Intrarosa is the FIRST AND ONLY FDA-APPROVED NON-ESTROGEN THERAPY WITH PRASTERONE

Intrarosa is the FIRST AND ONLY FDA-APPROVED NON-ESTROGEN THERAPY WITH PRASTERONE1

Intrarosa is the FIRST AND ONLY FDA-APPROVED NON-ESTROGEN THERAPY WITH PRASTERONE

Prasterone is a synthetic version of endogenous DHEA1

Prasterone steroidogenesis1

  • Prasterone, an inactive endogenous steroid, is converted into 5 biologically active androgens and estrogens (testosterone, dihydrotestosterone, 17β-diol, estrone, and estradiol). The mechanism of action of INTRAROSA is not fully established1,2
  • Exogenous prasterone is metabolized in the same manner as endogenous prasterone1
  • Human steroidogenic enzymes transform prasterone into androgen and estrogen sex steroids1
DHEA=dehydroepiandrosterone.
Intrarosa applicator insert
Not actual size.
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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.

References: 1. Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2018. 2. Labrie F, Labrie C. DHEA and intracrinology at menopause, a positive choice for evolution of the human species. Climacteric. 2013;16(2):205-213.