Evista

[Raloxifene]

Pregnancy

Category X

EVISTA should not be used in women who are or may become pregnant (see CONTRAINDICATIONS).

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Nursing Mothers

EVISTA should not be used by lactating women (see CONTRAINDICATIONS). It is not known whether raloxifene is excreted in human milk.

Pediatric Use

EVISTA should not be used in pediatric patients.

Geriatric Use

In the osteoporosis treatment trial of 7705 postmenopausal women, 4621 women were considered geriatric (greater than 65 years old). Of these, 845 women were greater than 75 years old. Safety and efficacy in older and younger postmenopausal women in the osteoporosis treatment trial appeared to be comparable.

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