During the clinical studies conducted in the previously treated patient group, there were 13 infusion related minor adverse reactions reported out of 13,394 infusions (0.097%). One patient experienced flushing and nausea during his first infusion which abated on decreasing the infusion rate. A second patient experienced mild fatigue during and following one infusion and the third patient had a series of eleven nose bleeds with a periodicity associated with the infusions.
The protein in greatest concentration in Antihemophilic Factor (Recombinant) Bioclate (antihemophilic factor) is Albumin (Human). Reactions associated with intravenous administration of albumin are extremely rare, although nausea, fever, chills or urticaria have been reported. Other allergic reactions could theoretically be encountered in the use of this Antihemophilic Factor preparation. See PATIENT INFORMATION.