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Osphena
ospemifene
Black Box Warnings .
Endometrial Cancer Risk
estrogenic effects in the endometrium; unopposed estrogen use incr. risk if intact uterus; use adequate diagnostic measures such as endometrial sampling to rule out malignancy if undiagnosed persistent or recurrent abnormal genital bleeding
Cardiovascular Risk
thromboembolic stroke, hemorrhagic stroke, and DVT incidence rates were 1.13, 3.39, and 2.26 per thousand women years w/ ospemifene 60 mg vs. 3.15, 0, and 3.15 w/ placebo, respectively; incr. risk of stroke and DVT (from WHI estrogen-alone substudy) in 50-79 yo postmenopausal pts on a WHI regimen x7.1y; WHI regimen = conj. estrogen 0.625 mg/day; use shortest duration based on individual tx goals and risks
Adult Dosing .
Dosage forms: TAB: 60 mg
dyspareunia, moderate-severe menopausal
- [60 mg PO qd]
- Info: give w/ food; D/C tx >4-6wk before surgery w/ VTE risk
vaginal dryness, moderate-severe menopausal
- [60 mg PO qd]
- Info: give w/ food; D/C tx >4-6wk before surgery w/ VTE risk
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.