Intrarosa (Prasterone)

Intrarosa (prasterone) is used to manage vulvovaginal atrophy, a condition that commonly affects postmenopausal women.

• Dyspareunia associated with vulvar and vaginal atrophy: reduces pain during sexual activity by improving vaginal lubrication and epithelial maturation.
• Vulvar atrophy: enhances tissue elasticity and reduces dryness, contributing to comfort.
• Vaginal atrophy: promotes epithelial cell maturation and moisture, alleviating symptoms of dryness and irritation.
• Postmenopausal vaginal health: supports natural hormone balance locally, helping maintain vaginal pH and microbiome.

• Prasterone is a steroid precursor that, when placed in the vagina, is enzymatically converted by local 3β‑hydroxysteroid dehydrogenase into both estrogenic (estradiol) and androgenic (DHEA) metabolites. These hormones bind to estrogen and androgen receptors in the vaginal epithelium, stimulating cell proliferation, glycogen synthesis, and increased vascularization, which together improve tissue thickness, lubrication, elasticity, and overall comfort.

The most frequently reported adverse reactions with Intrarosa are generally mild and localized to the vaginal area.

Common Side Effects

• Vaginal discharge: watery or milky fluid may be observed.
• Vaginal irritation or itching: mild discomfort at the insertion site.
• Headache: occasional mild headache.
• Abdominal pain: mild lower abdominal discomfort.
• Nausea: occasional feeling of nausea.
• Vaginal spotting: light spotting may occur.

Serious or Rare Side Effects

• Severe allergic reaction: signs include rash, swelling, or anaphylaxis.
• Significant vaginal bleeding: heavy bleeding requiring medical attention.
• Pelvic pain: persistent or worsening pelvic discomfort.
• Breast tenderness: unusual sensitivity or pain in the breasts.

Before prescribing Intrarosa, clinicians should consider several precautionary measures to ensure patient safety.

• Pregnancy: avoid use because safety has not been established.
• Breastfeeding: not recommended due to unknown effects on the infant.
• Hormone‑sensitive cancers: use with caution in patients with a history of estrogen‑ or androgen‑dependent tumors.
• Severe liver disease: contraindicated as metabolism may be impaired.
• Known hypersensitivity: do not use in patients allergic to prasterone or any excipients.
• Store at room temperature below 25 °C: keep in the original packaging, protect from moisture and direct sunlight.

Intrarosa may interact with other medications, primarily through hormonal pathways or local vaginal absorption.

Major Interactions (Avoid)

• Systemic estrogen therapy: may increase overall hormonal exposure and risk of side effects.
• Androgenic drugs: additive hormonal effects could lead to excessive androgen activity.
• Vaginal antifungal or antibacterial agents: may alter the absorption or effectiveness of the insert.

Moderate Interactions (Monitor Closely)

• CYP3A4 inhibitors: could affect local metabolism of prasterone metabolites.
• Anticoagulants: monitor for increased vaginal bleeding when using the product.