Estradiol

Imvexxy

Imvexxy is an FDA-approved drug used for treating moderate to extremely painful sex due to menopause in adult females. Imvexxy is not an over-the-counter medication; you will need a prescription from a healthcare provider to use this drug effectively. Available as vaginal capsules, patients need to be very careful while inserting these capsules vaginally. While Imvexxy has its uses, there can be certain side effects of this medication, which can exacerbate the symptoms. To avoid such situations, stick to the dosage mentioned in your prescription label and administer your medication as instructed by your medical provider. In case your condition does not improve or worsen over time, visit your doctor immediately.         

Imvexxy Overview

Imvexxy is a prescription medication specifically used to alleviate symptoms associated with postmenopausal vulvar and vaginal atrophy (VVA). It contains the active component estradiol, a form of estrogen that helps in treating painful sex in postmenopausal women. This medication is FDA-approved, which ensures the safety and effectiveness of Imvexxy.

Imvexxy is available in the form of soft, bioadhesive vaginal inserts with two dosage strengths: 4 mcg and 10 mcg. It is typically administered daily for the initial two weeks, followed by a maintenance dose as prescribed by a healthcare provider. The inserts are easy to use, offering a convenient and mess-free application directly to the vaginal area. It works by restoring estrogen levels locally, thereby improving the thickness and flexibility of the vaginal walls and easing discomfort associated with VVA.

There are specific side effects of Imvexxy that may include headaches, breast tenderness, and vaginal bleeding. Therefore, patients are advised to follow their healthcare provider’s instructions and report any unusual symptoms promptly. It is important to take Imvexxy as directed, but if a dose is missed, it should be taken as soon as possible. Remember to never take double doses of Imvexxy to make up for a missed dose. In case of an Imvexxy overdose, get immediate medical attention. Besides, the medication should be stored at room temperature, as mentioned in the storage instructions. Keep it away from moisture and heat, and keep it out of reach of children.

Uses of Imvexxy

Imvexxy is a vaginal estrogen therapy that doctors widely prescribe to treat moderate to severe dyspareunia (painful intercourse) post-menopause.

Imvexxy Dosage

Strengths and Forms

It is available as a soft vaginal capsule. There are two strengths of Immvexy, which are as follows:

• 4 mcg, and 
• 10 mcg

Recommended Imvexxy Dosage for Different Patients

For starting and continuing the treatment of postmenopausal symptoms, doctors usually recommend to use the lowest dose for short duration. Patients need to be re-evaluated periodically to determine the progress of the treatment. 

Dosage for Dyspareunia Due to Menopause

• For Adults: Doctors usually start your treatment with 4 mcg of Imvexxy. Use the dose once a day for 2 weeks. Later, your doctor may adjust the dosage to 4 mcg twice weekly (every 3-4 days). If you do not see any improvement, your practitioner will increase the dosage. 
• For Pediatrics (<18 years of age): The use and efficacy are not determined.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take Imvexxy?

• Use your medication as per the instructions given by your medical practitioner.
• Do not exceed or subceed the doses without consulting with a professional, as it can lead to serious complications.
• Imvexxy comes as a soft capsule that you have to insert into your vagina. 
• Wash your hands properly before opening the packaging and inserting the capsule.
• Hold the larger end of the medication in between your thumb and forefinger. 
• Using your finger, insert the soft gel capsule into your vagina, with the smaller end pointing upwards. 
• Make sure to place the medication 2 inches or 5 centimeters into the vagina.
• It is your choice whether you want to do the process while standing or lying down.
• It is only for vaginal use, do not take the medication orally.
• Take your doses at the same time each day for effective results.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Imvexxy Work?

Imvexxy is used in adult women to treat moderate to severe painful intercourse after menopause. This medication contains estradiol, which is a female sex hormone widely known as estrogen. During menopause, the estrogen levels in the female body decline drastically. As a result, many women have to face physical changes in their vagina, also called menopause symptoms, including:

• Vaginal dryness
• Thinning of vaginal walls

Due to these symptoms, some women experience painful sex in their postmenopausal stage. When patients insert Imvexxy vaginal capsules, the medication starts to work by restoring estrogen levels in the vaginal area. This estrogen production helps in reversing the physical changes associated with menopause. However, patients need to understand that Imvexxy is not a lubricant; it just helps in restoring the vaginal’s natural lubrication by treating underlying issues of vaginal dryness.

