Important Safety Information Including Boxed Warning and Indication

WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS

Osphena® works like estrogen in the lining of the uterus (endometrium), 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. 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 him or her right away if this happens while you are using Osphena®.

Osphena® may increase your chances of having a stroke or blood clots.

You and your healthcare provider should talk regularly about whether you still need treatment with Osphena®.

Indication: What is Osphena®?

Osphena® is a prescription oral pill that treats:

  • moderate to severe painful intercourse,
  • moderate to severe vaginal dryness, symptoms of changes in and around your vagina, due to menopause.

Most Important Information you should know about Osphena®

Call your healthcare provider right away if you have unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, and pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Who should not take OSPHENA?

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 have had blood clots, had a stroke or heart attack, have severe liver problems, are allergic to Osphena® or any of its ingredients, 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
  • cancer of the lining of the uterus

Less serious, but common side effects include:

  • hot flushes or flashes
  • vaginal discharge
  • muscle spasms
  • headache
  • excessive sweating (hyperhidrosis)
  • heavy vaginal bleeding (vaginal hemorrhage)
  • night sweats

Tell your healthcare provider about all of the medicines and supplements you take, as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work.

Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read accompanying Patient Information for Osphena®(ospemifene) tablets, including Boxed Warning in the U.S. Full Prescribing Information.

NEW!
Osphena® now also indicated for moderate to severe vaginal dryness, a symptom of changes in and around your vagina due to menopause
Learn more
How Osphena® Helps

Osphena is the only oral, hormone-free treatment for moderate to severe painful sex due to menopause

Find answers to your questions about Osphena® here!

What is Osphena®?
Osphena® is the only FDA-approved oral pill for the treatment of moderate to severe dyspareunia (painful sex), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. It's not an estrogen, but it works like one to help improve specific vaginal tissue* and help relieve moderate to severe painful sex due to menopause.
*Increases superficial cells, decreases parabasal cells (these are two types of vaginal cells) and reduces vaginal pH.
What causes painful sex due to menopause?
Before menopause, high levels of estrogen stimulate maturation of the vaginal epithelium to generate a thick layer of mature superficial cells. After menopause, a lack of estrogen leaves the epithelium much thinner, with very few or no superficial cells. In many women, this thinning is associated with vaginal dryness, irritation, itching and pain with intercourse, a condition referred to as vaginal atrophy or atrophic vaginitis1.
How soon can I expect results with Osphena®?
In clinical studies, most women reported relief of moderate to severe painful sex due to menopause in as little as 12 weeks after beginning treatment with Osphena®. 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®.
Do over-the-counter lubricants help?
Many women with moderate to severe painful sex after menopause use lubricants to make sex less painful. However, lubricants only provide temporary relief and do nothing to treat the underlying condition that causes painful sex. It is important to know that if left untreated, painful sex can get worse. That’s why, if you're experiencing moderate to severe painful sex, you should talk to your healthcare provider about Osphena®. With continued use, Osphena® can improve specific vaginal tissue* and help relieve moderate to severe painful sex due to menopause.
*Increases superficial cells, decreases parabasal cells (two types of vaginal cells) and reduces vaginal pH.
Who should not take Osphena®?
Osphena® is not for everyone. Do not take Osphena® 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
  • Have had a stroke or heart attack
  • Have severe liver problems
  • Are allergic to Osphena® or any of its ingredients
  • Think you may be pregnant
Tell your healthcare provider if you are going to have surgery or will be on bed rest.
What if I have a medical question about Osphena®?
You can call 1-855-Osphena (1-855-677-4362), Monday to Friday, from 8:30 am to 4:30 pm EST.

1 Reiter S. Barriers to effective treatment of vaginal atrophy with local estrogen therapy. International Journal of General Medicine. 2013;6:153-158. doi:10.2147/IJGM.S43192

Want to speak to an Osphena® representative?

Call 1-855-OSPHENA
1-855-677-4362

Monday to Friday
8:30 am to 5:30 pm EST

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Information

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