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

NEW! Osphena®

Now also indicated for moderate to severe vaginal dryness, a symptom of changes in and around your vagina due to menopause

Bothered by vaginal dryness due to menopause?

You are not alone! In fact, vaginal dryness is the most common bothersome symptom of menopause.

79% of women experiencing changes in and around the vagina due to menopause (a condition called vulvar and vaginal atrophy or VVA) report symptoms of vaginal dryness.

Many women do not seek help for vaginal dryness because they believe it is just a natural part of aging that will eventually go away on its own.

The truth is that if vaginal dryness is left untreated, it can get worse.

That is why it is so important to talk to your healthcare provider about your symptoms and ask if once-daily Osphena® could be the right treatment for you.

Osphena® is the first and only treatment for moderate to severe vaginal dryness, a symptom of VVA due to menopause, that is:

Non-hormonal

Osphena® is NOT an estrogen

Taken by mouth

No vaginal application required

Convenient

Once daily dosing

Acts locally

Affects certain vaginal tissue that may be causing discomfort

Osphena®'s safety and effectiveness have been confirmed in multiple clinical trials

Osphena® has been prescribed over 1 million times since its launch in 2013.

RESULTS AFTER 12 WEEKS OF TREATMENT

After just 12 weeks of treatment, studies showed Osphena® helped increase the proportion of superficial cells – cells that you need more of – and decrease the proportion of parabasal cells – cells that you need less of – to maintain vaginal health.

 

Save on your Osphena® prescription

If you have commercial insurance, you could pay as little as $0 per prescription with the Osphena® CoPay Savings Card or through the Osphena At Home® free home delivery service.

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

Please see Important Safety Information and Full Prescribing Information, including Boxed Warning regarding Endometrial Cancer and Cardiovascular Disorders.

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

If you’re looking for additional information about Osphena®, click below to view our Frequently Asked Questions.

Get Answers to Questions About Osphena®

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Savings

Duchesnay USA offers great savings programs that may make this treatment option affordable.

Save on Your Osphena® Prescription

For U.S. Residents Only