injection and the rest of components included within the BeneFIX 250, 500, 1000, 2000 or 3000 IU kit are not made from natural rubber and natural rubber latex. Actual factor IX activity in IU is stated on the label of each vial. BeneFIX Nominal Strengths Color Code Kit NDC Number 250 International Units Yellow 58394-633-03 500 International Units Blue 58394-634-03 1000 International Units Green 58394-635-03 2000 International Units Red 58394-636-03 3000 International Units Grey 58394-637-03 Storage and Handling Product kit as packaged for sale Product after reconstitution The product does not contain a preservative and should be used within 3 hours.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BENEFIX- COAGULATION FACTOR IX (RECOMBINANT)
WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENEFIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENEFIX.
BENEFIX [COAGULATION FACTOR IX (RECOMBINANT)]
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
BeneFIX is a recombinant human blood coagulation factor IX indicated
for adults and children with
hemophilia B (congenital factor IX deficiency or Christmas disease)
for:
o
o
o
Limitations of Use
BeneFIX is not indicated for induction of immune tolerance in patients
with hemophilia B. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
•
•
Required units =
body weight (kg) × desired factor IX increase (IU/dL or % of normal)
× reciprocal of
observed recovery (IU/kg per IU/dL). (2.1)
•
•
DOSAGE FORMS AND STRENGTHS
BeneFIX is available as lyophilized powder in single-use vials
containing nominally 250, 500, 1000, 2000, or
3000 IU. (3)
CONTRAINDICATIONS
Do not use in patients who have manifested life-threatening, immediate
hypersensitivity reactions,
including anaphylaxis, to the product or its components, including
hamster protein. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
®
On-demand treatment and control of bleeding episodes. (1)
Perioperative management of bleeding. (1)
Routine prophylaxis to reduce the frequency of bleeding episodes. (1)
One international unit (IU) of BeneFIX per kilogram of body weight
increased the circulating activity of
factor IX as follows:
o
o
Adolescents/Adults (≥12 years): 0.8 ± 0.2 IU/dL (range 0.4 to 1.2
IU/dL). (2.1)
Children (<12 years): 0.7 ± 0.3 IU/dL (range 0.2 to 2.1 IU/dL). (2.1)
Determine the initial estimated dose using the following formula:
Dosage and duration of treatment with BeneFIX depend on the severity
of the factor IX deficiency, the
location and extent of bleeding, and the patient's clinical