COAGULATION FACTOR IX

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%

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Formulations

Dosage Forms

Tablet

Route

Oral