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August 25, 2021August 24, 2021 – Xarelto® (rivaroxaban) is now approved for use with aspirin to reduce the risk of sudden decrease in blood flow to the legs, major amputation, serious heart problems, or stroke in individuals who have peripheral artery disease (PAD) and have had recent lower-extremity revascularization (surgical restoration of blood flow) due to symptomatic PAD.
- This is an expansion of an already approved indication for the drug.
- In addition to the indication for PAD, Xarelto is also FDA approved to reduce the risk of blood clots, serious heart problems, heart attack, and/or stroke in individuals who meet a variety of criteria such as (but not limited to) a diagnosis of atrial fibrillation, recent surgery for hip replacement, presence of coronary artery disease, or a diagnosis of deep vein thrombosis or pulmonary embolism.
- The recommended dosing for treatment of PAD is 2.5mg of Xarelto twice daily plus aspirin (75- 100mg) once daily. Xarelto, manufactured by Janssen, is an oral tablet that can be taken with or without food.
- Xarelto first received FDA approval in 2011.