Osphena (ospemifene) is a medication used to treat symptoms of painful intercourse and vaginal dryness for women in menopause. It is a non-hormonal oral treatment taken once daily. While it may be an effective treatment for some, it does come with risks and may not be right for everyone with these conditions.
What Is Osphena (Ospemifine)?
Osphena is a prescription medication with the active ingredient ospemifene. It is designed for postmenopausal women, helping with issues like painful intercourse and vaginal dryness. It falls into the estrogen agonist/antagonist category, working on estrogen receptors in the body.1
Currently, there isn’t a generic version of Osphena available in the United States. It remains a prescription-only solution, offering specific relief for menopausal symptoms that can affect women’s well-being.
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How Does Osphena Work?
Osphena (ospemifene) is thought to work by interacting with estrogen receptors in the body. By influencing estrogen’s effects, helping them function more like they did before menopause. Osphena’s effects on estrogen receptors help ease issues such as painful intercourse and vaginal dryness that commonly occur during menopause.
How Long Does it Take for Osphena to Work?
When taking Osphena daily, it typically takes about a month to start noticing symptom improvement. During this time, if needed, you can still use non-medicated vaginal lubricants and moisturizers to help alleviate symptoms while waiting for the full benefits of Osphena to take effect. Take your medication consistently to maximize its effectiveness, even when you don’t feel symptom improvement right away. If you don’t see improvement for several weeks, it may help to speak to your prescriber for guidance.
What Is Osphena Used to Treat?
Osphena is FDA-approved for the treatment of severe vaginal dryness and dyspareunia (severely painful intercourse). FDA approval signifies that rigorous scientific evaluations have been conducted to confirm the medication’s safety and effectiveness for these specific uses.
By addressing these symptoms, Osphena aims to enhance the overall quality of life for postmenopausal women, promoting comfort and well-being with their sexual health.
How Effective is Osphena?
Osphena has proven to be highly effective in addressing discomfort during intercourse and vaginal dryness in postmenopausal women. It received FDA approval in 2013 as the first non-hormonal option for this purpose.
Studies show significant improvement in vaginal health and relief from symptoms. Osphena’s safety profile is reassuring, with mild hot flashes being the most common side effect. Overall, it’s considered a safe and effective alternative to estrogen-based treatments for postmenopausal symptoms.2
Osphena Warnings & Precautions
When considering Osphena for managing menopausal symptoms, it’s crucial to be aware of potential warnings. If you have a history or risk of blood clots, breast cancer, or liver issues, caution is advised. These conditions may require special attention. Consult with your healthcare provider to discuss potential risks and find the most suitable approach for managing menopausal symptoms safely.
You may need to avoid or take precautions with Osphena if you:1
- Have venous thromboembolism: Osphena should be avoided by individuals with a history or risk of blood clots in veins, as it may increase the risk of developing conditions like deep vein thrombosis (DVT) or pulmonary embolism.
- Experience allergic reactions: If you’ve had allergic reactions to Osphena or its components in the past, it’s crucial to avoid its use to prevent potential allergic responses, which can vary in severity and may pose risks to your health.
- Have a history of breast cancer: Individuals with a known history of breast cancer should avoid Osphena due to potential risks. The medication might not be suitable and could potentially interfere with ongoing treatment or increase the risk of recurrence.
- Are pregnant or breastfeeding: Osphena is not recommended for use during pregnancy or while breastfeeding as it may pose risks to the developing fetus or nursing infant. Seeking alternative treatments or discussing options with a healthcare provider is advised in these situations.
Side Effects of Osphena
Like all medications, Osphena has the potential to cause side effects for some individuals. Temporary effects may occur while the body is adjusting to the medication, such as headaches, excessive sweating, vaginal hemorrhage, and night sweats. Side effects may occur due to the chemical action of the medication and may persist for as long as a person takes it. While uncommon, some may experience serious side effects that need immediate medical attention.
Common Side Effects of Osphena
Common side effects of Osphena may occur for some who take it, ranging from mild to severe. Talk to your doctor for ways to treat and manage these effects if they become bothersome.
Common side effects of Osphena include:1
- Hot flushes
- Vaginal discharge
- Muscle spasms
- Headaches
- Excessive sweating
- Vaginal hemorrhage
- Night sweats
*All medications, including Osphena, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Serious Side Effects of Osphena
Serious side effects of Osphena require immediate medical attention and are detailed elsewhere in the labeling. These serious effects may increase risks for heart health and malignant growths.
Serious side effects of Osphena include:1
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden severe headaches
- Chest pain
- Leg pain with or without shortness of breath, weakness, and fatigue
*All medications, including Osphena, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
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What to Avoid When Taking Osphena
When taking Osphena, be cautious about mixing it with other medications, substances, or herbs, as it can affect how Osphena works in your body. Don’t use it with estrogens or estrogen-related drugs, as the safety of this combination is unknown. Certain medications, like fluconazole and rifampin, can either boost or reduce Osphena’s effectiveness.
5 substances you should avoid while taking Osphena include:
- Estrogens and estrogen agonists/antagonists: Combining Osphena with these substances hasn’t been studied, and their interaction may have unpredictable effects.
- Fluconazole: When taken with Osphena, this antifungal medication can amplify Osphena’s effects, which may increase the chance of experiencing side effects.
- Rifampin: This antibiotic is often used to treat or prevent tuberculosis. It can weaken Osphena’s effectiveness, meaning Osphena might not work as it should.
- Ketoconazole: This antifungal medication is similar to fluconazole, meaning that it can also increase the effects of Osphena and the likelihood of adverse reactions.
- Highly protein-bound drugs: Like Osphena, these medications attach to proteins in the blood. Taking these with Opshena could lead to interference with how either medication works, possibly increasing side effects.
