Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

Novoeight is an Antihemophilic Factor (Recombinant) indicated for use in adults and children with hemophilia A for:
• Control and prevention of bleeding
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Novoeight is not indicated for the treatment of von Willebrand disease. (1)

Full Prescribing information

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Oral Anticoagulation Reversal

Experts discuss the use of non-vitamin K oral anticoagulants in the treatment and prevention of stroke, deep vein thrombosis and pulmonary embolism in atrial fibrillation patients

Visit Oral Anticoagulation Reversal


Cystic Fibrosis

View disease awareness information, treatment options and European Cystic Fibrosis Society best practice guidelines

Visit Cystic Fibrosis


Related Content

Advisory information

contraindications

Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight or its components, including hamster proteins. (4)

Special warnings and precautions

• Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight and administer appropriate treatment. (5.1)
• Development of activity-neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. (5.2, 5.3)

Adverse reactions

• The most frequently reported adverse reactions (≥ 0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia. (6)

Usage information

Dosing and administration

For intravenous injection after reconstitution only (2)
• 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 recommendation of the treating physician (2.1)

Use in special populations
• Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
• Pediatric Use: Clearance (based on per kg body weight) is higher in children. Higher or more frequent dosing may be needed. (8.4)

More information

Category Value
Authorisation number BLA125466
Orphan designation No
Product NDC 0169-7810; 0169-7815; 0169-7820; 0169-7825; 0169-7830; 0169-7850
Date First Approved 01-04-2015
Marketing authorisation holder Novo Nordisk