INTRAROSA

What it is

INTRAROSA is a prasterone 6.5 mg pessary . It is a white to off-white, bullet-shaped pessary, approximately 28 mm long and 9 mm in diameter at its widest end . Prasterone is biochemically and biologically identical to endogenous human dehydroepiandrosterone (DHEA), a precursor steroid that is converted into oestrogens and androgens . These metabolites formed from prasterone activate oestrogen and androgen receptors, making INTRAROSA different from oestrogen preparations since it also delivers androgen metabolites .

Approved indications

— Treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms .

Dosing overview

INTRAROSA is administered intravaginally with the use of the provided applicator or with fingers, with one pessary administered once a day at bedtime .

Key safety warnings

Oestrogen is a metabolite of prasterone, and in women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods . Endometrial safety of long-term local vaginally administered prasterone has not been studied for more than one year, and therefore if repeated, treatment should be reviewed at least annually . If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy . The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen–progestogen and possibly also oestrogen-only systemic HRT, dependent on the duration of taking HRT, with the excess risk becoming apparent within a few years of use but returning to baseline within a few years after stopping treatment . Systemic HRT is associated with a 1.3–3-fold risk of developing venous thromboembolism (VTE), with the occurrence of such an event more likely in the first year of HRT than later . Systemic oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke, with the relative risk not changing with age or time since menopause, but as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age . This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information .

Contraindications

INTRAROSA is contraindicated in women with hypersensitivity to the active substance or to the excipient; undiagnosed genital bleeding; known, past or suspected breast cancer; known or suspected oestrogen-dependent malignant tumours (for example, endometrial cancer); untreated endometrial hyperplasia; known or suspected pregnancy; acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal; previous or current venous thromboembolism (VTE) including deep vein thrombosis or pulmonary embolism; known thrombophilic disorders (for example, protein C, protein S, or antithrombin deficiency); active or recent arterial thromboembolic disease (for example, angina, myocardial infarction); and porphyria .

PBS listing

No information regarding PBS listing is available in the provided source documents.

Regulatory history

INTRAROSA prasterone 6.5 mg pessary blister pack was first listed on the Australian Register of Therapeutic Goods on 16 June 2023 . The approval date was 15 June 2023 for the indication of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms .