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!

What is Osphena At Home®?
Osphena At Home® offers home-delivery pharmacy service to eligible patients (as described below). This concierge program offered by Duchesnay USA provides discreet monthly home delivery of your prescription by mail. It also offers insurance benefit verification, prior authorization support, automatic refill services or and reminder telephone calls when it’s time to refill your Osphena® prescription. The program is offered through ProCare Rx specialty pharmacy, which has certified pharmacy technicians and pharmacists available to answer any questions you may have about the program.
Who can I call for questions about Osphena At Home® or to enroll?
Call 1-844-716-HOME (4663) Monday to Friday, from 8 am to 8 pm EST.
How can I enroll in the Osphena At Home® program?
There are several ways to enroll:
  • Online at Osphena.com: Once you have completed all available fields and hit submit, a ProCare Rx Pharmacy representative will contact you within 24 hours to confirm your registration
  • By telephone: Call 1-844-716-HOME (4663) to speak to a ProCare Rx Pharmacy representative who will confirm your address and insurance information, explain the program and provide you with your insurance co-pay and delivery options
  • At your healthcare provider’s office: During your office visit, ask your healthcare provider about the program so that he/she can fax your prescription or e-prescribe directly to us. Once the fax or e-prescription has been received, a ProCare Rx Pharmacy representative will contact you to confirm your address and insurance information and provide you with your co-pay amount and delivery options
How long does it take to enroll?
Enrolling online or by telephone takes just a few minutes. If you enroll online and we have any questions, we will follow up with you by telephone. If you enroll by telephone, a ProCare Rx Pharmacy representative will confirm your information (address and insurance information), explain the program and provide you with your insurance co-pay and delivery options. Please click here to read our Privacy Policy.
What if my insurance does not cover Osphena®?
Coverage for Osphena® is determined by your insurer. However, if your insurer places restrictions on coverage for Osphena®, we can initiate a prior authorization to see if your insurance will approve it; this can take 24-48 hours. ProCare Rx Pharmacy will also work with your doctor’s office to help address any of these restrictions.
If I have commercial insurance coverage, can I still use a savings offer if I participate in Osphena At Home®?
Patients who enroll in Osphena At Home® may be eligible for the Osphena Savings Card program. Remember that you must have a valid prescription for Osphena® to be eligible for the savings offer. ProCare Rx Pharmacy will apply the Osphena Savings Card and let you know what your out-of-pocket cost will be.
I have Medicare Part D insurance. Can I participate in the Osphena At Home® program?
Yes. Medicare Part D cash-paying patients may get a 30-day supply of Osphena for $40 or a 90-day supply for $80.
  • This offer 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
  • The out-of-pocket expense incurred cannot be applied toward Medicare Part D true out-of-pocket (TrOOP) expenses
How does enrollment work if I have Medicare Part D insurance?
While enrolling in Osphena At Home®, ProCare Rx Pharmacy will verify that Osphena® is not covered under your Medicare insurance plan
  • Once this is confirmed, you may be able to receive Osphena for $40 for a 30-day supply or $80 for a 90-day supply
  • This offer 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 programs
  • If you are enrolled in a Medicare Part D prescription plan, you are eligible for this offer 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 must comply with any terms of your health insurance plan requiring notification to your plan of the existence and/or value of this offer
  • Enrollment is easy and can be done by telephone, on www.Osphena.com, or during a visit to your doctor. See question 2 of this section about enrollment.
Do I have to pay for shipping?
No, shipping is included with your prescription order.
How can I check my order status?
Once your prescription has been shipped, we will provide you with a tracking number and link or you may call 1-844-716-HOME (4663).
Can I sign up for automatic refills?
Yes, we offer a convenient refill service that will ensure that your prescription is refilled and shipped to you automatically every month for the length of your prescription. Using the automatic refill service means ProCare Rx will keep your credit card number on file. If you prefer that ProCare Rx not keep your credit card number on file, you can request a monthly reminder call one week prior to your refill date.
I have no more refills. Can you call my doctor to renew my prescription?
Yes, we would be happy to call your doctor on your behalf.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®.
Can I request Osphena product information?
Yes, we can provide you with additional information regarding the product. When we ship your order, it will include some patient information about Osphena® to help you get started.
I already have an active prescription for Osphena. How can I enroll in the Osphena At Home® program?
Call us at 1-844-716-HOME (4663) and we will assist you in transferring your prescription to ProCare Rx Pharmacy.
What if I don’t have a prescription for Osphena yet?
You need a valid prescription for Osphena® to enroll in the Osphena At Home® program. We suggest that you talk to your healthcare provider to see if Osphena® is right for you.

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