Drug Detail:Ospemifene (Ospemifene [ os-pem-i-feen ])
Drug Class: Selective estrogen receptor modulators
Usual Adult Dose for Dyspareunia
60 mg orally once a day with food
Comments:
- This drug should be used for the shortest duration consistent with treatment goals and risks; postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
Uses: For the treatment of moderate to severe dyspareunia (painful intercourse) and moderate to severe vaginal dryness, both symptoms of vulvar and vaginal atrophy, due to menopause.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild to moderate liver dysfunction (Child-Pugh Class A and B) : No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Not recommended
Precautions
US BOXED WARNINGS:
- ENDOMETRIAL CANCER: This drug is an estrogen agonist/antagonist with tissue selective effects; it has estrogen agonistic effects in the endometrium. There is a potential increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
- CARDIOVASCULAR DISORDERS: In the clinical trials (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in ospemifene 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the ospemifene 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. This drug should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
- There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogen 0.625 mg alone therapy over 7.1 years as part of the Women's Health Initiative (WHI).
CONTRAINDICATIONS:
- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions
- Active arterial thromboembolic disease (e.g., stroke and myocardial infarctions, or a history of these conditions)
- Hypersensitivity (e.g., angioedema, urticaria, rash, pruritus) to the active substance or any product excipients -Women who are or may become pregnant
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day with food
General:
- This drug should be used for the shortest duration consistent with treatment goals and risks; periodically re-evaluate to determine if treatment is still necessary.
Monitor:
- For women with undiagnosed persistent or recurring abnormal genital bleeding: adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be performed to rule out malignancy
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Patients should report unusual vaginal bleeding as soon as possible.
- This drug may initiate or increase the occurrence of hot flashes in some women.
