![]() Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. Intrarosa - Clinical Pharmacology Mechanism of Action The structural formula is:Įach Intrarosa (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol). Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). It has the empirical formula C 19H 28O 2 with a molecular weight of 288.424 g/mol. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. Intrarosa (prasterone) vaginal insert is a vaginally administered steroid. The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied. The effect of renal impairment on the pharmacokinetics of prasterone has not been studied. Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older. Safety and effectiveness have not been established in pediatric patients. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production. Intrarosa is indicated only in postmenopausal women. Animal reproduction studies have not been conducted with prasterone. There are no data with Intrarosa use in pregnant women regarding any drug-associated risks. The eleven (11) cases of abnormal Pap smear at 52 weeks include one (1) case of low-grade squamous intraepithelial lesion (LSIL), and ten (10) cases of atypical cells of undetermined significance (ASCUS). There were 74 cases of vaginal discharge (14.2 percent) and 11 cases of abnormal Pap smear (2.1 percent) in 521 participating postmenopausal women. In a 52-week non-comparative clinical trial, vaginal discharge and abnormal Pap smear at 52 weeks were the most frequently reported treatment-emergent adverse reaction in women receiving Intrarosa with an incidence of ≥ 2 percent. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the Intrarosa treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment group. In four (4) placebo-controlled, 12-week clinical trials, vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the Intrarosa treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. Adverse Reactions Clinical Trials Experienceīecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intrarosa has not been studied in women with a history of breast cancer. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. ![]() Warnings and Precautions Current or Past History of Breast CancerĮstrogen is a metabolite of prasterone. ![]() ![]() Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with Intrarosa. Vaginal insert: 6.5 mg of prasterone, smooth, white to off-white solid fat bullet-shaped, measuring 28 mm in length, 9 mm in width at its wider end, and weighing 1.2 gram. Related/similar drugs estradiol topical, Imvexxy, Osphena, ospemifene, dehydroepiandrosterone Intrarosa Dosage and AdministrationĪdminister one Intrarosa vaginal insert once daily at bedtime, using the provided applicator.
0 Comments
Leave a Reply. |