ELOCTATE (antihemophilic factor- recombinant, fc fusion protein kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

(1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) (UNII: 7PCM518YLR) ((1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) - UNII:7PCM51

Available from:

Biogen Inc.

INN (International Name):

--BLOOD-COAGULATION FACTOR VIII FUSION PROTEIN WITH IMMUNOGLOBULIN G1 , ,-BIS WITH IMMUNOGLOBULIN G1 --BLOOD-COAGULATION FACT

Composition:

(1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) 250 [iU] in 3 mL

Administration route:

INTRAVENOUS

Therapeutic indications:

ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: - On-demand treatment and control of bleeding episodes, - Perioperative management of bleeding, - Routine prophylaxis to reduce the frequency of bleeding episodes. Limitation of Use ELOCTATE is not indicated for the treatment of von Willebrand disease. ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or other constituents of the product. [see Description (11 )] Risk Summary There are no studies of ELOCTATE use in pregnant women to inform a drug-associated risk. The background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the U.S. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Animal reproductive and devel

Product summary:

How Supplied ELOCTATE is supplied in kits comprising a single use vial containing nominally, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 or 6000 international units (IU) of Factor VIII potency, a pre filled syringe with 3 mL sterile water for injection, and a sterile vial adapter (reconstitution device). The actual amount of ELOCTATE in IU is stated on the label and carton of each vial. Components used in the packaging of ELOCTATE contain no natural rubber latex. Storage and Handling Prior to reconstitution: After Reconstitution:

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ELOCTATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN
BIOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELOCTATE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ELOCTATE.
ELOCTATE [ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN]
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
08/2016
INDICATIONS AND USAGE
ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a
recombinant DNA derived, antihemophilic factor
indicated in adults and children with Hemophilia A (congenital Factor
VIII deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation of Use
ELOCTATE is not indicated for the treatment of von Willebrand disease.
(1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
Each vial of ELOCTATE is labeled with the amount of recombinant Factor
VIII in international units (IU or unit). One
unit per kilogram body weight will raise the Factor VIII level by 2%
(IU/dL). (2.1)
For on-demand treatment and control of bleeding episodes and
perioperative management, calculate dose using the
following formulas:
Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total
Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)
OR
Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise
(IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
For routine prophylaxis: 50 IU/kg every 4 days. Adjust dose based on
patient response with dosing in the range of 25-
65 IU/kg at 3-5 day intervals.
For routine prophylaxis in children less than 6 years of age: 50 IU/kg
twice weekly. Adjust dose based on patient
response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.
More frequent or higher doses up to 80 IU/kg
may be required. (2.1)
DOSAGE FORMS AND STRENGTHS
For injection: n