Osphena® FAQs Find answers here

Osphena® is the first and only FDA-approved oral pill for the treatment of moderate to severe vaginal dryness and/or moderate to severe dyspareunia (painful sex), symptoms of vulvar and vaginal atrophy (VVA), due to menopause. Osphena® helps improve specific vaginal tissue* to relieve moderate to severe vaginal dryness and 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.

Before menopause, estrogen helps your body produce fluid that keeps the walls of your vagina lubricated. As estrogen levels fall during menopause, your body produces less of this lubricant, which can lead to vaginal dryness.

Before menopause, high levels of estrogen stimulate maturation of the vaginal lining to generate a thick layer of mature superficial cells. After menopause, a lack of estrogen leaves the vaginal lining 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 vaginitis.

In clinical studies, most women reported relief of moderate to severe vaginal dryness and/or 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 about whether or not you still need treatment with Osphena®.

Many women with moderate to severe vaginal dryness use over-the-counter lubricants or moisturizers to provide relief from daily discomfort. Many also use over-the-counter lubricants to make sex less painful. However, lubricants only provide temporary relief and do nothing to treat the underlying causes of vaginal dryness or dyspareunia. It is important to know that if left untreated, both vaginal dryness and dyspareunia can get worse. That’s why, if you're experiencing moderate to severe vaginal dryness and/or dyspareunia due to menopause, you should talk to your healthcare provider about Osphena®. With continued use, Osphena® can improve specific vaginal tissue* and help relieve moderate to severe vaginal dryness and/or dyspareunia due to menopause.

*Increases superficial cells, decreases parabasal cells (two types of vaginal cells) and reduces vaginal pH.

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 have 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.

Take Osphena® exactly how your healthcare provider tells you to take it: once a day, by mouth, with food. Talk with your healthcare provider regularly about whether you should continue treatment with Osphena®.

Tell your healthcare provider about any prescription and non-prescription medicines or supplements you take, as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work.

Yes. Take Osphena® once a day, every day, with food, as directed by your doctor.

Take your next regularly scheduled pill. Do not take two pills in the same day.

Talk with your healthcare provider about whether you should continue treatment with Osphena®.

Yes. However, in clinical studies, fewer women taking Osphena® were using lubricant by week 12.

Osphena At Home®, offered through ProCare Pharmacy Care, provides discreet free home delivery (minimum purchase required), on-staff pharmacists to answer product questions, assistance with insurance benefit verification and monthly refill reminders.

There are several ways to enroll:

  • By telephone: Call 1-844-716-HOME (4663) to speak to a ProCare Pharmacy Care 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 Pharmacy Care representative will contact you to confirm your address and insurance information and provide you with your co-pay amount and delivery options

Enrolling by telephone takes just a few minutes. If your enroll by telephone and we have any questions, we will follow up with you. A ProCare Pharmacy Care 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.

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 Pharmacy Care will also work with your doctor’s office to help address any of these restrictions.

Patients who enroll in Osphena At Home® may be eligible for the Osphena® CoPay Savings Card. Remember that you must have a valid prescription for Osphena® to be eligible for the savings offer. ProCare Pharmacy Care will apply the Osphena® CoPay Savings Card and let you know what your out-of-pocket cost will be.

No, shipping is included with your prescription order. Minimum purchase required.

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).

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.

Yes, we would be happy to call your doctor on your behalf. You and your doctor should talk regularly about whether or not you still need treatment with Osphena®.

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.

Call us at 1-844-716-HOME (4663) and we will assist you in transferring your prescription to ProCare Rx Pharmacy.

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.

No, the Osphena® CoPay Savings Card does not need to be activated before you use it.

The Osphena® CoPay Savings Card does not require that patients wait a specific number of days between prescription refills; however, your individual insurer may limit how quickly they will approve your monthly refill. It is recommended that you check with your insurance provider for details.

Yes. The Osphena® CoPay Savings Card may be used with mail-order purchases with a valid prescription. To redeem the offer, simply provide your mail-order pharmacy with the Osphena® CoPay Savings Card information.

If you misplace or damage your Osphena® CoPay Savings Card, you can download a new one. Your pharmacy may also keep a record of your Osphena® CoPay Savings Card on file.

Although some pharmacies may keep your Osphena® CoPay Savings Card information on file, it’s best to always bring your Osphena® CoPay Savings Card to the pharmacy with your valid Osphena® prescription or refill request.

No, you can only use one Osphena® CoPay Savings Card at a time. Your Osphena® CoPay Savings Card is valid for several uses. You do not need to use a different card each time. Your pharmacy may also keep a record of your Osphena® CoPay Savings Card on file so that you do not have to show your card each time.

Yes. Your out-of-pocket expense can be applied to your deductible.

Yes. The Osphena® CoPay Savings Card is for use ONLY with a valid Osphena® prescription.

The Osphena® CoPay Savings Card is accepted at most retail pharmacies in the United States and Puerto Rico. If a pharmacy decides not to accept the offer, you may receive savings by requesting a rebate check after you have purchased your Osphena® prescription. Simply call the number on the back of your Osphena® CoPay Savings Card for information on how to submit a request for reimbursement.

Duchesnay USA does not offer a patient assistance program at this time.

Yes. Even if you have previously used an Osphena® CoPay Savings Card, you may present a valid prescription at the pharmacy with your new savings card and you will be eligible for the new offer.

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
  • moderate to severe vaginal dryness, symptoms of changes in and around 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 (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 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
  • moderate to severe vaginal dryness, symptoms of changes in and around 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
  • moderate to severe vaginal dryness, symptoms of changes in and around 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.