T:10.5 in S:9.5 in
IMPORTANT SAFETY INFORMATION (cont’d)
USE IN SPECIFIC POPULATIONS (cont’d)
Nursing Mothers: It is not known if rivaroxaban is excreted in human milk. Rivaroxaban and/or its metabolites were excreted into the milk of rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from rivaroxaban, a decision should be made whether to discontinue nursing or discontinue XARELTO®, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: In the EINSTEIN DVT, PE, and Extension clinical studies, approximately 37% were 65 years and over and about 16% were >75 years. In clinical trials the efficacy of XARELTO® in the elderly (65 years or older) was similar to that seen in patients younger than 65 years. Both thrombotic and bleedi