Evista

[Raloxifene]

Drug Interactions

Cholestyramine —

Cholestyramine, an anion exchange resin, causes a 60% reduction in the absorption and enterohepatic cycling of raloxifene after a single dose. Co-administration of cholestyramine with EVISTA is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect.

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Warfarin —

In vitro, raloxifene did not interact with the binding of warfarin. The co-administration of EVISTA and warfarin, a coumarin derivative, has been assessed in a single-dose study. In this study, raloxifene had no effect on the pharmacokinetics of warfarin. However, a 10% decrease in prothrombin time was observed in the single-dose study. If EVISTA is given concurrently with warfarin or other coumarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with EVISTA. In the osteoporosis treatment trial, there were no clinically relevant effects of warfarin co-administration on plasma concentrations of raloxifene.

Other Highly Protein-Bound Drugs —

Raloxifene is more than 95% bound to plasma proteins. Other highly protein-bound drugs should not cause clinically relevant changes in EVISTA plasma concentrations. Furthermore, in the osteoporosis treatment trial, there were no clinically relevant effects of co-administration of other highly protein-bound drugs (e. g., gemfibrozil) on plasma concentrations of raloxifene. In vitro, raloxifene did not interact with the binding of phenytoin, tamoxifen, or warfarin (see above). Although not examined, EVISTA might affect the protein binding of other drugs and should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine.

Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis —

In a 21-month carcinogenicity study in mice, there was an increased incidence of ovarian tumors in female animals given 9 to 242 mg/ kg, which included benign and malignant tumors of granulosa/ theca cell origin and benign tumors of epithelial cell origin.

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