Ospemifene (Oral)

Delivered in tablet form, Ospemifene is typically prescribed for women who experience painful intercourse (known as dyspareunia) from the menopause.

Overview

By acting like natural estrogen on the female body, oral Ospemifene is used in the treatment of women with significant (moderate to severe) dyspareunia caused by menopause. In menopause, lowered levels of estrogen lead to changes to the vagina which can include dryness and receding tissue (known as atrophy).

Ospemifene belongs to a group of medicines known as selective estrogen receptor modulators (SERM). Ospemifene works differently to hormone therapies, including drugs containing estrogens and progestins. Available only on prescription from a qualified physician, it mimics the action of estrogen in specific parts of the body.

Conditions Treated

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    • Moderate to severe dyspareunia (painful intercourse)

Type Of Medicine

    • Selective estrogen receptor modulator (SERM)

Side Effects

All medicines come with the risk of causing undesired or harmful side effects alongside their required functions. Not all the following side effects may occur, but they may sometimes require medical attention.

Patients who experience any of the following side effects should contact their physician immediately for medical advice:

    • Pressure or pain sensations in the pelvic area
    • Bleeding from the vagina
    • Changes in vaginal discharge
    • Sudden cough
    • Anxiety
    • Fast or pounding heart beat
    • Difficulty speaking
    • Slowed or slurred speech
    • Breathing difficulties or shortness of breath
    • Nausea or vomiting
    • Unusual excessive sweating
    • Double vision
    • Confusion or hallucinations
    • Inability to move the face, legs or arms
    • Swelling in the limbs
    • Redness or pain in the legs or arms
    • Pain in the back, neck, jaw or arms
    • Tightness or discomfort in the chest.

Other side effects may present themselves in some patients that do not require immediate medical attention. The following side effects may disappear over the course of treatment as a patient's body adapts to the effects of the medicine. Patients should be encouraged to seek medical advice from their physician or pharmacist if their side effects become persistent or particularly worrisome. A physician or pharmacist should be able to provide advice on how to reduce or prevent these side effects, as well as answer any questions about the course of treatment.

    • Increased excessive sweating
    • Spasming muscles
    • Warming sensations
    • Brown or white-colored vaginal discharge
    • Facial redness, or redness on the neck, upper chest or arms.

A small number of patients may also experience side effects not listed here. They should seek medical advice to find out more. New side effects can also be reported to the FDA by calling 1-800-FDA-1088.

Dosage

Different patients will require different doses, depending on the nature of their condition, age and medical history, and the specific strength of the formulation of Ospemifene. Patients should always follow the directions given by their physician or the instructions on the label. Typical dosing instructions are given below, but some patients may be prescribed a different dose. They should not alter their dose without first speaking to their physician.

Patients should closely follow their physician's advice on the number of times they should take Ospemifene a day, the timings between each dose, and the overall length of treatment.

Typical dosage instructions for oral Ospemifene (tablets) to treat dyspareunia in adults are 60 milligrams, taken once a day. Ospemifene is not recommended for use in children (pediatric care).

If a patient misses a dose of Ospemifene, they should take it as soon as they realize their error. However, if it is nearly time for their next dose, they should miss out the missed dose and take their next one as usual. Patients should not double dose.

Major drug interactions

Drug interactions can increase a patient's risk of experiencing more serious side effects or alter the effects of their medications. The following list of drug interactions is not exhaustive. Patients should tell their physicians about all medicines and substances they are taking, including over the counter medicines, herbal remedies and narcotics. They should not change the dose, or stop or start taking Ospemifene unless under their physician's instruction.

Estrogen medicines present major drug interactions with Ospemifene. Other drugs may impede the action of Ospemifene or change the way it is removed from the body, which can lead to undesired side effects. These include rifampin and fluconazole.

The following medicines may cause serious harm if they interact with Ospemifene. Patients who are concerned and are taking any of the following should contact their physician immediately for advice.

    • Fluconazole
    • Voriconazole

The following medicines may cause moderate interactions when taken with Ospemifene. Patients should speak to their physician or pharmacist to find out more.

    • Some specific types of CYP2C and CYP3A4 inducers

Warnings

A physician should regularly check the patient's progress while taking Ospemifene to ensure the medicine is working correctly and to review whether ongoing treatment is necessary.

