Osphena

Generic Name: ospemifene (os PEM i feen)
Brand Names: Osphena

What is Osphena?

Osphena (ospemifene) is a non-estrogen medication that reverses certain changes in vaginal tissue that are caused by menopause.

Osphena is used to relieve pain during sexual intercourse in menopausal women. Ospemifene is not a pain medication.

Osphena may also be used for purposes not listed in this medication guide.

Important information

Do not use Osphena if you are pregnant, or may become pregnant.

You should not use this medication if you have unusual vaginal bleeding, breast or uterine cancer, or a history of heart attack, stroke, or blood clot.

Slideshow: Flashback: FDA Drug Approvals 2013

Osphena may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Report any unusual vaginal bleeding to your doctor right away.

Osphena may also increase your risk of a stroke or blood clot. Talk with your doctor about your individual risks.

Before taking this medicine

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.

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

  • liver disease;

  • a history of breast cancer; or

  • risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol).

Osphena may increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. If your uterus has not been removed, your doctor may prescribe a progestin for you to take to lower this risk while you are taking this medicine.

Osphena may also increase your risk of a stroke or blood clot. Talk with your doctor about your individual risks.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use Osphena if you are pregnant or may become pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are taking this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

It is not known whether ospemifene passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Osphena?

Osphena is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take with food.

Report any unusual vaginal bleeding to your doctor right away.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis while taking Osphena.

If you need surgery or if you will be on bed rest, you may need to stop taking this medication for a short time. Any doctor or surgeon who treats you should know that you are taking Osphena.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

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

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:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs; or

  • any unusual vaginal bleeding.

Common Osphena side effects may include:

  • hot flashes;

  • vaginal discharge;

  • increased sweating; 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.

See also: Side effects (in more detail)

Osphena dosing information

Usual Adult Dose for Dyspareunia:

Moderate to severe: 60 mg once daily

Duration of therapy: Shortest duration necessary to treat symptoms and prevent risks

Comments: Take with food

What other drugs will affect Osphena?

You should not use Osphena together with estrogens, such as birth control pills or hormone replacement medications.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine, especially:

  • fluconazole.

This list is not complete. Other drugs may interact with ospemifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Osphena.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Osphena only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.02. Revision Date: 2013-08-15, 8:11:19 AM.

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