e hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in Hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to factor IX. The safety and efficacy of using Mononine® in attempted immune tolerance induction has not been established.
PRECAUTIONS
Extensive clinical experience suggests that there is a lower risk of thromboembolic complications with the use of Mononine® than with prothrombin complex concentrates. However, as with all products containing Factor IX, caution should be exercised when administering Mononine® to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or DIC.8,9 In each of these situations, the potential benefit of treatment with Mononine® should be weighed against the potential risk of these complications.
Mononine® should be administered intravenously at a rate that will permit observation of the patient for any immediate reaction. Rates of infusion of up to 225 IU per minute have been regularly tolerated with no adverse reactions. If any reaction takes place that is thought to be related to the administration of Mononine®, the rate of infusion should be decreased or the infusion stopped, as dictated by the response of the patient. The infusion should be stopped promptly and appropriate countermeasures and supportive therapy should be administered should evidence of an acute hypersensitivity reaction be observed. Patients known to have major deletion mutations of the factor IX gene may be at increased risk for inhibitor formation and acute hypersensitivity reactions. (See WARNINGS.)
During the course of treatment, determination of daily Factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to Mononine®, achieving different levels of in vivo recovery and demonstrating different half-lives.
The use of high doses of Factor IX Complex concentrates has been reported to be associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. Generally a Factor IX level of 25-50% [IU/dL] is considered adequate for hemostasis, including major hemorrhages and surgery. Attempting to maintain Factor IX levels of >75-100% [IU/dL] during treatment is not routinely recommended nor required. To achieve Factor IX levels that will remain above 25% [IU/dL] between once a day administrations, each daily dose should attempt to raise the 30-minute post-infusion Factor IX level to 50-60% [IU/dL] (see DOSAGE AND ADMINISTRATION).
No controlled studies have been available regarding the use of ε-amino caproic acid or other antifibrinolytic agents following an initial infusion of Mononine® for the prevention or treatment of oral bleeding following trauma or dental procedures such as extractions.
Information For Patients
Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending |
