Rx Item-INTRAROSA PRASTERONE(DHEA) VAGINAL 6.5MG INS 28 BY AMAG PHARMA

For: Dyspareunia

Intrarosa (prasterone) is a once-daily, vaginally administered steroid indicated to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy. These highlights do not include all the information needed to use INTRAROSA� safely and effectively. See full prescribing information for INTRAROSA�.
INTRAROSA� (prasterone) vaginal inserts
Initial U.S. Approval: 2016

INDICATIONS AND USAGE

INTRAROSA� is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1)

DOSAGE AND ADMINISTRATION

One vaginal insert, once daily at bedtime. (2)

DOSAGE FORMS AND STRENGTHS

Vaginal Insert: 6.5 mg of prasterone. (3)

CONTRAINDICATIONS

Undiagnosed abnormal genital bleeding. (4)

WARNINGS AND PRECAUTIONS

Current or Past History of Breast Cancer. (5.1)

ADVERSE REACTIONS

In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ? 2 percent was vaginal discharge. (6.1)

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. (6.1)

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.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2018

Rx Item-INTRAROSA PRASTERONE(DHEA) VAGIN
RX677942

Rx Item-INTRAROSA PRASTERONE(DHEA) VAGIN
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