Osphena

Generic name: Ospemifene
Drug class: Selective estrogen receptor modulators

Usage of Osphena

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.

Osphena side effects

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.

    Before taking Osphena

    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.

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    How to use Osphena

    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.

    Warnings

    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.

    What other drugs will affect Osphena

    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.

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