on the severity of the reaction, if these symptoms occur.
Some viruses such as hepatitis A are particularly difficult to remove or inactivate at this time. Although the overwhelming number of hepatitis A cases are community acquired, there have been reports of these infections associated with the use of some plasma-derived products. Therefore, physicians should be alert to the potential symptoms of hepatitis A infections and inform patients under their supervision receiving plasma-derived products to report potential symptoms promptly.
Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physicians if such symptoms occur.
Pregnancy Category C
Animal reproduction studies have not been conducted with Mononine®. It is also not known whether Mononine® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mononine® should be given to a pregnant woman only if clearly needed.
Pediatric Use
eva luation of the safety and effectiveness of Mononine® treatment in 51 pediatric patients between the ages of 1 day and 20 years, as a part of virus safety trials and trials for surgery, trauma or spontaneous bleeding, showed that excellent hemostasis was achieved with no thrombotic complications.10 Included in the experience with patients aged birth to 20 years are two long-term virus safety studies demonstrating lack of virus transmission. Dosing in children is based on body weight and is generally based on the same guidelines as for adults (see DOSAGE AND ADMINISTRATION).
Geriatric Use
Clinical studies of Mononine® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.
ADVERSE REACTIONS
As with the intravenous administration of other plasma-derived products, the following reactions may be observed following administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, stinging or burning at the infusion site or manifestations of allergic reactions. In a clinical study with Mononine® in previously untreated hemophilia B patients, five patients experienced ALT elevations. Serologic tests for hepatitis A, hepatitis B, hepatitis C, Cytomegalovirus, and Epstein-Barr virus were negative.
The following adverse reactions have been spontaneously reported during post-marketing use of Mononine® as well as other Factor IX products: anaphylaxis, angioedema, cyanosis, dyspnea, hypotension, thrombosis, inadequate therapeutic response, and inhibitor development.
There is a potential risk of thromboembolic episodes following the administration of Mononine® (see WARNINGS and PRECAUTIONS).
The patient should be monitored closely during the infusion of Mononine® to observe for the development of any reaction. 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.
Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate countermeasures |
