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AMAG Pharmaceuticals is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives.
To learn more about other INTRAROSA and other AMAG Pharmaceuticals products and services, please contact Customer Service at 1­-877-411-2510.
To report SUSPECTED ADVERSE REACTIONS, call AMAG Pharmaceuticals at 1­-877-411-2510 or the FDA at 1­-800-FDA-1088 or visit www.fda.gov/medwatch.
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Indication

INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Important Safety Information

INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding.

Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.

In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal Pap smear.

To report SUSPECTED ADVERSE REACTIONS, contact AMAG Pharmaceuticals at 1­-877-411-2510 or FDA at 1-800­-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.