Osphena (Ospemifene) - Oral

What Is Osphena?

Osphena is a medication option to relieve vaginal and sexual-related symptoms of menopause. Symptoms may include vaginal dryness and pain during sex.

Osphena is an estrogen agonist/antagonist, also known as a selective estrogen receptor modulator (SERM). This medication attaches to estrogen receptors (binding sites). In certain tissues, Osphena will promote estrogen-related pathways. In other tissues, however, Osphena may block estrogen-related pathways. So, Osphena's estrogen effects are tissue-specific.

Osphena is available as a prescription tablet. The Food and Drug Administration (FDA) has a black box warning of an increased risk of blood clots and stroke for Osphena. Osphena may also raise the likelihood of endometrial (uterine lining) cancer. This risk is high in people being female at birth who haven't had a hysterectomy (procedure to remove the uterus).

What Is Osphena Used For?

Osphena is a medication option used to relieve vaginal and sexual-related symptoms of menopause.

For people assigned female at birth, menopause is an ordinary part of life. Menopause is a complete stop of your menstrual cycles and periods. The average age for people assigned female at birth to experience menopause is 52.

With menopause being a normal part of life, symptoms might go away without treatment. Some people, however, may have vaginal and sexual-related symptoms, which are causes of discomfort. A few of these symptoms may include vaginal dryness and pain during sex. Osphena may help with these symptoms.

How to Take Osphena

Take Osphena by mouth once daily with food.

Storage

When you bring Osphena home from the pharmacy, store the medication at room temperature between 68 degrees to 77 degrees Fahrenheit (F). Osphena also has a short-term safety storage range between 59 degrees to 86 degrees F.

To be safe, you may also place Osphena in a locked cabinet or closet to keep your medication out of reach of children and pets.

If you plan to travel with Osphena, get familiar with your final destination's regulations. In general, be sure to make a copy of your Osphena prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

Visit the FDA's website to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area. If you have any questions about the best ways to dispose of your medications, ask your pharmacist or healthcare provider.

Off-Label Uses

Currently, Osphena has no off-label uses.

What Are the Side Effects of Osphena?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Osphena may include:

• Excessive sweating
• Headaches
• Hot flashes
• Muscle spasms
• Night sweats
• Vaginal discharge
• Vaginal bleeding
  

Severe Side Effects

Serious side effects and their symptoms include:

• Severe allergic reaction: If you have a severe allergic reaction to Osphena or any of its ingredients, symptoms may include swelling, rash, and itchiness.
• Blood clots: Osphena may increase your risk of blood clots. If you're having blood clots, you might experience breathing difficulties, weakness, and lack of energy. You may also have pain in your legs or chest.
• Stroke: Taking Osphena may raise your risk of having a stroke. If you're experiencing a stroke, you might notice vision or speech changes. You may also have a sudden and severe headache.
• Cancer: If you still have your uterus, Osphena—without progestin (a human-made version of the progesterone sex hormone)—may raise the likelihood of endometrial (uterine lining) cancer. An endometrial cancer symptom may include abnormal vaginal bleeding.
  

Contact your healthcare provider right away if you develop any of these severe side effects. Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

Long-term use of Osphena is linked to the following possible side effects:

• Blood clots
• Stroke
• Cancer
  

Dosage: How Much Osphena Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Osphena:

Severe allergic reaction: If you have a severe allergic reaction to Osphena, your healthcare provider is unlikely to recommend this medication for you.

Pregnancy: In animal studies, Osphena was found to have adverse effects on the fetus. As a result, Osphena isn't recommended for pregnant people. If you have questions or concerns, talk with your healthcare provider. They will help you weigh the benefits and risks of taking Osphena during your pregnancy.

Breastfeeding: In animal studies, Osphena is present in rat breast milk. There is no information about the effects and safety of Osphena in nursing babies. Therefore, Osphena isn't typically recommended for nursing parents. If you have questions or concerns, talk with your healthcare provider. Your healthcare provider will help you weigh the benefits and harms of taking Osphena while breastfeeding. They can also discuss the different ways available to feed your baby.

Adults over 65: Osphena has no effectiveness and safety differences between older and younger adults.

Children: There are no studies for Osphena in children. Use is not recommended.

Liver problems: Osphena hasn't been studied in people with severe liver impairment. As a result, Osphena isn't recommended for people with severe liver impairment.

Blood clots or stroke: If you develop blood clots or stroke while taking Osphena, your healthcare provider will stop the medication as soon as possible.

Missed Dose

If you accidentally forgot your Osphena dose, take it as soon as you remember. If it's already close to your next scheduled dose, however, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways to help yourself remember to routinely take your medication that works for you. If you miss too many doses, Osphena might be less effective at relieving your menopausal symptoms.

