Indications and clinical use

• Jivi (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) is indicated in previously treated adults and adolescents (≥12 years of age) with hemophilia A (congenital Factor VIII deficiency) for:
  • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
  • Control and prevention of episodic bleeding
  • Peri-operative management of bleeding (surgical prophylaxis)
• Jivi does not contain von Willebrand factor and is not indicated for the treatment of von Willebrand disease
• Safety and efficacy for previously untreated patients (PUPs) have not been studied
• Safety and efficacy of Jivi has not been established in pediatric patients <12 years of age. Jivi is not indicated for use in children <12 years of age due to a greater risk for hypersensitivity reactions.
• Geriatric patients: Clinical studies of Jivi did not include subjects aged 65 and over. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Contraindications

• Patients who have had prior anaphylactic reaction to this drug or its components, or to mouse or hamster protein

Relevant warnings and precautions

• Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis
• Consider risk of central venous access device (CVAD)-related complications if a CVAD is required
• Hypersensitivity reactions, including anaphylaxis
• Immune response associated with anti-polyethylene glycol (PEG)
• Monitor plasma Factor VIII activity and for the formation of neutralizing antibodies (inhibitors) to Factor VIII
• Pregnant women: Jivi should be used during pregnancy only if the potential benefit justifies the potential risk
• Nursing women: Factor VIII should be used during lactation only if clearly indicated

For more information
Please consult the Product Monograph at https://www.bayer.com/sites/default/files/2020-11/Jivi-pm-en.pdf for important information relating to adverse reactions and dosing information, which have not been discussed in this piece.

The Product Monograph is also available by calling 1-800-265-7382.¹