Osphena

Osphena (ospemifene) is a selective estrogen receptor modulator, abbreviated SERM. This drug mimics estrogen in your vaginal tissue. Estrogen helps to moisturise the vaginal lining. During menopause, your estrogen levels decrease, causing your vagina to dry and itch. This can make sex painful and unpleasant. By acting like estrogen, Osphena reduces vaginal dryness and painful sex.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Osphena. However, the following is a synopsis of the general guidelines for the use of Osphena:

• Take this medication with food.
• Osphena may increase your chances of getting a condition that can progress to uterine cancer. To help reduce this risk, your doctor may recommend that you take a progestin. If you see any odd vaginal bleeding, report it right away.
• Your doctor should monitor your development on a regular basis to determine if you should continue receiving this treatment. Self-examine your breasts for lumps once a month, and undergo regular pelvic exams and mammograms while taking Osphena.
• If you need significant surgery or will be on long-term bed rest, you may need to discontinue this medication for a brief period of time. Any doctor or surgeon who treats you should be aware that you are on Osphena.

The most common side effects of Osphena seen in clinical trials as compared to placebo include:

• Hot flashes.
• Vaginal discharge.
• Muscle spasms.
• Headaches.
• Excessive sweating (hyperhidrosis).
• Vaginal bleeding.
• Night sweats.

Some individuals may experience serious side effects while using Osphena. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Symptoms of a blood clot in the arm or leg include swelling, discomfort, or soreness, as well as heated skin.
• A blood clot in the lung causes difficulty breathing and chest pain.
• Heart attack symptoms include chest discomfort, arm pain, shortness of breath, cold sweat, and lightheadedness.
• Stroke symptoms include sudden weakness on one side of the body, drooping facial muscles, abnormalities in speech or vision, confusion, and a severe headache.
• Allergic reactions such as hives, skin rash, or swelling.
• Unusual vaginal bleeding that does not go away.

These are not all of the possible side effects of ospemifene. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Osphena, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• History of a heart attack, stroke, or blood clots.
• Abnormal genital bleeding.
• Type of cancer, such as breast cancer, uterine cancer, endometrial cancer, or hormone-dependent cancer.
• Liver disease.
• History of, or active arterial thromboembolic disease (eg, stroke, MI).
• Heart disease.
• High blood pressure.
• High cholesterol.
• Diabetes.

Boxed Warning

The use of unopposed estrogens in women with uteruses can cause an increased risk of endometrial cancer due to estrogen's agonistic effects on the endometrium. To rule out malignancy, postmenopausal women with unexplained or chronic abnormal vaginal bleeding should receive appropriate diagnostic tests, including an endometrial sample as needed.

Ospemifene has also been associated with cardiovascular risks. In clinical trials, therapy increased the incidence of thromboembolic and hemorrhagic strokes compared to placebo, and both groups reported cases of deep vein thrombosis (DVT), but at somewhat different rates.

• Abnormal vaginal bleeding.
• Estrogen-dependent neoplasia (tumors or cancer).
• A blood clot (venous thromboembolism) is currently present or has already occurred, including a deep vein thrombosis/pulmonary embolism.
• Have suffered a stroke or heart attack.
• Currently pregnant or may become pregnant.
• Hypersensitivity to ospemifene or any of the inactive ingredients in the formulation.

Some people who received Osphena (ospemifene) in a clinical study reported relief in vaginal dryness and uncomfortable sex symptoms as soon as one month into treatment. Keep in mind that most participants in the study required up to three months of treatment to see any benefit. Check in with your prescriber regularly to see how well Osphena (ospemifene) is treating your symptoms.

When Osphena is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Bazedoxifene.
• Clomiphene.
• Fluconazole.
• Ketoconazole.
• Rifampin.
• Tamoxifen.
• Toremifene.
• Birth control pills.
• Hormone replacement therapy.

Osphena is available in the following dosage form and strength: 60 mg tablet.

The typical dose is 60 mg by mouth once daily with food.

Store at room temperature and keep out of reach of children.

Duchesnay USA, Inc. is the company that manufactures Osphena.

There are no lower-cost generic versions available of Osphena.

Talk to your doctor if you are having untolerable side effects or want to stop taking Osphena (ospemifene). They can recommend what is best for you.

Osphena is contraindicated in women who are or may become pregnant. If you become pregnant while taking this medication, notify your doctor immediately.

It is not known if Osphena is found in breast milk. You should not breastfeed when taking this medication.