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Mononine

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Mononine

Mononine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mononine (coagulation factor IX human) is a clotting factor used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency. This medication is available in generic form. Common side effects include headache; warmth or tingly feeling under your skin; nausea, vomiting; dizziness; or pain, redness, or swelling where the medicine was injected.

The dose of Mononine to be infused, as well as the frequency of infusions, will vary with each patient and with the clinical situation. Mononine may interact with other drugs. Tell your doctor all medications and supplements you use. Mononine may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Mononine (coagulation factor IX human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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:

  • headache;
  • 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
(Adverse Reactions)

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.

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® (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)) »

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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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