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Contraindicated in patients with hypersensitivity to rivaroxaban or any component of the formulation.
Contraindicated in patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding).
Contraindicated in patients with hepatic disease which is associated with coagulopathy leading to clinically relevant bleeding risk.
Safety and efficacy of rivaroxaban have not been established in pregnant women. Animal data show that rivaroxaban crosses the placental barrier. Therefore use of rivaroxaban is contraindicated throughout pregnancy.
Safety and efficacy of rivaroxaban have not been established in nursing mothers. Animal data indicate that rivaroxaban is secreted into breast milk. Therefore rivaroxaban may only be administered after breastfeeding is discontinued.
