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 and supportive therapy should be administered.
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REPORTS OF SUSPECTED MONONINE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Mononine. The information is not vetted and should not be considered as verified clinical evidence.
Possible Mononine side effects / adverse reactions in 65 year old male
Reported by a physician from United States on 2012-08-24
Patient: 65 year old male weighing 133.0 kg (292.6 pounds)
Reactions: Epistaxis
Suspect drug(s):
Benefix
Dosage: 3000 iu, 2x/day
Indication: Factor IX Deficiency
Mononine
Dosage: unk
Indication: Factor IX Deficiency
End date: 2010-01-01
Benefix
Dosage: 6000 iu, 2x/day (3 days)
Start date: 2010-01-01
Benefix
Dosage: 3000 iu, 2x/day
Start date: 2010-01-01
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