利伐沙班获批适应症

Rivaroxaban is a new type of oral anticoagulant with high bioavailability, long action window, safe and effective. Rivaroxaban tablets were approved for marketing by the State Food and Drug Administration in March 2009. What are the approved indications for rivaroxaban?

Rivaroxaban approved indications:

1. For use in adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE).

2. Used to treat venous thrombosis (DVT) in adults and reduce the risk of DVT recurrence and pulmonary embolism (PE) after acute DVT.

3. For use in adult patients with nonvalvular atrial fibrillation who have one or more risk factors (e.g., congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack) to reduce the risk of stroke and systemic embolism.

Rivaroxaban is contraindicated in the following patients:

1. Patients who are allergic to rivaroxaban or any excipients in the tablets.

2. Patients with clinically obvious active bleeding.

3. Lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injury, recent brain, spine or eye surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intravertebral intracranial vascular malformations.

4. Except in the case of switching to or from rivaroxaban from other treatments, or the administration of unfractionated heparin (UFH) doses required to maintain central venous or arterial catheters, concomitant treatment with any other anticoagulants is prohibited, such as UFH, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.).

5. Patients with liver disease associated with coagulation abnormalities and clinically relevant bleeding risks, including patients with cirrhosis reaching Child Pugh classes B and C.