ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein]
Lyophilized Powder for Solution For Intravenous Injection.
Table 3: Adverse Reactions Reported for ELOCTATE (N=164)
MedDRA System Organ Class
MedDRA Preferred Term
Brief Summary of Full Prescribing Information.
1 INDICATIONS AND USAGE
ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant
DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A
(congenital Factor VIII deficiency) for:
• Control and prevention of bleeding episodes,
• Perioperative management (surgical prophylaxis),
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ELOCTATE is not indicated for the treatment of von Willebrand disease.
4 CONTRAINDICATIONS
ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity
reactions to ELOCTATE, including anaphylaxis.
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Early signs
of hypersensitivity reactions that can progress to anaphylaxis may include angioedema,
chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue
administration and initiate appropriate treatment if hypersensitivity reactions occur.
5.2 Neutralizing Antibodies
Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following
administration of ELOCTATE. Monitor all patients for the development of Factor VIII
inhibitors by appropriate clinical observations and laboratory tests. If the plasma
Factor VIII level fails to increase as expected or if bleeding is not controlled after
ELOCTATE administration, suspect the presence of an inhibitor (neutralizing antibody).
[see Monitoring Laboratory Tests (5.3)]
5.3 Monitoring Laboratory Tests
• Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage
clotting assay), to confirm that adequate Factor VIII levels have been achieved and
maintained. [see Dosage and Administration (2)]
• Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor
assay if expected Factor VIII plasma levels are not attained, or if bleeding is not
controlled with the expected dose of ELOCTATE. Use Bethesda Units (BU) to report
inhibitor levels.
6 ADVERSE REACT SӔ