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FDA approves 30-day pack of anticoagulant


 

Thrombus

Credit: NHS

The US Food and Drug Administration (FDA) has approved the Xarelto Starter Pack™ for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

The pack provides a 30-day supply of Xarelto (rivaroxaban), which gives patients time to follow up with their primary care physician after leaving the hospital, without missing treatment.

Patients have the greatest risk of recurrence in the first 30 days after a DVT or PE.

“The starter pack will make a difference for patients impacted by blood clots by offering a 30-day supply of the drug in a new, convenient package, which may help support patients as they transition from the hospital to outpatient care,” said Paul Burton, MD, PhD, Vice President of Medical Affairs at Janssen, the company developing Xarelto.

The Xarelto Starter Pack™ will be available at pharmacies in October.

Xarelto is a factor Xa inhibitor that is FDA-approved to treat and prevent the recurrence of DVT/PE, as thromboprophylaxis in patients who have undergone knee or hip replacement surgery, and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

For DVT/PE patients, Xarelto is given twice daily at 15 mg with food for the first 21 days. On day 22, patients transition to a once-daily dose of 20 mg with food for the remainder of treatment.

Xarelto has a boxed warning stating that premature discontinuation of the drug increases the risk of thrombotic events, and epidural or spinal hematomas have occurred in Xarelto-treated patients who are receiving neuraxial anesthesia or undergoing spinal puncture.

For more details on Xarelto, see the full prescribing information.

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