NOVOEIGHT (- antihemophilic factor, recombinant kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novo Nordisk

INN (International Name):

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Composition:

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 62.5 [iU] in 1 mL

Therapeutic indications:

Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: Novoeight is not indicated for the treatment of von Willebrand disease. Novoeight is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight or its components (including traces of hamster proteins). Risk Summary As hemophilia mainly affects males, there are no adequate and well-controlled studies using Novoeight in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with Novoeight. 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. There is no reliable data on the incidences specific to the hemophilia A population. Risk Summary There is no information regarding the prese

Product summary:

How Supplied Presentation (Nominal Product Strength) Carton NDC Number Components 250 International Units NDC 0169 7825 01 500 International Units NDC 0169 7850 01 1000 International Units NDC 0169 7810 01 1500 International Units NDC 0169 7815 01 2000 International Units NDC 0169 7820 01 3000 International Units NDC 0169 7830 01 Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVOEIGHT- (ANTIHEMOPHILIC FACTOR, RECOMBINANT)
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOEIGHT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NOVOEIGHT.
NOVOEIGHT (ANTIHEMOPHILIC FACTOR, RECOMBINANT)
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Novoeight is an Antihemophilic Factor (Recombinant) indicated for use
in adults and children with hemophilia A for:
•
•
•
Novoeight is not indicated for the treatment of von Willebrand
disease. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INJECTION AFTER RECONSTITUTION ONLY (2)
•
•
•
DOSAGE FORMS AND STRENGTHS
Novoeight is available as a lyophilized powder in single-dose vials of
250, 500, 1000, 1500, 2000 and 3000 international
units. (3)
CONTRAINDICATIONS
Do not use in patients who have had life-threatening hypersensitivity
reactions, including anaphylaxis, to Novoeight or its
components, including hamster proteins. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 1%) were
inhibitors in Previously Untreated Patients (PUPs), injection
site reactions, and pyrexia. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVO NORDISK INC. AT
1-844-303-4448 OR FDA AT 1-800-
FDA-1088 OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2020
On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes.
Each vial of Novoeight contains the labeled amount of recombinant
Factor VIII in international units (IU). (2)
The required dosage is determined using the following formula:
Dosage Required (IU) = Body Weight (kg) × Desired Factor VIII
Increase (IU/dL or % normal) × 0.5 (IU/kg per
IU/dL)
Frequency of Novoeight administration is determined by the type of
bleeding episode and the