Imvexxy

The active ingredient in Imvexxy is estradiol. It is a type of estrogen therapy that delivers the hormone directly to the vagina. By increasing estrogen levels, Imvexxy helps to reduce vaginal dryness, itching, burning, and irritation.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Imvexxy. However, the following is a synopsis of the general guidelines for the use of Imvexxy:

• Imvexxy is typically given as 1 vaginal insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Monday and Thursday)
• When you want to insert Imvexxy, wash your hands with soap and warm water. Do not remove the medication from the packaging it comes in until you know that you are ready to use it. All packaging can be thrown away after each daily use
• Never take Imvexxy by mouth. In order to insert it, hold the large end of the capsule between your fingers with the smaller end facing up. Now, with your finger, insert the capsule approximately two inches into your vagina. You can choose whether you take Imvexxy standing up or sitting down
• Especially after your first dose, watch for side effects such as irritation. Make sure you wash your hands after you have applied Imvexxy
• If you miss a dose, do not take two doses at once. Instead, take the missed dose as soon as you can on the same day. The next day, return to your normal schedule
• You should ensure that you get complete physical exams, such as breast exam (mammogram), blood pressure, pelvic exam, and pap smear throughout your treatment course with Imvexxy
• Continue to take all prescribed medications as your doctor instructs. Your healthcare professional may recommend that you take a progestin as well to decrease your chances of developing endometrial hyperplasia

The most common side effects of Imvexxy seen in clinical trials as compared to placebo include:

• Headache
• Vaginal yeast infections
• Itching of the vagina or vulva area
• Back pain
• Breast tenderness
• Diarrhea
• Depression
• Trouble sleeping
• Irritation after application

Some individuals may experience serious side effects while using Imvexxy. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction. Symptoms could include:
• Swelling of your lips, face, throat, or tongue
• Trouble breathing
• Breast cancer
• Uterine (endometrial) cancer
• Dementia
• Blood clots, stroke, heart attack
• Inflammation of the pancreas
• Gallbladder problems or gallbladder disease
• Eye problems
• Cholestatic jaundice
• Hypertriglyceridemia (high triglycerides or fats in the blood)

These are not all of the possible side effects of Imvexxy. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Imvexxy, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Breast cancer or a history of breast cancer
• Any estrogen-dependent cancers
• Active arterial thromboembolic disease, or a history of conditions such as these, including:
• A history of heart attack
• Stroke
• Active blood clots (in your lungs or legs), or a history of conditions such as these
• Abnormal vaginal bleeding that has not been diagnosed
• Abnormal genital bleeding could be an indication of uterine (womb) cancer.
• Endometriosis
• Liver disease or damage
• Blood-clotting problems
• Porphyria
• Thyroid issues, and are on thyroid replacement therapy
• Women on thyroid replacement hormone therapy should be monitored while taking Imvexxy.
• A known anaphylactic reaction or angioedema to any ingredient in Imvexxy
• Epilepsy (seizures)
• Asthma
• Diabetes
• High blood pressure

Boxed Warning

As of right now, there is a boxed warning for Imvexxy. The warning consists of cardiovascular disorders, endometrial cancer, and breast cancer. The warning is broken down as follows:

Estrogen-alone therapy:

If you are a woman with a uterus & use unopposed estrogens, there is an increased risk of endometrial cancer.

The Women’s Health Initiative (WHI) estrogen-alone substudy has reported that there is an increased risk of deep vein thrombosis (DVT) and stroke.

WHI conducted a Memory Study known as an estrogen-alone ancillary study that reported that there is an increased risk of dementia if you are a postmenopausal woman 65 years of age or older.

Estrogen-alone therapy should not be used in the prevention of dementia or cardiovascular disease.

Estrogen with progestin therapy:

The WHI conducted an estrogen plus progestin substudy that has reported an increased risk of pulmonary embolism (PE), stroke, DVT, and myocardial infarction (MI).

The WHI also found that estrogen plus progestin has an increased risk of invasive breast cancer.

The WHIMS estrogen plus progestin ancillary study of WHI has reported that there is an increased risk of probable dementia in postmenopausal women who are 65 years of age or older.

Estrogen plus progestin should not be used in the prevention of cardiovascular disease or dementia.

Imvexxy (estradiol vaginal inserts) is contraindicated in the following situations:

• Undiagnosed abnormal genital bleeding; any unexplained vaginal bleeding should be evaluated before using Imvexxy.
• Known or suspected estrogen-dependent cancers, such as breast or uterine cancer.
• Active or history of venous thromboembolism (VTE), including deep vein thrombosis (DVT) or pulmonary embolism (PE).
• Active or history of arterial thromboembolic disease, such as stroke or myocardial infarction.
• Known liver dysfunction or disease, as estrogen metabolism may be impaired.
• Known or suspected pregnancy; Imvexxy is not for use during pregnancy.
• Hypersensitivity to estradiol or any components of the insert.

Imvexxy (estradiol vaginal inserts) may begin to relieve symptoms of vaginal dryness, discomfort, or pain during intercourse within 2 to 4 weeks of starting treatment. Full benefits are often achieved after 12 weeks of consistent use. If symptoms persist or worsen, consult your healthcare provider.

When Imvexxy is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Inducers and inhibitors of CYP3A4.
• These medications may affect the estrogen drug’s ability to metabolize and increase or decrease the estrogen plasma concentration in your body.

Imvexxy comes as an estradiol vaginal insert in the following dosage forms:

• 4 mcg
• 10 mcg

Imvexxy should be stored at room temperature, with excursions accepted 15ºC to 30ºC (59ºF to 86ºF). In general, medication should be kept away from children, excessive heat, and moisture.

Imvexxy is manufactured by TherapeuticsMD.

Currently, there are no lower-cost generics available for Imvexxy.

To stop taking Imvexxy, consult your healthcare provider first. They can guide you on safely discontinuing the treatment and managing any symptoms that might return. Abruptly stopping may lead to the recurrence of symptoms, so always follow your doctor's recommendations.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Imvexxy is not recommended to be used with pregnant women.

Estrogen therapy may decrease breast milk production in breastfeeding females. However, Imvexxy is not approved for use in females who can breastfeed. It is only used in females who have gone through menopause.