Discontinue use if symptoms of hypersensitivity occur. Increased risk of anaphylaxis w/ subsequent challenge w/ factor IX in patients w/ factor IX inhibitors. Nephrotic syndrome following attempted immune tolerance induction in haemophilia B patients w/ factor IX inhibitors & history of allergic reaction. Patients w/ signs of fibrinolysis & w/ disseminated intravascular coagulation (DIC); existing CV risk factors. Carefully monitor patients for development of factor IX inhibitors. Evaluate patients experiencing allergic reactions for presence of inhibitor. Closely observe patients known to have major deletion mutations of factor IX gene for signs & symptoms of acute hypersensitivity reactions, particularly during early phases of initial exposure. Perform clinical surveillance for early signs of thrombotic & consumptive coagulopathy in patients w/ liver disease, to patients post-op, newborn infants, or at risk of thrombotic phenomena or DIC. Pregnancy & lactation. Critically ill neonates (thrombotic events, including superior vena cava syndrome while receiving continuous infusion through central venous catheter).
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