BeneFIX Adverse Reactions

The table as follows lists adverse reactions reported in the clinical trials of previously treated patients and previously untreated patients and identified in post-marketing use. The frequencies are based on all causality treatment emergent events in pooled clinical trials with 287 subjects. (See Table 4.)

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If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX, see Dosage & Administration and Precautions.
Inhibitor development: Patients with hemophilia B may develop neutralizing antibodies (inhibitors).
A clinically relevant, low-responding transient inhibitor (maximum titer 1.5 BU) was detected in 1 out of 65 BeneFIX patients (including 9 patients participating only in the surgery study) who had previously received plasma-derived products (PTPs). This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis.
From results of the PUP study, 2/63 patients developed inhibitors after 7 and 15 exposure days. Both were high-titer inhibitors. Both patients experienced allergic manifestations in temporal association with their inhibitor development.