Click on icon to see table/diagram/image
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.
View ADR Monitoring Form