FDA approves Xarelto to help prevent DVT in patients undergoing knee- or hip-replacement surgery

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.

“We believe Xarelto will be a positive formulary addition,” Shaun Mickus, Janssen Pharmaceuticals’ director of product communication for Xarelto, told Formulary, Drug Topics’ sister publication. “Xarelto demonstrated enhanced patient protection versus enoxaparin, with comparable safety in patients undergoing knee- or hip-replacement surgery, and expands the therapeutic options available to orthopedic surgeons.

“With its once-daily oral dosing, Xarelto may help patients at risk of thrombotic events after these surgeries to more easily maintain therapy, including while transitioning between sites of care. Additionally, Xarelto eliminates the need for self-injections and for routine monitoring of INR counts or other coagulation parameters,” Mickus added.

The distributor list price is $6.75/day.

According to the American Academy of Orthopedic Surgeons, more than 800,000 Americans undergo knee-or hip-replacement surgery each year. These procedures are associated with increased risk of DVT. If all or part of a DVT breaks off, it can travel to the lungs and become a PE, where it may impact the flow of oxygenated blood and lead to potentially life-threatening consequences.

The American College of Chest Physicians recommends immediate use of anticoagulants after major orthopedic replacement surgery and extended use post-discharge (at least 10 days for knee replacement and up to 35 days for hip replacement) to help reduce such risks; however, full compliance with these guidelines using previously available options has not been widely observed. DVT and PE are the leading causes of re-hospitalization following joint replacement surgery.

Pivotal data from the Xarelto phase 3 clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin, followed by placebo. In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles, including low rates of major bleeding.

Xarelto is approved for use at a 10-mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery. It is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.

Xarelto can cause bleeding, which can sometimes be serious, evenlife-threatening. Patients may find they bruise or bleed more easily while they take it. It might take longer than usual to stop bleeding. Patients should alert their doctor immediately if they develop any of the following symptoms:

• Tingling, numbness, or muscle weakness, especially in the legs. This is particularly important if a spinal or epidural puncture was part of the anesthesia during the hip- or knee-replacement surgery.
• Unusual bleeding or bruising (bruises that develop without an injury or grow in size)
• New bleeding (for example, nosebleeds, bleeding gums, red urine, bright red blood in the stool, coughing up or vomiting blood)
• Bleeding that is heavier than usual (for example, from cuts or menstruation)
• Dizziness, weakness, or fatigue, all of which could indicate a loss of blood