You are now leaving Osphena.com

This information is intended only for U.S. healthcare professionals. If you are a U.S. healthcare professional, click "I Agree" to continue. If you are a Canadian healthcare professional, please visit osphena.ca.

I Agree

How Osphena® helpsOsphena® improves the health of specific vaginal tissue in just 12 weeks

How Osphena® helpsOsphena® improves the health of specific vaginal tissue in just 12 weeks

Vaginal changes due to menopause

Before menopause, estrogen helps maintainAfter menopause, falling estrogen levels mean
Thickness and elasticity (stretchiness) of your vaginal tissue Your vagina becomes shorter and narrower and your vaginal lining becomes thinner and less elastic
Sufficient blood vessels in your vaginal walls Less blood flows to your vagina
Good lubrication during daily and sexual activities Your vagina produces fewer secretions, resulting in less lubrication during sexual stimulation

Although Osphena® is taken by mouth, it works in your vagina to increase the number of one type of cell (superficial cells), decrease the number of another type of cell (parabasal cells) and helps reduce vaginal pH to help relieve both moderate to severe vaginal dryness and moderate to severe painful sex due to menopause.

How effective is Osphena®?

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

graph 12weeks
 

How safe is Osphena®?

Osphena® is not an estrogen. It is a non-hormonal treatment that specifically targets vaginal tissue.

Osphena®'s safety has been confirmed in multiple clinical trials. It has been prescribed over 1 million times since its launch in 2013 and is recommended as Level A treatment for dyspareunia (meaning that it is supported by the highest level of clinical evidence) by the American College of Obstetricians and Gynecologists (ACOG) and the North American Menopause Society (NAMS).

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

 

How to take Osphena®?

Take one 60 mg Osphena® tablet once daily, by mouth, with food.

If you miss a dose, wait until your next regularly scheduled pill. Do not take two pills in the same day.

Osphena® should be taken for the shortest duration consistent with treatment goals and risks for the individual woman.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING AND INDICATION

Indication: What is Osphena?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

Most Important Information you should know about Osphena

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.

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, 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 Patient Information for Osphena (ospemifene) tablets, including Boxed Warning and the Full Prescribing Information.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION: WHAT IS OSPHENA?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

See full Prescribing Information for complete Boxed Warning.

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION: WHAT IS OSPHENA?

Osphena is a prescription oral pill that treats moderate to severe painful intercourse and/or moderate to severe vaginal dryness, both symptoms of changes in your vagina, due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS

See full Prescribing Information for complete Boxed Warning.

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.