Intrarosa (prasterone (DHEA))
Vaginal Estrogens Vaginal Insert
Last reviewed · Source: First Databank (FDB) drug data
Overview
Prasterone is an inactive endogenous steroid that is converted intracellularly into active androgens and/or estrogens.
Prasterone (i.e., dehydroepiandrosterone (DHEA)) is an inactive endogenous steroid that is converted intracellularly into active androgens and/or estrogens. Although the exact mechanism of action of prasterone in the treatment of vulvar and vaginal atrophy in postmenopausal women is not fully established, clinical studies demonstrate that intravaginal application of the drug exhibits both androgenic and estrogenic activity. (See Uses: Dyspareunia.) Intravaginal administration of prasterone for up to 52 weeks does not have a stimulatory effect on the endometrium, but an increased incidence of abnormal Papanicolaou test (Pap smear) results was observed.
Following administration of prasterone 6.5 mg intravaginally for 7 days, the mean peak plasma concentrations and AUC of prasterone were substantially higher than those in patients who received placebo. At 12 weeks, serum trough prasterone concentrations increased 47% from baseline. Exogenous and endogenous prasterone are metabolized by human steroidogenic enzymes (e.g., hydroxysteroid dehydrogenases, 5alpha-reductases, aromatases) to form androgen and estrogen metabolites.
Peak plasma concentrations of testosterone and estradiol, metabolites of prasterone, were slightly higher in patients receiving prasterone than in those who received placebo; after intravaginal administration of prasterone for 12 weeks, testosterone and estradiol serum trough concentrations increased 21 and 19%, respectively, from baseline. However, systemic concentrations of estrogens and androgens remained within the expected range for postmenopausal women.
USES: This medication is used by women after menopause to treat painful sexual intercourse. Painful intercourse can be a symptom of changes in and around your vagina, due to menopause. Prasterone belongs to a class of drugs known as steroids.
It is not well understood how it works to lessen painful intercourse, but prasterone is changed in the body to certain hormones (androgens and estrogens).
Generic name: prasterone (DHEA)
Pronunciation: (PRAS-ter-one)
Drug class: Vaginal Estrogens
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Intrarosa
Indications
The following indications are listed for Intrarosa:
- Dyspareunia Due To Menopause-Associated Vulvovaginal Atrophy
Dosing
No dosing information is available for this tab.
Prasterone vaginal inserts are administered intravaginally using the disposable applicator provided by the manufacturer.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Intrarosa 6.5 Mg Vag Insert | Maintenance | Insert 1 vaginal insert (6.5 mg) by vaginal route once daily at bedtime. |
No dosing information is available for this tab.
Drug interactions
Drug interaction studies have not been performed using prasterone vaginal inserts.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Prasterone is contraindicated in postmenopausal women with undiagnosed abnormal genital bleeding. The cause of undiagnosed, persistent, or recurrent genital bleeding should be determined prior to considering therapy with the drug.
- Lactation
- Pregnancy
- Prostatic carcinoma
- Disease of liver
- Diabetes mellitus
Adverse reactions
In the 12-week, placebo-controlled trials, vaginal discharge occurred in at least 2% of patients receiving prasterone and more frequently than in those receiving placebo. Adverse effects occurring in at least 2% of patients receiving prasterone for up to 52 weeks included vaginal discharge and abnormal Papanicolaou test (Pap smear).
Less Frequent
- Nonspecific abnormal papanicolaou smear of cervix
More Frequent
- Vaginal discharge
Precautions
No enhanced messaging available.
Safety and efficacy of prasterone have not been established in pediatric patients; the drug is not indicated in pediatric patients.
Prasterone has not been studied in pregnant women and animal reproduction studies have not been conducted. The manufacturer states that the drug is labeled for use only in postmenopausal women.
It is not known whether prasterone is distributed into human milk. Effects of the drug on the breast-fed infant or milk production also are unknown.
Of the prasterone-treated postmenopausal women enrolled in the placebo-controlled 12-week clinical trials and the open-label 52-week study, 19 and 11% of patients, respectively, were 65 years of age or older.
ICD codes
| Code | Type | Description |
|---|---|---|
| Dyspareunia due to menopause-associated vulvovaginal atrophy | ||
| N95.2 | ICD10CM | Postmenopausal atrophic vaginitis |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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