BeneFIX Special Precautions

Hypersensitivity: Allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products, including BeneFIX. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions, including hives, generalized urticaria, chills (rigors), flushing, angioedema, chest tightness, laryngospasm, bronchospasm, dyspnea, wheezing, faintness, hypotension, tachycardia, blurred vision, and anaphylaxis. If allergic or anaphylactic reactions occur, administration of BeneFIX should be stopped immediately, and appropriate medical management should be given, which may include treatment for shock. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur.
Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. The safety and efficacy of using BeneFIX for immune tolerance induction have not been established.
In case of severe allergic reactions, alternative hemostatic measures should be considered.
Activity-neutralizing antibodies (inhibitors): Inhibitors have been detected in patients receiving factor IX-containing products. As with all factor IX products, patients using BeneFIX should be monitored for the development of factor IX inhibitors. Patients with factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with factor IX. Patients experiencing allergic reactions should be evaluated for the presence of inhibitor. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. In view of the potential for allergic reactions with factor IX concentrates, the initial administrations (approximately 10-20) of factor IX should be performed under medical supervision where proper medical care for allergic reactions could be provided.
Thrombosis: Historically, the administration of factor IX complex concentrates derived from human plasma, containing factors II, VII, IX and X has been associated with the development of thromboembolic complications. Although BeneFIX contains no coagulation factor other than factor IX, the potential risk of thrombosis and disseminated intravascular coagulation (DIC) observed with other products containing factor IX should be recognized. Because of the potential risk of thromboembolic complications, caution should be exercised when administering this product to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or DIC.
The safety and efficacy of BeneFIX administration by continuous infusion have not been established. See Dosage & Administration and Adverse Reactions. There have been post-marketing reports of thrombotic events, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter.
In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications.
Effects on ability to drive and use machines: On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions BeneFIX has no or negligible influence on the ability to drive or use machines.