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OSPHENA is a medication that works like estrogen in the lining of the uterus (womb), but can work differently in other parts of the body.
Taking estrogen-alone or OSPHENA may increase your chance of getting cancer of the lining of the uterus (womb). Vaginal bleeding after menopause may be a warning sign of cancer of the lining of uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Tell your healthcare provider right away if you have any unusual vaginal bleeding right away while you are taking OSPHENA.
OSPHENA may increase your chance of getting strokes and blood clots.
You and your healthcare provider should talk regularly about whether you still need treatment with OSPHENA.
What is OSPHENA?
OSPHENA is an oral prescription medicine used to treat painful intercourse, a symptom of changes in and around your vagina, due to menopause.
Who should not take OSPHENA?
Do not start taking OSPHENA if you:
have unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
currently have or have had certain cancers
Estrogen may increase the chances of getting certain types of cancers, such as cancer of the lining of the uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take OSPHENA.
currently have or have had blood clots
had a stroke or heart attack
think you may be pregnant
OSPHENA is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take OSPHENA if the test is positive and talk to your healthcare provider.
What should I tell my healthcare provider before taking OSPHENA?
Before you take OSPHENA, tell your healthcare provider if you:
have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
have any other medical conditions
Such as severe liver problems.
are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop taking OSPHENA.
are breast feeding
It is not known if OSPHENA can pass into your breast milk.
Tell your healthcare provider about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how OSPHENA works. OSPHENA may also affect how other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take OSPHENA?
Take OSPHENA exactly how your healthcare provider tells you to take it.
Take OSPHENA by mouth 1 time each day with food.
You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether or not you still need treatment with OSPHENA.
What are the possible side effects of OSPHENA?
See “What is the most important information I should know about OSPHENA?”
Serious, but less common side effects include:
stroke
blood clots
cancer of the lining of the uterus (womb)
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
