title: The Direct Factor Xa Inhibitor Rivaroxaban Passes Into Human Breast Milk.
abstract: Thromboembolic disorders frequently require antithrombotic treatment during pregnancy and lactation. Vitamin K antagonists and heparins are the treatment options of choice in breastfeeding women. Factors including the route of administration, discomfort during treatment, and fetal and neonatal safety affect women's choices about anticoagulant therapy. Direct-acting oral anticoagulants (DOACs) have emerged as alternatives to these agents and may offer advantages compared with vitamin K antagonists. As breastfeeding women were excluded from clinical trials evaluating DOACs, no safety and efficacy data are available for these special patients and, crucially, estimates for infant exposure are lacking. Therefore, the manufacturer recommends against using DOACs during the lactation period. We present the case of a patient who stopped breastfeeding owing to a diagnosis of postpartum cardiomyopathy. Anticoagulation with enoxaparin that commenced after the diagnosis of postpartum pulmonary embolism was switched to rivaroxaban. At that time, breast milk samples were collected and rivaroxaban concentrations were determined by liquid chromatography tandem-mass spectrometry. Rivaroxaban appears in human breast milk in comparatively small amounts; its safety has not been determined.
authors.affiliation: Centre of Pharmacology, Department of Therapeutic Drug Monitoring, University Hospital of Cologne, Cologne, Germany. Electronic address: martin.wiesen@uk-koeln.de.
authors.forename: Martin H J
authors.initials: MH
authors.lastname: Wiesen
authors.affiliation: Centre of Pharmacology, Department of Therapeutic Drug Monitoring, University Hospital of Cologne, Cologne, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Blaich
authors.affiliation: Centre of Pharmacology, Department of Therapeutic Drug Monitoring, University Hospital of Cologne, Cologne, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Müller
authors.affiliation: Department of Clinical Chemistry, University Hospital of Cologne, Cologne, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Streichert
authors.affiliation: Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.
authors.forename: Roman
authors.initials: R
authors.lastname: Pfister
authors.affiliation: Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.
authors.forename: Guido
authors.initials: G
authors.lastname: Michels
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D001942:Breast Feeding; D002845:Chromatography / Q000379:methods; D000072226:Computed Tomography Angiography / Q000379:methods; D016903:Drug Monitoring / Q000379:methods; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D008168:Lung / Q000000981:diagnostic imaging; D019028:Magnetic Resonance Imaging, Cine / Q000379:methods; D008895:Milk, Human / Q000737:chemistry / Q000378:metabolism; D011247:Pregnancy; D011644:Puerperal Disorders / Q000175:diagnosis / Q000188:drug therapy; D011655:Pulmonary Embolism / Q000175:diagnosis / Q000188:drug therapy; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000493:pharmacokinetics; D016896:Treatment Outcome
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
keywords: breastfeeding; lactation; liquid chromatography tandem-mass spectrometry; pulmonary embolism; rivaroxaban