Women taking Ospemifene are likely to be postmenopausal, so pregnancy should be unlikely. Patients should still be informed that taking Ospemifene while pregnant poses a significant risk of harm to the unborn baby. Patients who think they may have become pregnant while being treated with Ospemifene should tell a physician as soon as possible.

Using Ospemifene may also raise a patient's risk of developing stroke, heart attacks and blood clots. In patients where these problems are already a significant risk, due to high cholesterol, diabetes, high blood pressure, smoking or obesity, Ospemifene can raise the risk further. Patients should speak to their physician to find out more about these risks before accepting a prescription. If patients taking Ospemifene experience confusion, chest pain, headaches, an inability to move their face, legs or arms, an inability to speak, double vision or speech difficulties, they should seek urgent medical advice.

Taking Ospemifene may also raise the risk of uterine or endometrial cancers, so patients should speak to their physician about ways of reducing this risk. Patients experiencing abnormal bleeding from the vagina should contact their physician immediately.

Patients should fully inform any medical personnel who may be treating them that they are taking Ospemifene (along with any other medicines they are taking) before any other medical treatment. This includes dentists. A medical professional may decide a patient should pause or stop taking Ospemifene completely ahead of surgical procedures, or if they are expected to be bedridden for a prolonged period of time.

Patients are reminded to not take any other medicines unless they have been checked and agreed by their physician. That includes over the counter medicines, prescription medications, herbal remedies, vitamins, supplements, and narcotics.

Ospemifene has been known to increase a patient's risk of developing cancer of the uterus or womb (otherwise known as endometrial cancer). Patients should tell their physician from the outset if they have previously had any kind of cancer, or if they have ever had abnormal bleeding from the vagina. This may result in a physician altering their decision on whether to prescribe Ospemifene. Any patients who experience unusual or new vaginal bleeding while being treated with Ospemifene should contact their physician immediately.

Being treated with Ospemifene also raises the risk of blood clots and strokes. Patients should tell their physician if they smoke, have ever had a blood clot on the lungs or in the legs, suffer from high blood pressure (hypertension), have ever had a stroke, high levels of fat or cholesterol in the blood, lupus (where the body attacks itself, producing swelling and damage), heart disease, or diabetes. This may affect a physician's view on whether to prescribe Ospemifene. If prescribed, patients should regularly see their physician for a review of whether they should be taking Ospemifene.

Patients should ask plenty of questions to understand the benefits and risks of taking Ospemifene when they see their physician.

Storage

Like many medicines, Ospemifene tablets should be stored in a sealed container away from direct sunlight, heat and moisture, at room temperature. It should be kept from freezing and out of the reach of children or vulnerable adults.

Patients should not keep medicines they no longer take or need. Patients should visit their pharmacist or physician to find out how to safely dispose of unwanted, leftover medicines.

Ospemifene should be stored in its original packaging, closed firmly, and out of the reach of children. It should not be stored in the bathroom, where high heats and moisture could cause it to change or degrade.

Patients should be aware that many storage methods for medicines are not child-proof and can enable children to reach their medicines easily, including weekly pill organizers, eye droppers, jars for creams, patch packets and breathing inhalers. To keep children safe from harm, patients should always firmly lock caps and replace the medicine in the same safe location immediately after using. The location should be safely out of the reach and sight of children.

Summary

Oral Ospemifene is provided in tablets for patients to take by mouth, usually with food once a day. Patients should take Ospemifene at the same time every day, and follow the label instructions carefully. If there are any details that the patient does not fully understand, they should contact their physician or pharmacist. Patients should follow the dosage advice carefully and not take more or less than prescribed by their physician.

Ospemifene mimics the action of estrogen on the female body and helps to bring pain during intercourse (which can be caused by changes to the vagina occurring during the menopause) under control. Patients should keep taking Ospemifene, even if they no longer experience pain, until their physician advises otherwise.

Patients will be asked to regularly visit their physician for review so that their doctor can decide whether treatment should continue, and assess the impact of any interactions, side effects and health risks over time. They should also send the patient for a series of examinations at least once a year, including a Pap test (which looks for vaginal cancers), a physical exam, pelvic and breast exams and regular mammograms. Patients should also be advised about checking their own breasts for signs of abnormalities. Patients who detect breast lumps, or experience breast pain or new vaginal bleeding should consult their physician as soon as possible.