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Medication Class: Selective Estrogen Receptor Modulator
Manufacturer: Shinogi Inc
Approval Date: February 2013
What is Osphena and its mechanism of action
Estrogen is needed for vaginal lubrication and to increase the vaginal wall. Menopause causes a significant reduction in estrogen and changes in the vaginal wall that can result in painful sex (dyspareunia). Osphena binds to estrogen receptors and mimics the action of estrogen in some tissues or blocks the action of estrogen in other tissues Osphena works like estrogen in the lining of the uterus (womb).
What does Osphena treat
Osphena is an oral prescription medication used for the treatment of painful sexual intercourse (dyspaneuria) resulting from changes in and around the vagina due to menopause.
How effective is Osphena
The effectiveness and safety of Osphena on moderate to severe symptoms of painful sexual intercourse in postmenopausal women were examined in two 12-week efficacy trials and one 52-week long term safety trial. A total of 787 women received placebo (sugar pill) while 1102 women received 60 mg Osphena.
In the 1st and 2nd study, women who were treated with Osphena compared to placebo, demonstrated significant relief in moderate to severe most bothersome symptom of painful sexual intercourse (for example, pain, vaginal dryness, vaginal irritation/itching). Also a laboratory test showed improvement in the wall of the vagina for the women who took Osphena.
Interesting facts about Osphena
Osphena is the first non-estrogen tablet that reverses the physical changes of the vagina.
Osphena is not for treatment of decreased libido in women
Osphena has varying side effects based on the presence or absence of an intact uterus.
Patients with intact uterus should also take progesterone, to help decrease the risk of cancer of the lining of the uterus (womb).
Osphena should be taken with food?
Also Read: 11 Facts about Osphena
What are Osphena Side effects
Serious: Stroke, blood clots, and cancer of the lining of the uterus
Common: Hot flashes, vaginal discharge, muscle spasms, increased sweating (hyperhidrosis)
Osphena may increase the chances of getting strokes and blood clots
Taking Osphena may increase the chance of getting cancer of the lining of the uterus (womb). Any unusual bleeding should be evaluated immediately.
What is the dosage of Osphena
Osphena is available in 60 mg tablets. The dosage is 60 mg once daily with food.
Osphena Drug Interactions
Fluconazole and ketoconazole increase the concentration of Osphena in the body and this will cause an increase in side effects.
Rifampin decreases Osphena in the body and lowers the effect of Osphena.
What is the cost of Osphena
The wholesale price for a 30 day supply is $153. Price at the local pharmacy is about $199 for a 30 day supply (30 pills).
How to obtain prescription cost assistance for Osphena
Join the inner circle to obtain Osphena savings card.
Osphena (ospemifene) tablets, Full Prescribing Information [PI (package insert)]
Micromedex Retrieved on July 8th, 2013
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