ESPEROCT (antihemophilic factor- recombinant, glycopegylated-exei kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Novo Nordisk

Anwendungsgebiete:

ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: Limitation of Use: ESPEROCT is not indicated for the treatment of von Willebrand disease. (1) ESPEROCT is contraindicated in patients who have known hypersensitivity to ESPEROCT or its components (including hamster proteins) [see Warnings and Precautions (5.1) and Description (11) ]. There are no data with ESPEROCT use in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with ESPEROCT. It is unknown whether ESPEROCT can cause fetal harm when administered to a pregnant woman or can affect fertility. 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 information regarding the presence of ESPEROCT in human

Produktbesonderheiten:

How Supplied Table 9: ESPEROCT Presentations 500 IU Red NDC 0169 8500 01 1000 IU Green NDC 0169 8100 01 1500 IU Gray NDC 0169 8150 01 2000 IU Yellow NDC 0169 8200 01 3000 IU Black NDC 0169 8300 01 IU = International Units Storage and Handling

Berechtigungsstatus:

Biologic Licensing Application

Fachinformation

ESPEROCT- ANTIHEMOPHILIC FACTOR (RECOMBINANT), GLYCOPEGYLATED-EXEI
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESPEROCT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESPEROCT.
ESPEROCT [ANTIHEMOPHILIC FACTOR (RECOMBINANT),
GLYCOPEGYLATED-EXEI]
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is
a coagulation Factor VIII
concentrate indicated for use in adults and children with hemophilia A
for:
•
•
•
ESPEROCT is not indicated for the treatment of von Willebrand disease.
(1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INFUSION AFTER RECONSTITUTION ONLY.
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
ESPEROCT is available as a lyophilized powder in single-dose vials of
dosage strengths at 500, 1000, 1500,
2000 and 3000 IU per vial. (3)
CONTRAINDICATIONS
Do not use in patients who have known hypersensitivity to ESPEROCT or
its components, including
hamster proteins. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1%) were rash,
redness, itching and injection site
reactions. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVO NORDISK INC. AT
1-800-727-6500 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
®
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes (1)
Each vial label for ESPEROCT states the actual Factor VIII activity in
international units (IU). (2.1)
On-demand treatment/control of bleeding episodes: In adolescents /
adults, 40 IU/kg body weight for
minor/moderate bleeds and 50 IU/kg body weight for major bleeds;
children (<12 years), 65 IU/kg
body weight for minor/moderate/major bleeds. (2.1)
Perioperative management: For minor/major surgery: In adolescents /
adults: pre-operative dose of
50