estradiol 4 mcg vaginal insert

Generic name:
Estradiol insert - vaginal

Pronunciation
(ES-tra-DYE-ol)

Brand name(s)
Imvexxy

Estrogens, either used alone or with another hormone (progestin), have rarely caused very serious side effects. Discuss the risks and benefits of hormone treatment with your doctor. Estrogens should not be used to prevent heart disease or dementia.

Estrogens can increase the risk of cancer of the uterus (endometrial cancer). Taking a progestin as directed by your doctor can help decrease this risk. Tell your doctor right away if you have any unusual vaginal bleeding.

In postmenopausal women, estrogens, taken with or without a progestin, increase the risk of cancer of the breast/ovaries, stroke, dementia, and serious blood clots. When used along with a progestin, estrogens also increase the risk of heart disease (such as heart attacks).

The risk for serious side effects may depend on the dose of estrogen and the length of time it is used. This medication should be used at the lowest effective dose and for the shortest amount of time. Discuss the use of this medication with your doctor and check with him/her regularly (for example, every 3 to 6 months) to see if you still need to use this medication. If you will be using this medication long-term, you should have regular complete physical exams (for example, once a year) as directed by your doctor. See also Notes section.

This medication is a hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Wash and dry your hands before handling the insert. Select the best position for vaginal insertion that is most comfortable for you. Hold the insert with the larger end between your fingers and place it about 2 inches into your vagina as directed. Use this medication vaginally as directed by your doctor, usually once daily for the first 2 weeks, then 2 times a week, every 3 to 4 days (for example, every Monday and Thursday).

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder. Do not increase your dose or use this medication more often or for longer than prescribed.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Nausea/vomiting, bloating, diarrhea, breast tenderness, headache, or weight changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as new/worsening depression)
• lumps in the breast
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding)
• increased or new vaginal irritation/itching/odor/discharge
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• swelling hands/ankles/feet
• symptoms of high blood sugar (such as increased thirst/urination)

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using estradiol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots (for example, in the legs, eyes, lungs)
• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• high cholesterol or triglyceride (blood fat) levels
• mental/mood disorders (such as dementia, depression)
• diabetes
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder problems
• severe headaches/migraines
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• kidney disease
• liver disease (including tumors)
• stroke
• swelling (edema)
• thyroid problems
• unexplained vaginal bleeding
• a certain hormone problem (hypoparathyroidism)

Do not smoke or use tobacco. Estrogens combined with smoking further increase your risk of stroke, blood clots, high blood pressure, and heart attack, especially in women older than 35.

Tell your doctor if you just had or will be having surgery, or if you will be confined to a chair or bed for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using an estrogen product. You may need to stop this medication for a time or take special precautions.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

This medication passes into breast milk. However, it is unlikely to be used by a breastfeeding woman. Consult your doctor if you have questions about breastfeeding while using this medication.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• fulvestrant
• ospemifene
• raloxifene
• tamoxifen
• toremifene
• tranexamic acid

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting, unusual vaginal bleeding.

Do not share this medication with others.

Keep all regular medical and lab appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your breasts, and report any lumps right away. Consult your doctor for more details.

Preventing or controlling high blood pressure, high cholesterol, and diabetes can help to reduce your chances of heart disease and stroke. Lifestyle changes that can help to control or prevent these diseases include reducing stress, eating a low fat/salt diet, losing weight if overweight, exercising regularly, and stopping smoking. Keep your mind active with mental exercises (such as reading, solving crossword puzzles) to help prevent dementia. Talk to your doctor about lifestyle changes that might benefit you.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not refrigerate. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.