Imvexxy Side Effects

Common side effects of Imvexxy may include:

• Breast pain/tenderness
• Headache
• Fluid retention (fluid buildup in the body)
• Nausea
• Vomiting
• Feeling bloated
• Tiredness
• Changes in body weight and appetite
• Extreme sweating
• Body odor
• Runny or stuffy nose
• Sore throat
• Cough
• Sinus congestion
• Body aches
• Sneezing
• Changes in menstrual bleeding
• Spotting
• Infrequent periods
• Severe vaginal bleeding

Serious side effects of Imvexxymay include:

• Vision Problems. Its symptoms may include:
  • Eyes bulging
  • Double vision
  • Papilledema (sudden vision loss that may become permanent if not treated timely)
• Blood test result changes. It includes:
  • Increased blood clotting markers
  • Altered thyroid hormone levels
  • High protein levels that bind to the body’s natural corticosteroids and sex hormones
• Gall bladder problems. Signs are:
  • Stomach pain, usually in the mid or upper right area
  • Nausea
  • Vomiting
  • Fever/chills
  • Diarrhea
  • Dark urine
  • Jaundice
• Changes in lipid levels, including cholesterol and triglycerides
• Changes in glucose levels
• Breast or uterine cancer
• Cardiovascular problems. Its symptoms may include:
  • Vision changes
  • Slurred speech
  • Severe chest or leg pain
  • Weakness
  • Difficulty in breathing 
• Dementia. Symptoms are:
  • Mood changes
  • Loss of interest
  • Memory loss
  • Unable to complete tasks that you used to do easily
  • Difficulty while speaking
  • Getting lost in places that seemed to be familiar
  • Things getting lost
  • Allergic reaction
  • Loss of scalp hair
  • Extreme hair growth on the face, chest, abdomen, or legs

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Imvexxy Warnings

Imvexxy is not allowed for use in patients with the following health conditions. If you have any of these conditions, talk to a medical expert before starting your treatment with this medication.

• Abnormal Vaginal Bleeding: If you are experiencing recent unexplained vaginal spotting or bleeding, call your healthcare provider right away. This bleeding, especially after menopause, can be an early indication of endometrial cancer (uterine cancer).
• Breast Cancer: If you have breast cancer, avoid taking Imvexxy, as this estrogen therapy may make certain types of breast cancer grow and develop. Females with bone metastases are at high risk of hypercalcemia or high calcium levels in the blood with estrogen therapy.
• Hormone-Related Cancer: Patients with any cancer that is affected by hormone levels should not take this medication. Moreover, if you have had cancer and are not sure if it is related to hormones or not, talk to your healthcare provider and get it examined right away.
• Blood Clots: Estrogen therapy, including Imvexxy, can increase the chances of blood clots. Therefore, if you have had a blood clot or have had one in the past, avoid taking such therapies. 
• Heart Attack, Stroke, or Bleeding Disorder: Patients with a history of health problems like heart attack, stroke, or bleeding problems should not use Imvexxy as it is highly likely that this medication can increase the possibility of these conditions happening again.
• Liver Issues: If you have liver problems, your body may be unable to break down estrogens properly. This lack of metabolization can result in the accumulation of estrogens in the body and put you at higher risk of adverse effects from Imvexxy. 
• Allergies: If you have had a serious allergic reaction from Imvexxy or any of its components, including an anaphylactic reaction, do not take this medication. Talk to your medical provider, and they will suggest alternate options for you.

Imvexxy Boxed Warnings

This medication has boxed warnings about the high chances of endometrial cancer, heart and blood vessel issues, dementia, and breast cancer. A black box or boxed warning is the most critical warning issued by the FDA (Food and Drug Administration). 

• Endometrial Cancer: It has been observed that estrogen treatments, including those with Imvexxy, can increase the risk of endometrial cancer (cancer that occurs in the lining of the uterus) in patients. Due to this, medical practitioners advise against using this medication in patients with unusual genital bleeding without a known cause.
• Heart & Blood Vessel Problems: According to the WHI studies (Women’s Health Initiative), using estrogen-alone drugs like Imvexxy may increase the chances of heart and blood vessel problems. Its examples include stroke and deep vein thrombosis (DVT).
• Dementia: Using hormone therapies, be it estrogen-alone medications, like Imvexxy or estrogen-progesterone therapy, may develop the risk of dementia (memory problems). Women aged 65 years or above have a higher chance of developing this condition.
• Breast Cancer: Using hormone therapy, including estrogen and progesterone, increases the chances of breast cancer, and one of its examples is Imvexxy, as it contains estrogen. As a result, doctors do not recommend this medication to patients who have a history of active breast cancer.

