What is COAGULATION FACTOR IX used for?

COAGULATION FACTOR IX (brand name Ixinity) is a Other indicated for 1 INDICATIONS AND USAGE IXINITY, Coagulation Factor IX (Recombinant), Coagulation Factor IX (Recombinant).

What are the most common side effects of COAGULATION FACTOR IX?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for COAGULATION FACTOR IX. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is COAGULATION FACTOR IX the same as Ixinity?

Ixinity is a brand name for COAGULATION FACTOR IX. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

COAGULATION FACTOR IX

Q: How does COAGULATION FACTOR IX work?

COAGULATION FACTOR IX works through the following mechanism: 12.1 Mechanism of Action Hemophilia B is a sex-linked hereditary disorder of blood coagulation caused by a deficiency in factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Treatment with IXINITY replaces factor IX, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies..

Other

Brand names: Ixinity

Oral

Mechanism of Action

12.1 Mechanism of Action Hemophilia B is a sex-linked hereditary disorder of blood coagulation caused by a deficiency in factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. Treatment with IXINITY replaces factor IX, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.

Indications

1 INDICATIONS AND USAGE IXINITY

Coagulation Factor IX (Recombinant)

Contraindications

• 4 CONTRAINDICATIONS IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients
• including hamster protein [see Warnings and Precautions (5.1) ]. Do not use in patients with known hypersensitivity to IXINITY or its excipients
• including hamster protein ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis has occurred
If expected factor IX activity plasma levels are not attained, or if bleeding is not controlled as expected with the calculated dose, perform an assay that measures factor IX inhibitor concentration [see Warnings and Precautions (5
Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to IXINITY
Because of the potential risk for thromboembolism with the use of factor IX products, monitor for early signs of thromboembolism and consumptive coagulopathy when administering IXINITY to patients with liver disease, fibrinolysis, peri-operative status, or risk for thromboembolic events or disseminated intravascular coagulation

Known Side Effects

5 documented side effects by frequency

Drug Not Working

>10%

Joint Pain

1-10%

Headache

1-10%

Dizziness

0.1-1%

Nausea

0.1-1%

Community Discussions

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Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → COAGULATION FACTOR IX openFDA label JSON → COAGULATION FACTOR IX FAERS adverse-event reports → COAGULATION FACTOR IX ClinicalTrials.gov → completed Phase 2+ trials of COAGULATION FACTOR IX

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Formulations

Dosage Forms

Tablet

Route

Oral