The active ingredient in ANDEXXA is a genetically modified variant of human Factor Xa. After reconstitution of the lyophilized powder with sterile Water for Injection for intravenous (IV) administration, the product is a clear, colorless to slightly yellow solution. DESCRIPTIONĪNDEXXA ( coagulation factor Xa ( recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials, containing 100 mg of coagulation factor Xa formulated with the inactive ingredients tromethamine (Tris), L-arginine hydrochloride, sucrose (2% w/v), mannitol (5% w/v), and polysorbate 80 (0.01% w/v) at pH 7.8. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. Monitor for thromboembolic events and initiate anticoagulation when medically appropriate.

Ischemic events, including myocardial infarction and ischemic stroke.

Arterial and venous thromboembolic events.

Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: (WARNINGS AND PRECAUTIONS) THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS

You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of AndexXa. Tell the doctor if you have any side effect that bothers you or that does not go away.

pain, swelling, burning, or irritation around the IV needle.

The most common side effects of AndexXa include: Get medical help right away, if you have any of the symptoms listed above.

pain spreading to your jaw or shoulder,.

swelling of your face, lips, tongue, or throat,.

What are the possible side effects of AndexXa?ĪndexXa may cause serious side effects including: It is not known if AndexXa is safe and effective in children. AndexXa may be used alone or with other medications.ĪndexXa belongs to a class of drugs called Factor Xa Inhibitor Antidotes. AndexXa is a prescription medicine used to treat symptoms of Factor Xa Reversal.

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