Your healthcare provider will regularly assess the need to continue taking Osphena. When the risks of Osphena outweigh its benefits, your healthcare provider will have an open conversation with you about slowly stopping Osphena.

Overdose: What Happens If I Take Too Much Osphena?

There is limited information available about Osphena overdose.

If you think that you're experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Osphena?

Before taking Osphena, talk with your healthcare provider if any of the following applies to you:

• Severe allergic reaction: If you have a severe allergic reaction to Osphena or any of its components (ingredients), then Osphena isn't a good option for you.
• Pregnant or nursing parents: There is little information about the effects and safety of Osphena on the unborn fetus and nursing baby. As a result, Osphena isn't recommended for pregnant or nursing people.
• Children: There are no safety and effectiveness studies for Osphena in children. Use is not recommended.
• Adults over 65: Osphena has no effectiveness and safety differences between older and younger adults.
• Liver problems: If you have severe liver impairment, Osphena isn't recommended for you.
• Abnormal vaginal bleeding: If you have abnormal vaginal bleeding, this might be a symptom of endometrial (uterine lining) cancer. Your healthcare provider will need to rule out this cancer before starting you on Osphena.
• Cancer: If you have a type of cancer that depends on estrogen, Osphena isn't recommended.
• Blood clots, stroke, heart attack: Osphena isn't a viable option for you if you actively have or previously had blood clots, strokes, or heart attacks.

What Other Medications Interact With Osphena?

In general, don't use Osphena with other estrogens—like estradiol—or selective estrogen receptor modulators (SERMs)—like Evista (raloxifene). Osphena hasn't been studied with other estrogen or SERM products.

Also, use caution with medications that affect the following cytochrome P450 (CYP450) proteins: CY3A4, CYP2C9, and CYP2C19. These proteins are located in the liver. They're responsible for breaking down medications, such as Osphena.

Medications—like the fluconazole antifungal—that inhibit all of these proteins will lead to a build-up of Osphena in the body. This will increase the risk of side effects. Medications—like rifampin for tuberculosis (TB), on the other hand, encourage all of these proteins to quickly break down Osphena. With low amounts of Osphena in the body, the medication will also be less effective.

These are some key drug interactions for Osphena. This isn't a complete list. For more detailed information about medication interactions with Osphena, talk with your pharmacist or healthcare provider.

And be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

There are a number of different treatment options for your menopausal symptoms. Osphena is a selective estrogen receptor modulator (SERM) that's used for menopausal symptoms. Other SERMs that may also relieve menopausal-related symptoms include Evista (raloxifene) and Duavee (conjugated estrogens and bazedoxifene).

Compared to all available SERMs for menopausal-related symptoms, Evista is the only choice that has a generic option. It's also the only SERM that's used to reduce breast cancer risk in postmenopausal people assigned female at birth. Evista may also help prevent osteoporosis (bone loss) in this same population. Evista, however, is better at decreasing the risk of vertebral (spinal) fractures (breaks) than other non-vertebral (non-spinal) fractures.

Similar to Evista, the SERM component (e.g., bazedoxifene) of Duavee is used to prevent osteoporosis in postmenopausal people assigned female at birth. Unlike Evista, however, Duavee may lower the risk for both spinal and non-spinal fractures. Duavee is different from the other two SERMS due to its ability to relieve systemic (whole-body) menopausal symptoms, such as hot flashes, mood swings, sleeping troubles, and low libido (sex drive).

Compared to Evista and Duavee, Osphena isn't FDA-approved to prevent osteoporosis. Similar to Duavee, Osphena is used for menopausal symptoms. Osphena, however, is only used for vagina-specific symptoms—not whole-body symptoms.

Since all of these medications are SERMs, taking them together isn't recommended.

How Can I Stay Healthy While Taking Osphena?

If you're taking Osphena, chances are vaginal-specific menopausal symptoms have been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with menopause does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:

• Take menopause-related medications as recommended by your healthcare provider.
• Stay in touch with your healthcare provider. They will regularly assess the need to continue taking Osphena. When the risks outweigh the benefits, they will help you slowly stop Osphena.
• Consider exercise to help you reduce stress, limit weight gain, and prevent osteoporosis (bone loss).
• Perform Kegel exercises to improve bladder control and prevent urine (pee) leakage issues.
• Consider OTC vaginal lubricants or moisturizers to relieve vagina and sexual-related symptoms of menopause.
• To decrease the severity and duration of your hot flashes, consider dressing in fewer layers, adjusting the temperature, avoiding hot environments, and slowly taking deep breaths.
• Drinking adequate amounts of water and avoiding hot or spicy food may also help with your hot flashes.
• Use memory aids (e.g., bulletin boards), develop a routine, or write things down to minimize forgetfulness.
• Consider support groups or a mental health professional to help you find coping strategies that change the way you think, feel, react, or respond to living with menopause.