Important Safety Information Including Boxed Warning and Indication

Most Important Information you should know about Osphena®

Osphena® 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. 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 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 have had blood clots, have 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 of Osphena®

Serious but less common side effects can include stroke, blood clots and cancer of the lining of the uterus.

Common side effects may include hot flashes, vaginal discharge, muscle spasms and increased sweating.

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.

Indication: What is Osphena®?

Osphena® is a prescription oral pill that treats moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.

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

For U.S. Residents Only
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!

If I am enrolled in Medicare Part D and I want to pay cash for my Osphena® prescriptions, am I eligible for the Osphena Savings Card?
The Osphena Savings Card is not valid for prescriptions covered by or submitted for reimbursement to Medicare, Medicaid, TRICARE, or similar federal or state programs, including any state pharmaceutical assistance program.
If you are enrolled in a Medicare Part D prescription plan, you are eligible for the Osphena Savings Card under the following conditions:
  1. Patients may not submit any claim for Osphena® to their Part D plan or to any other health insurance program; and
  2. Patients may not submit the amount they pay for Osphena® to their Part D plan to count toward true out-of-pocket expenses (TrOOP), and
  3. Patients must comply with any terms of their health insurance plan requiring notification to their plan of the existence and/or value of this offer.
If I am enrolled in Medicare Part D and I want to use the Osphena Savings Card, do I need to inform the pharmacist that I am a Medicare Part D cash-paying patient?
No, you are not required to inform the pharmacist that you are a Medicare Part D cash-paying patient; however, you must agree to the Full Terms, Conditions, Eligibility Rules, and Patient Information on the reverse of the Osphena Savings Card.
If you are enrolled in a Medicare Part D prescription plan, you are eligible for the Osphena Savings Program under the following conditions:
  1. You may not submit any claim for Osphena® to your Part D plan or to any other health insurance program; and
  2. You may not submit the amount you pay for Osphena® to your Part D plan to count toward true out-of-pocket expenses (TrOOP), and
  3. You will comply with any terms of your health insurance plan requiring notification to your plan of the existence and/or value of this offer.
What should I do if my pharmacist believes that Medicare Part D patients are not eligible for the Osphena Savings Card?
You can ask them to review the Full Terms, Conditions, Eligibility Rules, and Patient Information on the back of your Osphena Savings Card or in the Osphena Savings Card brochure. If your pharmacist still has questions, they can call one of the phone numbers listed on the back of your Osphena Savings Card.
Can the Osphena Savings Card be used for prescriptions reimbursed under Medicaid or TRICARE?
No. The Osphena Savings Card is not valid for prescriptions covered by or submitted for reimbursement to Medicaid, TRICARE, or similar federal or state programs, including any state pharmaceutical assistance program.
See the Full Terms, Conditions, Eligibility Rules, and Patient Information on the back of your Osphena Savings Card.
What if I have Medicare and Medicaid?
Dual-eligible patients are not eligible for the Osphena Savings Card.

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