NEODOSE

FDA APPROVED INDICATION

• Routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients with hereditary factor X deficiency.
• On-demand control and treatment of bleeding episodes in pediatric patients with hereditary factor X deficiency.
• Perioperative management of bleeding in pediatric patients with mild to moderate hereditary factor X deficiency. Use of factor X human for perioperative management of bleeding with major surgery in patients with severe hereditary factor X deficiency has not been studied.

PRECAUTIONS

• Allergic hypersensitivity reactions:
  • may occur, including anaphylaxis.
• Immunologic:
  • Factor X human neutralizing antibodies or inhibitors may develop.
• Infections:
  • Infectious agent transmission may occur, including a risk of exposure to viruses, Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease, and other pathogens.

ADVERSE EFFECTS

During clinical trials, adverse reactions were reported in 2 out of 18 patients. The reported adverse effects were infusion site erythema (5.6%), fatigue (5.6%), back pain (5.6%), and infusion site pain (5.6%).

ADMINISTRATION

Administer by IV infusion at a rate of 10 mL/min; MAX rate 20 mL/min. After dilution, the final concentration is approximately 100 international units/mL.

MONITORING

• Monitor plasma factor X activity and confirm adequate levels have been achieved and maintained by performing a validated test (eg, one-stage clotting assay).
• For perioperative use, measure post-infusion factor X activity before and after surgery.
• For prophylaxis of bleeding episodes, trough blood levels of Factor X should be monitored at intervals, especially in the first weeks of therapy or after dosages changes.
• Monitor for development of neutralizing antibodies (inhibitors). If expected activity levels are not attained or if bleeding is not controlled with an appropriate dose, perform an assay measuring inhibitor concentration (Nijmegen-Bethesda inhibitor assay).