Indication and Important Safety Information
What is Osphena?
Most Important Information You Should Know About Osphena®
Osphena® (ospemifene) works like estrogen in the lining of the uterus, but can work differently in other parts of the body.
Taking estrogen alone or Osphena® may increase your chance for getting cancer of the lining of the uterus, strokes, and blood clots. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell them right away if this happens while you are using Osphena®.
You and your healthcare provider should talk regularly about whether you still need treatment with Osphena®.
Call your healthcare provider right away if you get changes in vision or speech, sudden new severe headaches, and severe pains in your chest or legs with or without shortness of breath, weakness and fatigue. Osphena® should not be used if you have unusual vaginal bleeding; have or have had certain types of cancers (including cancer of the breast or uterus); have or had blood clots; had a stroke or heart attack; have severe liver problems; or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.
Possible Side Effects
Serious but less common side effects can include stroke, blood clots, and cancer of the lining of the uterus.
Common side effects can include hot flashes, vaginal discharge, muscle spasms and increased sweating.
Tell your healthcare provider about all of the medicines you take as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work.
Please read the Patient Information for Osphena® (ospemifene) tablets, including Boxed WARNING in the Full Prescribing Information.