The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.
Postpartum within 6 weeks of delivery
Greater than 18 years old at expected date of delivery
English speaking
Hemodynamically stable without concern for ongoing blood loss
Pregnant
Less than 18 years old at estimated date of delivery
Hemodynamic instability and/or concern for ongoing blood loss
Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period
Parallel
Rivaroxaban 10 MG Oral Tablet
Drug10mg rivaroxaban daily
Rivaroxaban 20 MG Oral Tablet
Drug20mg rivaroxaban daily
Concentration of rivaroxaban in breast milk
Time/Concentration profile of rivaroxaban in breast milk prior to intake (0) and 3, 6, 12, 15 and 24 hours following morning dose on day 0-1
Concentration of rivaroxaban in breast milk
Time/concentration profile of rivaroxaban in breast milk 3 hours following morning dose on day 2 and onward
Absolute infant dose of rivaroxaban
The absolute infant dose is calculated from average drug concentrations in breast milk multiplied by an estimated breast milk intake of 150 mL/kg/day.
Relative infant dose
The relative infant dose is the absolute infant dose expressed as a percentage of the weight adjusted maternal dose, based on an average maternal weight of 75 kg. It is expressed in mg/kg/day.
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