
Osphena
Osphena (ospemifene) is used to treat vaginal dryness and painful sex in people who have gone through menopause. It belongs to a drug class called selective estrogen receptor modulators (SERMs). Osphena (ospemifene) comes as a tablet that's taken by mouth. The typical dosage is one tablet once a day. Side effects can include hot flashes and vaginal discharge.
What is Osphena (ospemifene)?
What is Osphena (ospemifene) used for?
- Painful sex caused by menopause
- Vaginal dryness caused by menopause
How Osphena (ospemifene) works
Osphena (ospemifene) is a selective estrogen receptor modulator, or SERM for short. It acts like estrogen in your vagina. Estrogen is a hormone that helps keep your vagina moist and healthy.
During menopause, your body makes less estrogen. This can cause vaginal dryness and make sex painful. Osphena (ospemifene) helps relieve these symptoms by acting like estrogen.
Drug facts
| Common Brands | Osphena |
|---|---|
| Drug Class | Selective estrogen receptor modulator (SERM) |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Osphena (ospemifene) essentials
Side effects of Osphena (ospemifene)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Hot flashes (12%)
- Vaginal discharge (6%)
- Muscle spasms (5%)
Less Common Side Effects
- Headaches
- Excessive sweating
- Night sweats
- Vaginal bleeding
Osphena (ospemifene) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clot in the leg: swelling, pain, or tenderness in the leg; skin that's warm to the touch
- Blood clot in the lung: trouble breathing, chest pain
- Heart attack: chest pain, arm pain, shortness of breath, cold sweat, lightheadedness
- Stroke: sudden weakness on one side of the body, a drooping face, trouble speaking or walking, vision changes, confusion, severe headache
- Abnormal vaginal bleeding that doesn't go away or keeps happening
The following Osphena (ospemifene) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
Vaginal bleeding
Incidence not known
change in vaginal discharge
dizziness or lightheadedness
fainting
fast heartbeat
hoarseness
irritation
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
pain or feeling of pressure in the pelvis
pain, redness, or swelling in the arm or leg
redness of the skin
swelling of the eyelids, face, lips, hands, or feet
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
tightness in the chest
troubled breathing or swallowing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Feeling of warmth
redness of the face, neck, arms, and occasionally, upper chest
sudden sweating
white or brownish vaginal discharge
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Osphena (ospemifene)
Pros
- Taken by mouth just once a day
- Can help with both vaginal dryness and painful sex after menopause
Cons
- Can cause bothersome hot flashes
- Might take a few weeks to notice improvement
Pharmacist tips for Osphena (ospemifene)
- Take Osphena (ospemifene) once a day with food. Food helps your body absorb the medication better.
- Osphena (ospemifene) can cause hot flashes, vaginal discharge, and sweating. These side effects are usually mild but can be bothersome. To help with hot flashes, try keeping rooms cool or using a fan. You can also try limiting spicy foods, alcohol, and caffeine if they make your hot flashes worse. Tell your care team if any side effects bother you too much or don't go away.
- Don't take Osphena (ospemifene) with other estrogen medications. It's not known if taking them together is safe. If you need more help with menopause symptoms, talk to your prescriber about your options.
- Tell your prescriber and pharmacist about all the medications you take. Some medications, like fluconazole (Diflucan) and rifampin, shouldn't be taken with Osphena (ospemifene). Fluconazole can raise your risk of side effects from Osphena (ospemifene). And, rifampin can make Osphena (ospemifene) work less well. Your care team can check if your medications are safe to take together.
- Tell your prescriber if you have surgery planned or expect to be on bed rest. These situations can raise your risk of blood clots. Your prescriber might ask you to stop Osphena (ospemifene) at least 4 to 6 weeks before certain surgeries or bed rest. Ask when it's safe to start Osphena (ospemifene) again.
Risks and warnings for Osphena (ospemifene)
Osphena (ospemifene) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for blood clots, stroke, or heart attack
- Risk factors: Personal or family history of blood clots | High blood pressure | High blood sugar (diabetes) | High cholesterol | Systemic lupus erythematosus (SLE) | Identify as obese | Tobacco use
In rare cases, people taking Osphena (ospemifene) have had serious blood clots, heart attacks, or strokes. Tell your prescriber about your medical history before starting this medication. They can check your risk for these problems.
Know the warning signs of blood clots, heart attacks, and strokes:
-
Blood clot in the leg: pain, swelling, or tenderness in the leg
-
Blood clot in the lung: chest pain, trouble breathing
-
Heart attack: chest pain, arm pain, shortness of breath, cold sweats, lightheadedness
-
Stroke: sudden weakness on one side of the body, a drooping face, trouble speaking, sudden vision changes, severe headache
Stop taking Osphena (ospemifene) and get medical help right away if you notice any of these symptoms.
Risk of endometrial (uterine) cancer
Osphena (ospemifene) acts like estrogen in your uterus. It cause the lining of your uterus to get thicker. Too much growth of this lining can raise the risk of endometrial cancer, a type of cancer in the uterus.
In studies, some people taking Osphena (ospemifene) had a thicker uterine lining. But no cases of endometrial cancer were reported during studies lasting up to 1 year. It's not known if taking another hormone called progestin with Osphena (ospemifene) can help lower this risk.
Tell your care team right away if you have any unusual vaginal bleeding, especially if it doesn't go away or keeps coming back. This could be a warning sign of endometrial cancer.
Breast cancer precautions
- Risk factors: Currently have or have had breast cancer
Osphena (ospemifene) hasn't been well studied in people with breast cancer. It's not known if it can affect your risk of this cancer. To be safe, you shouldn't take Osphena (ospemifene) if you have breast cancer, have had it in the past, or might have it.
Get regular mammograms and do self-exams as recommended by your prescriber. Check your breasts for any unusual changes, and tell your care team if you notice anything different.
Osphena (ospemifene) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 60mg | 90 tablets | $205.20 | $2.28 |
Interactions between Osphena (ospemifene) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Amiodarone
- Ceritinib
- Clarithromycin
- Eslicarbazepine Acetate
- Fluconazole
- Fluvoxamine
- Ketoconazole
- Piperaquine
- Regorafenib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amobarbital
- Aprobarbital
- Bosentan
- Butabarbital
- Butalbital
- Carbamazepine
- Dexamethasone
- Efavirenz
- Enzalutamide
- Etravirine
- Fosphenytoin
- Mephobarbital
- Methohexital
- Modafinil
- Nafcillin
- Nevirapine
- Oxcarbazepine
- Pentobarbital
- Phenobarbital
- Phenytoin
- Prednisone
- Primidone
- Rifabutin
- Rifampin
- Rifapentine
- Secobarbital
- St John's Wort
- Thiopental
How much does Osphena (ospemifene) cost?
$205.20
Osphena (ospemifene) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Osphena (ospemifene) will not be safe for you to take.
- Abnormal vaginal bleeding
- Estrogen-dependent cancers or tumors
- Currently have or have had a blood clot (deep vein thrombosis or pulmonary embolism)
- Currently have or have had a stroke or heart attack
- Currently pregnant or can become pregnant
What are alternatives to Osphena (ospemifene)?
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