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 plant-derived version of endogenous DHEA2

Prasterone steroidogenesis1

  • Prasterone, an inactive steroid, is converted into biologically active androgens and estrogens. The mechanism of action of INTRAROSA is not fully established1
  • Exogenous prasterone is metabolized in the same manner as endogenous prasterone1
  • In humans, intracellular steroidogenic enzymes transform prasterone into the sex steroids – androgens and estrogens1
DHEA=dehydroepiandrosterone.
Intrarosa applicator insert
Not actual size.
See More

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. Origin Statement. Veracruz, MX: Productos Químicos Naturales S.A. de C.V (Proquina). 2017.