Imvexxy Precautions

• Before starting your treatment with Imvexxy, tell your doctor about allergies you may have or if you are allergic to the medication’s ingredients. This product may contain certain inactive components, which can cause severe allergic reactions. 
• Before undergoing any medical surgery or procedure, inform your doctor about the products you use. This may include all prescription drugs, nonprescription drugs, and herbal products.
• Avoid smoking or consuming tobacco products as the combination of these substances with estrogens can further increase your chances of blood clots, stroke, high blood pressure, & heart attack, especially in women older than 35 years.
• Before starting your hormone replacement therapy, including Imvexxy, inform your medical professional if you had surgery or will have one in the future or if you will be restricted to a chair or bed for a prolonged period, like a long plane flight. It is important as these conditions may increase the chances of blood clots, especially if you are using an estrogen product. Your doctor may temporarily discontinue the medication or will suggest special precautions.
• Imvexxy may cause melasma (blotchy, dark areas on the skin), and exposure to sunlight can worsen it. Therefore, it is advised to avoid long exposure to the sun, tanning booths, and sunlamps. Take measures like wearing protective clothing and using sunscreen on the face when going outside during the daytime.
• If you wear contact lenses or are shortsighted, you can develop vision problems. So, talk to an eye specialist if you experience these problems.
• Avoid using Imvexxy during your pregnancy or even if you are planning to have a baby. Consult an expert before making any decision.
• If you are a breastfeeding woman, do not use this medication as the drug can enter into the breast milk & affect the infant. Talk to a medical practitioner and get their expert opinion if you have doubts about breastfeeding while using Imvexxy.
• Do not use estrogen-alone medications to treat conditions like heart attacks, strokes, or dementia.
• When using Imvexxy, you may experience headache, nausea, vomiting, and breast tenderness or pain. If these symptoms do not go away or worsen over time, talk to your healthcare professional immediately. 
• If you are 65 years or older taking Imvexxy, it is highly likely that you may experience stroke, breast cancer, and dementia. Consult with a medical provider, as they will closely monitor you for these conditions.
• Estrogen therapies may exacerbate your condition of high triglycerides, possibly leading to pancreatitis. If you have such a condition and take Imvexxy, visit your doctor. They will examine your health more closely.
• Estrogen therapy can affect thyroid hormone levels. If you are taking a thyroid replacement drug like levothyroxine with this medication, talk to your doctor first. They will schedule a blood test to check your thyroid levels and may adjust your dosage of Imvexxy accordingly.
• Make sure to tell your medical practitioner about your medical conditions before starting your treatment with Imvexxy. These conditions may include:
  • Migraine
  • Lupus
  • Asthma
  • Diabetes
  • Epilepsy 
  • Porphyria
  • Hepatic hemangiomas
  • Hereditary angioedema

Imvexxy Contraindications

This medication is contraindicated in women who have:

• Liver dysfunction or diseases and their liver functions have failed to return to normal levels
• Estrogen-dependent fatal neoplasms (endometrial cancer)
• Endometrial hyperplasia
• Known or history of breast cancer
• Undiagnosed abnormal genital bleeding
• Known or suspected pregnancy
• Known or history of arterial thromboembolic diseases, like myocardial infarction, stroke, or coronary heart disease
• Active or past history of venous thromboembolism, like DVT or pulmonary embolism

Imvexxy Missed Dose

Generally, patients are advised not to miss or skip any doses of Imvexxy, but if you have mistakenly missed a dose of your medication, take the following actions:

• If you miss a dose within the first 2 weeks, you can skip the missed dose. Do not take more than one dose of your medication in a day.
• If you miss a dose after 2 weeks of beginning the treatment, take it as soon as possible or whenever you remember. If it is almost time for your next dose, avoid taking the missed dose. 
• Do not take the capsules more than once every 3 to 4 days.
• If you are still not satisfied, you can talk to your healthcare practitioner and clear any doubts you have about the situation.
• Use medication apps or set reminders on your phone to avoid missing any doses.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Imvexxy Overdose

Overdosing any medication is not at all recommended by any medical professional. Exceeding the maximum daily dose of Imvexxy can lead to adverse reactions, which can be life-threatening. If you are experiencing any of the following symptoms of Imvexxy overdose, visit the nearest clinic or call 911 immediately without going into panic mode.

