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Matched label
ELIQUIS
APIXABAN - REMEDYREPACK INC.
is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
Label facts
- Application
- NDA202155
- Route
- ORAL
- Label updated
- August 29, 2025
Indication
is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery.
Dose and administration
Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation: The recommended dose is 5 mg orally twice daily. In patients with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1. 5 mg/dL, the recommended dose is 2.
Side effects
- related to bleeding
Safety flags
Prosthetic heart valves
Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome
Contraindication: the following conditions: Active pathological bleeding Severe hypersensitivity reaction to ELIQUIS (e
Source links
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