Imvexxy

Imvexxy is a prescription medication used to treat painful intercourse due to drying and thinning of the vaginal lining after menopause (the point in life at which a woman’s period stops).

Imvexxy belongs to a group of drugs called hormones and works by replacing the female hormone estrogen in the body.

This medication comes in a vaginal insert and is usually used once a day for 2 weeks followed by once every 3 to 4 days.

Common side effects include headache, breast tenderness, and nausea.

Imvexxy is a prescription medication used to treat painful intercourse due to drying and thinning of the vaginal lining after menopause (the point in life at which a woman’s period stops).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Imvexxy. See the “Imvexxy Precautions” section.

Common side effects of Imvexxy include:

• Headache
• Breast tenderness
• Nausea
• Vomiting

This is not a complete list of Imvexxy side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone

This is not a complete list of Imvexxy drug interactions. Ask your doctor or pharmacist for more information.

Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects could include:

• heart attack 
• cancer of the ovary 
• dementia 
• changes in vision 
• liver problems 
• low blood calcium (hypocalcemia) 
• worsening of angioedema (swelling of face and tongue)
• stroke 
• breast cancer 
• gallbladder disease 
• high blood pressure 
• low thyroid levels in your blood 
• changes in certain laboratory test results
• blood clots 
• cancer of the lining of the uterus (womb) 
• high blood calcium (hypercalcemia) 
• high triglyceride (fat) levels in your blood 
• fluid retention 
• enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• new breast lumps 
• unusual vaginal bleeding 
• changes in vision or speech 
• sudden, new, severe headaches 
• severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

Important information you should know about Imvexxy (an estrogen hormone):

• Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
• Report any unusual vaginal bleeding right away while you are using Imvexxy. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
• Using estrogen-alone may increase your chances of getting strokes or blood clots.
• Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia.
• Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood
• clots.
• Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• You and your healthcare provider should talk regularly about whether you still need treatment with Imvexxy.

You may lower your chances of a serious side effect with Imvexxy by taking the following steps:

• Talk with your healthcare provider regularly about whether you should continue using Imvexxy. 
• If you have a uterus (womb), talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus. 
• See your healthcare provider right away if you get vaginal bleeding while using Imvexxy. 
• Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have had breast lumps or an abnormal mammogram, you may need to have breast exams more often. 
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.

Do not take Imvexxy if you:

• have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
• currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Imvexxy.
• currently have or have had blood clots.
• had a stroke or heart attack.
• currently have or have had liver problems.
• have been diagnosed with a bleeding disorder.
• are allergic to Imvexxy or any of its ingredients. See the list of ingredients in Imvexxy at the end of this leaflet.
• think you may be pregnant. Imvexxy is not for pregnant women.

Grapefruit and grapefruit juice may interact with Imvexxy and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Imvexxy, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Imvexxy or to any of its ingredients
• have any unusual vaginal bleeding
• have  asthma
• have a seizure disorder
• have or have had diabetes
• have or have had migraines
• have lupus
• have or have had angioedema (swelling of the face and tongue)
• have endometriosis
• have or have had heart problems
• have or have had kidney problems
• have or have had liver problems
• have or have had thyroid problems
• have or have had high calcium levels in your blood
• are going to have surgery or will be on bed rest
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies of Imvexxy in pregnant women. However, studies of estrogens taken by women during early pregnancy have shown an increased risk of babies born with problems. Imvexxy is not recommended for pregnant women. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Imvexxy has been detected in human breast milk. Estrogens are present in human milk and can reduce milk production in breast-feeding females. Because of the possibility for adverse reactions in nursing infants from Imvexxy, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Use Imvexxy exactly as your healthcare provider tells you to use it. 

• Imvexxy is a vaginal insert that you place in your vagina. 
• Imvexxy is only for use in the vagina. Do not take Imvexxy by mouth (orally). 
• Estrogens should be used at the lowest dose possible for your treatment and for only as long as needed. 
• Put 1 Imvexxy insert inside your vagina, 1 time a day at about the same time for the first two weeks. 
• Then put 1 Imvexxy insert into your vagina two times a week, every three to four days (for example, Monday and Thursday), for as long as you use Imvexxy. 
• You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with Imvexxy.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Generally, women should be started at the 4 mcg dosage strength. Insert 1 daily at approximately the same time for 2 weeks, followed by 1 insert twice weekly, every three to four days (for example, Monday and Thursday). Your doctor may decide to change your dosage based on your body's response to this medication.

If you take too much Imvexxy, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Imvexxy at room temperature between 68°F to 77oF (20°C to 25oC).

• Imvexxy packaging is not child-resistant.

• Keep Imvexxy and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia

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

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

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

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg] relative to placebo.

The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age of older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.