• Breast tenderness
• Nausea
• Vomiting
• Abdominal pain
• Withdrawal vaginal bleeding
• Fatigue

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Imvexxy Storage

• Keep the capsules in their original container and store them at a room temperature of 20°C to 25°C.
• Make sure to keep the medication away from light and moisture.
• Do not keep them in damp areas like the bathroom or near the sink.
• Store the medications somewhere safe, out of reach, and in sight of children.
• If you do not need any more capsules or have leftover medication, discard them safely.
• Throw the capsules when they reach their expiration date.
• Ask a medical professional or pharmacist how to dispose of the product properly when not in use without harming the environment.
• Avoid refrigerating the capsules.
• Do not flush the medications down the toilet.
• Read the product’s label beforehand for detailed storage information.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Imvexxy Interactions

Imvexxy may interact with different medications, including supplements and certain foods. These distinct interactions can cause different effects on the patient’s body. While some interactions can affect the drug’s ability to function effectively, others can increase its side effects. Following are some of the drugs that can interact with Imvexxy and cause life-threatening effects:

• Abrocitinib
• Anastrozole
• Baricitinib
• Clarithromycin
• Carfilzomib
• Dantrolene
• Exemestane
• Fedratinib
• Fezolinetant
• Hemin
• Lenalidomide
• Letrozole
• Momelotinib
• Alogliptin
• Aminoglutethimide
• Budesonide
• Bexarotene
• Calcitriol topical
• Cortisone
• Dapagliflozin
• Darunavir
• Empagliflozin
• Encorafenib
• Fludrocortisone
• Fluvoxamine
• Glipizide
• Glyburide
• Hydrocortisone
• Itraconazole
• Ivacaftor
• Ketoconazole
• Liraglutide
• Lixisenatide
• Mephobarbital
• Metformin
• Nateglinide
• Nefazodone
• Pacritinib
• Pomalidomide
• Rifabutin
• Rifampin
• Rifapentine
• Tirzepatide
• Tofacitinib
• Upadacitinib

[Note: This isn’t a complete list, and there could be other drugs that interact with Imvexxy. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Imvexxy Alternatives

• Conjugated estrogens vaginal cream (Premarin Vaginal)
• Estradiol vaginal cream (Estrace Vaginal)
• Estradiol vaginal ring (Estring, Femring)
• Estradiol vaginal tablet (Vagifem, Yuvafem)
• Ospemifene oral tablet (Osphena)
• Prasterone vaginal insert (Intrarosa)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

What happens to the Imvexxy capsules after I insert them into my vagina?

After inserting Imvexxy capsules into the vagina, they dissolve and release estradiol, the active ingredient. This hormone is absorbed directly into the vaginal tissues, where it helps to ease symptoms of vulvar and vaginal atrophy (VVA) by increasing moisture, elasticity, and thickness of the vaginal walls. 

Can I experience vaginal discharge while using Imvexxy capsules?

Yes, it is possible to experience vaginal discharge while using Imvexxy capsules. This discharge is typically a result of the capsules dissolving and releasing their contents into the vaginal area. It is generally common and should not be cause for concern. However, if you notice any unusual symptoms with discharge, such as a strong odor, itching, or irritation, it is important to consult a medical professional to rule out any potential infections or adverse reactions.

Can I use Imvexxy capsules if I am not menopausal?

Imvexxy capsules are prescribed to postmenopausal women who are experiencing symptoms of VVA. They are not recommended for use by women who have not yet reached menopause, as the hormonal needs and conditions treated by Imvexxy are specific to postmenopausal hormonal changes. Using this medication without being menopausal may not provide the mentioned benefits and could lead to unnecessary side effects.

What is the best time to use Imvexxy capsules?

The best time to use Imvexxy capsules is at bedtime. Inserting the medication before lying down allows the capsules to remain in place and dissolve properly, ensuring maximum absorption of estradiol into the vaginal tissues. This nighttime routine can also help minimize any potential leakage or discomfort that might occur during daytime activities, allowing for more effective relief from symptoms of vulvar and vaginal atrophy.

Are there any dietary restrictions while using Imvexxy?

There are no specific dietary restrictions associated with using Imvexxy. Patients can continue their usual diet while on this medication. However, maintaining a balanced diet and staying hydrated can support overall health and well-being. It is always a good idea to consult with a healthcare provider about any potential interactions with other medications or supplements being taken, but generally, no special dietary changes are required while using Imvexxy.

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