title: Possible Rivaroxaban Failure during the Postpartum Period.
abstract: Rivaroxaban, a factor Xa inhibitor, is a direct-acting oral anticoagulant (DOAC) indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of DVT and PE recurrence. To our knowledge, no data are presently available to guide DOAC dosing in the postpartum period when pharmacokinetic and pharmacodynamic changes induced by pregnancy have an impact on drug clearance and increase hypercoagulability for a period of 6-8 weeks after delivery. We describe the case of a 35-year-old postpartum woman who presented to the emergency department with a diagnosis of a new multiple segmental PE 5 days after starting rivaroxaban therapy for a diagnosis of DVT. No precipitating cause, including noncompliance, was identified as a source of thrombosis embolization or extension. The patient was admitted, a heparin infusion was started for the management of PE, and rivaroxaban was discontinued. She was transitioned to enoxaparin 1 mg/kg (90 mg) subcutaneously every 12 hours the next day, bridged to warfarin, and discharged home on the overlapping regimen with close follow-up by the pharmacist-managed outpatient Anticoagulation Management Service. To our knowledge, this is the first case report of potential failure associated with rivaroxaban therapy in the postpartum period, possibly due to pharmacokinetic alterations seen in the postpartum period contributing to decreased drug exposure, yielding reduced anticoagulant efficacy. Clinicians should carefully weigh the risks and benefits of DOAC therapy in postpartum patients or other special populations requiring anticoagulation therapy. This report also highlights the need for further research identifying the impact of pharmacokinetic changes induced by special populations and the need to develop monitoring assays for such clinical situations.
authors.affiliation: Section of Clinical Pharmacy, Department of Pharmaceutical Care Services, Bassett Medical Center, Cooperstown, New York.
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Rudd
authors.affiliation: Section of Clinical Pharmacy, Department of Pharmaceutical Care Services, Bassett Medical Center, Cooperstown, New York.
authors.forename: Amanda R McFee
authors.initials: AR
authors.lastname: Winans
authors.affiliation: Department of Medical Education, Bassett Medical Center, Cooperstown, New York.
authors.forename: Narmadha
authors.initials: N
authors.lastname: Panneerselvam
mesh_terms: D000284:Administration, Oral; D000328:Adult; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D049590:Postpartum Period; D011655:Pulmonary Embolism / Q000188:drug therapy*; D012008:Recurrence; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
keywords: anticoagulation; direct-acting oral anticoagulant; pharmacokinetics; postpartum; pregnancy