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Mononine Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Mononine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- fever or chills;
- continued bleeding after treatment;
- feeling like you might pass out;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance; or
- swelling in your feet or ankles, weight gain, loss of appetite.
Less serious side effects may be more likely to occur, such as:
- warmth, redness, or tingly feeling under your skin;
- nausea, vomiting;
- dizziness; or
- pain, redness, or swelling where the medicine was injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Mononine (Coagulation Factor IX (Human)) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mononine FDA Prescribing Information: Side Effects
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® (coagulation factor ix (human)) in previously untreated hemophilia Bpatients, five patients experienced ALTelevations. 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® (coagulation factor ix (human)) as well as other Factor IX products:anaphylaxis, angioedema, cyanosis, dyspnea, hypotension, thrombosis, inadequate therapeutic response, and inhibitor development.
The patient should be monitored closely during the infusion of Mononine® (coagulation factor ix (human)) to observe for the development of any reaction. If any reaction takes place that is thought to be related to the administration of Mononine® (coagulation factor ix (human)) , 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.
Read the entire FDA prescribing information for Mononine (Coagulation Factor IX (Human)) »
Additional Mononine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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