ELOCTATE (antihemophilic factor- recombinant, fc fusion protein kit

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

EFMOROCTOCOG ALFA (UNII: 7PCM518YLR) (EFMOROCTOCOG ALFA - UNII:7PCM518YLR)

제공처:

Bioverativ Therapeutics Inc.

INN (국제 이름):

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

구성:

(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

관리 경로:

INTRAVENOUS

치료 징후:

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 its excipients (sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20). 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 pregnanci

제품 요약:

How Supplied ELOCTATE is supplied in kits comprising a single-dose 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. Not made with natural rubber latex. Storage and Handling Prior to reconstitution: After Reconstitution:

승인 상태:

Biologic Licensing Application

제품 특성 요약

ELOCTATE- ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN
BIOVERATIV THERAPEUTICS 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
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: nominally 250, 500, 750, 1000, 1500, 2000, 3