Imvexxy contains estradiol as the active ingredient in the form of vaginal inserts. It is an estrogen medication available in 4 mcg or 10 mcg strengths, designed for intravaginal use. Inactive ingredients include ammonium hydroxide, ethanol, and gelatin. The inserts are intended to release estradiol when placed in the vagina.

How should I use this medication?

This medication is for vaginal use only. Do not take by mouth. Follow the directions that are included with your prescription. Wash hands before and after use. Keep using this medication unless your care team tells you to stop. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently. Contact your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Breast tissue changes, new lumps, redness, pain, or discharge from the nipple -Change in vision -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Increase in blood pressure -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Unusual vaginal discharge, itching, or odor -Vaginal bleeding after menopause, pelvic pain Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Bloating -Breast pain or tenderness -Hair loss -Nausea -Stomach pain -Swelling of the ankles, hands, or feet -Vaginal irritation at application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Asthma -Blood clotting disorder or history of blood clots -Cancer, such as breast, cervical, or liver cancer -Diabetes -Gallbladder disease -Having surgery -Heart or blood vessel conditions -Hereditary angioedema, a genetic condition that causes episodes of severe swelling -High blood pressure -High cholesterol -High levels of calcium in your blood -History of heart attack -History of stroke -Hysterectomy -Kidney disease -Liver disease -Lupus -Migraine or other severe headaches -Porphyria -Seizures -Thyroid disease -Tobacco use -Unusual vaginal bleeding -An unusual or allergic reaction to estrogens, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Talk to your care team about how often you should have a pelvic exam, breast exam, and a mammogram. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team right away if you have vaginal bleeding while on this medication. If you have a uterus, talk to your care team about whether adding a progestin to your hormone therapy is right for you. Taking progestins with estrogen therapy may lower the risk of uterine cancer, but can have other health risks. This medication can increase the risk of serious blood clots, which can cause a heart attack or stroke. The risk increases if you are older than 35 years of age or use tobacco. Talk to your care team if you use tobacco products. This medication can cause dry eyes or a slight change in the shape of the eye. This can affect how contact lenses fit and feel. If you wear contact lenses, talk to your care team if you have eye discomfort or vision changes. They can help you find a solution, such as a change in contact lens or eye drops for dryness. If you are going to need surgery or other procedure, tell your care team that you are using this medication. If you may be pregnant, stop taking this medication right away and contact your care team.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots. Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps. Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older. If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).