Osphena is a non-estrogen medicine that reverses certain changes in vaginal tissue that are caused by menopause.

Osphena is a prescription medicine used in menopausal women to relieve moderate to severe vaginal dryness.

Osphena is also used to treat moderate to severe pain during sexual intercourse.

You should not use Osphena if you have: undiagnosed vaginal bleeding, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use Osphena if you are pregnant.

Osphena may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Osphena tablets are usually taken once daily. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take this medicine with food.

Osphena may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular pelvic exams and mammograms while taking Osphena.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Osphena.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Dyspareunia:

60 mg orally once a day with food

Comments:
-This drug should be used for the shortest duration consistent with treatment goals and risks; postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

Uses: For the treatment of moderate to severe dyspareunia (painful intercourse) and moderate to severe vaginal dryness, both symptoms of vulvar and vaginal atrophy, due to menopause.

You should not use Osphena if you are allergic to ospemifene, if you are pregnant, or if you have:

• a history of heart attack, stroke, or blood clot;

• unusual vaginal bleeding that a doctor has not checked; or

• any type of breast, uterine, or hormone-dependent cancer.

Some drugs should not be used together with Osphena. Your doctor may change your treatment plan if you also use:

• bazedoxifene;

• clomiphene;

• fluconazole;

• rifampin;

• tamoxifen;

• toremifene;

• birth control pills; or

• hormone replacement therapy.

To make sure Osphena is safe for you, tell your doctor if you have ever had:

• liver disease;

• breast cancer (in you or a family member); or

• risk factors for heart problems or blood clots (such as diabetes, smoking, being overweight, having high blood pressure, high cholesterol, or lupus).

Ospemifene may increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk with your doctor about your individual risks.

Do not use ospemifene if you are pregnant or plan to become pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while using this medicine.

Osphena is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction to Osphena: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot deep in the body - swelling, warmth, or redness in an arm or leg; or

• any unusual vaginal bleeding.

Common Osphena side effects may include:

• vaginal discharge or heavy bleeding;

• hot flashes;

• headache;

• increased sweating, night sweats; or

• muscle spasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• birth control pills; or

• hormone replacement therapy.