Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
Pharmacology
Mechanism of Action
An inactive steroid that is converted into active androgens and/or estrogens; the mechanism of action in postmenopausal women with vulvar and vaginal atrophy is unknown.
Pharmacokinetics/Pharmacodynamics
Metabolism
Metabolized via dehydrogenase, reductase, and aromatase to 2 active metabolites (estradiol and testosterone)
Use: Labeled Indications
Dyspareunia: Treatment of moderate to severe dyspareunia (a symptom of vulvar and vaginal atrophy due to menopause)
Contraindications
Undiagnosed abnormal genital bleeding
Dosage and Administration
Dosing: Adult
Dyspareunia: Females: Intravaginal: 6.5 mg once daily at bedtime
Dosing: Geriatric
Refer to adult dosing.
Administration
Insert in vagina at bedtime using supplied applicator (for one time use only). Empty bladder and wash hands prior to insertion.
Storage
Store at 5°C to 30°C (41°F to 86°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
>10%: Genitourinary: Vaginal discharge (6% to 14%)
1% to 10%: Genitourinary: Abnormal pap smear (2%)
Warnings/Precautions
Concerns related to adverse effects:
- Vaginal discharge: May occur with use.
Disease-related concerns:
- Breast cancer: Use caution in women with a history of known or suspected breast cancer; estrogen is a metabolite of prasterone.
- Vaginal bleeding: Prior to treatment, evaluate and determine cause of any postmenopausal woman with undiagnosed, persistent, or recurring genital bleeding.
Pregnancy
Pregnancy Considerations
Animal reproduction studies have not been conducted with this preparation; this product is only approved for use in postmenopausal women.
Other formulations of prasterone (dehydroepiandrosterone [DHEA]) have been evaluated to improve pregnancy outcomes in women with diminished ovarian reserve (Gleicher 2011; Narkwichean 2013).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience vaginal discharge (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