Osphena Dosages for FDA-Approved Treatment
Osphena dosages vary for individuals based on factors like age and the specific condition being treated. The standard dose is one tablet containing 60 mg of Osphena. The severity of symptoms doesn’t determine dosage; healthcare providers consider individual patient characteristics.
Osphena Forms & Strengths
Osphena is available in tablet form, with each tablet containing 60 mg of Psphena. The choice of the appropriate form and strength is determined by healthcare providers based on individual factors such as age and overall health. Osphena is provided in a standard tablet form without extended or delayed-release variations. Dosages may vary, and individuals should follow their healthcare provider’s instructions for optimal results.
Osphena is available in the following forms and strengths:
- 60 milligrams (mg) oral tablet
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How Should I Take Osphena?
Follow your healthcare provider’s instructions for taking Osphena. This medication is most effective when taken consistently and as directed. For the treatment of moderate to severe dyspareunia or vaginal dryness due to menopause, the typical dosage involves taking one 60 mg tablet with food once daily. Taking Osphena with food is recommended.
What Happens If I Miss a Dose of Osphena?
If you miss a dose of Osphena, take it as soon as you remember, but skip it if it’s almost time for your next scheduled dose. It’s crucial not to double up on doses to make up for a missed one. Abruptly stopping or altering the prescribed dosage can impact the effectiveness of the treatment.
If you have missed a dose and aren’t sure if you should take it, contact your pharmacist or healthcare professional.
Can You Overdose on Osphena?
While it’s uncommon, an overdose of Osphena can occur. Signs and symptoms of an overdose may include nausea, vomiting, dizziness, and excessive sweating. If someone has taken an excessive amount of Osphena and experiences severe symptoms like difficulty breathing or loss of consciousness, seek immediate medical attention.
What Should You Do If You Take Too Much Osphena?
If you take too much Osphena and experience symptoms such as severe nausea, vomiting, dizziness, or difficulty breathing, seek immediate medical attention. Contact your local emergency services or call 911. Do not attempt to manage the situation on your own. Tell emergency providers what medication you have taken and how much.
Frequently Asked Questions
How Long Can You Use Osphena For?
The duration of Osphena use should be determined based on individual treatment goals and risks. Clinical guidance suggests that postmenopausal women should be periodically re-evaluated to assess the ongoing need for Osphena treatment. Always consult with your healthcare provider for personalized advice and to discuss the most appropriate duration of Osphena use..
Is Osphena a Hormone Replacement?
Osphena is not a hormone replacement therapy. It is classified as a selective estrogen receptor modulator (SERM) and is the first non-hormonal agent approved for treating dyspareunia. This condition is persistent or recurrent genital pain that occurs just before, during, or after sex, associated with changes to the vagina after menopause.3
Unlike traditional hormone replacement therapies, which provide estrogen, Osphena works by affecting estrogen receptors in specific tissues. This unique mechanism of action distinguishes it from hormone replacement therapies, making it a valuable alternative for postmenopausal women experiencing vaginal symptoms.
Can Osphena Help Improve Bone Mineral Density?
Evidence suggests that it might have positive effects on bone mineral density, similar to other medications like raloxifene. While originally designed for vaginal symptoms, Osphena’s unique properties make it potentially advantageous for both intimate health and bone strength. However, it’s important to consult with your healthcare provider to understand the specific benefits and considerations tailored to your situation.3
Is Osphena Safer Than Estrogen?
Compared to estrogen-based therapies, which have been associated with certain health risks, including cardiovascular events, Osphena has demonstrated a good safety profile in clinical trials. As with any medication, individual health considerations should be discussed with a healthcare provider to determine the most suitable and safe option tailored to the patient’s specific needs.
Does Osphena Affect Fertility?
Osphena is designed for postmenopausal women and is not intended for individuals of reproductive age. As such, its impact on fertility is not a relevant consideration. If you have concerns about fertility or family planning, consult with your healthcare provider for personalized advice.
Questions to Ask Your Healthcare Provider About Osphena
If you’re experiencing menopausal symptoms like dyspareunia or vaginal dryness, ask your healthcare provider about Osphena. Inquire about its benefits, potential side effects, and any interactions with mental health medications if under the care of a psychiatrist. Online psychiatry services can be a convenient option when changing prescribers while addressing menopausal symptoms with a new provider.
Questions to ask your care team about Osphena include:
- How safe is Osphena, and are there common side effects I should be aware of?
- How long does it typically take for individuals to adjust to taking Osphena?
- If I’m currently on other medications, does taking Osphena pose any additional risks or interactions?
- What is the recommended dosage to minimize potential side effects while effectively addressing my symptoms?
- Are there any lifestyle changes or precautions I should consider while taking Osphena?
- Can Osphena be used in conjunction with other treatments or therapies for menopausal symptoms?
- What steps should I take if I miss a dose of Osphena?
- Are there specific health conditions that may contraindicate the use of Osphena?
- How often should I follow up with my care team to assess the effectiveness of Osphena for my symptoms?
- Is there a specific age range for individuals for whom Osphena is most suitable?
- Can I take Osphena if I have a history of breast cancer or other gynecological conditions?
- Are there alternative treatments or therapies that I should be aware of, and how does Osphena compare to them in terms of effectiveness and safety?
- Is dyspareunia a sexual disorder?
In My Experience
In my experience, talking about Osphena with your healthcare provider is vital for managing symptoms of menopause effectively. Those who find Osphena beneficial have reported substantial relief from discomfort. However, it’s important to acknowledge potential challenges, such as the potential side effects, interactions, and the cost of Osphena. Understanding your treatment options for severe vaginal pain and dryness can help you manage your symptoms effectively.
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