Vagifem is used after menopause to treat menopausal changes in and around the vagina. Symptoms treated are:
- vaginal dryness, itching, and burning
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Vagifem (estradiol vaginal tablets) are small, white, film-coated tablets containing estradiol. Each tablet also contains hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol.
Each Vagifem tablet is contained in a disposable applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.
Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not refrigerate.
Vagifem therapy consists of the following dosing regimen:
One (1) Vagifem tablet inserted vaginally once daily for the first two (2) weeks, then one (1) tablet inserted twice weekly (for example Tuesday and Friday) for as long as you use Vagifem.
Vagifem is only used in the vagina; however, the risks associated with oral estrogens should be taken into account.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious but less common side effects include:
- Heart attack
- Stroke
- Blood clots
- Dementia
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
- 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
Less serious, but common, side effects include:
- Headache
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all the possible side effects of Vagifem. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
To lower your chances of a serious side effect with Vagifem:
- Talk with your healthcare provider regularly about whether you should continue using Vagifem
- If you have a uterus, 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 a woman 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 Vagifem.
- 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 ever 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 higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.
Vagifem is a tablet that you place in your vagina with an applicator.
- Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you.
- Estrogens should be used at the lowest dose possible for your treatment only as long as needed.
- 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 Vagifem.
Step 1: Tear off a single applicator.
Step 2: Separate the plastic wrap and remove the applicator from the plastic wrap. If after opening the package you see that the tablet has come out of the applicator but has not fallen out of the package, carefully put it back into the applicator for insertion. Please keep your hands clean and dry while handling the tablet.
Step 3: Hold the applicator so that the finger of one hand can press the applicator plunger.
Step 4: Next select the best position for vaginal insertion of Vagifem (estradiol vaginal tablets) that is most comfortable for you.
Step 5: Using the other hand, guide the applicator gently and comfortably through the vaginal opening. If prior to insertion the tablet falls out of the applicator, throw the tablet and applicator away and use a new tablet-filled applicator.
Step 6: The applicator should be inserted (without forcing) as far as comfortably possible, or until half of the applicator is inside your vagina, whichever is less.
Step 7: Once the tablet-filled applicator has been inserted, gently press the plunger until the plunger is fully depressed. This will eject the tablet inside your vagina where it will dissolve slowly over several hours.
Step 8: After depressing the plunger, gently remove the applicator and dispose of it the same way you would a plastic tampon applicator. The applicator is of no further use and should be discarded properly. Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of Vagifem (estradiol vaginal tablets). If you have any questions, please consult your healthcare provider or pharmacist.
Vagifem should not be used during pregnancy. Although Vagifem is not recommended for use in pregnancy, there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as oral contraceptive (birth control pills) inadvertently during early pregnancy.
If you are using Vagifem and become pregnant, contact your healthcare provider.
Important information about Vagifem (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 Vagifem. 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 attack, strokes or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years of age or older
Do not start using Vagifem if you:
- Have unusual vaginal bleeding
- 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. If you have or have had cancer, talk with your healthcare provider about whether you should use Vagifem.
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to Vagifem or any of its ingredients
- Think you may be pregnant
Keep Vagifem and all medications out of the reach of children.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- amiodarone (Cordarone, Pacerone);
- certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral);
- aprepitant (Emend);
- carbamazepine (Carbatrol, Epitol, Tegretol);
- cimetidine (Tagamet);
- clarithromycin (Biaxin);
- cyclosporine (Neoral, Sandimmune);
- dexamethasone (Decadron, Dexpak);
- diltiazem (Cardizem, Dilacor, Tiazac, others);
- erythromycin (E.E.S, Erythrocin);
- fluoxetine (Prozac, Sarafem);
- fluvoxamine (Luvox);
- griseofulvin (Fulvicin, Grifulvin, Gris-PEG);
- lovastatin (Altocor, Mevacor);
- medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase);
- medications for thyroid disease; other medications that are used vaginally;
- nefazodone;
- phenobarbital;
- phenytoin (Dilantin, Phenytek);
- rifabutin (Mycobutin);
- rifampin (Rifadin, Rimactane, in Rifamate);
- sertraline (Zoloft);
- troleandomycin (TAO);
- verapamil (Calan, Covera, Isoptin, Verelan);
- and zafirlukast (Accolate)
This is not a complete list of Vagifem drug interactions. Ask your healthcare provider or pharmacist for more information.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Vagifem is excreted in human breast milk and should not be used while breastfeeding. When estrogen is given to nursing women, it has been shown to decrease the quantity and quality of the breast milk.
If you take too much Vagifem, call your local Poison Control Center or seek emergency medical attention right away.
Tell your healthcare provider:
- If you have any unusual vaginal bleeding. 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.
- About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vagifem works. Vagifem may also affect how your other medicines work.
- If you are going to have surgery or will be on bed rest. You may need to stop using Vagifem.
- If you are breastfeeding. The hormone in Vagifem can pass into your breast milk.
Vagifem (generic: estradiol) is a prescription medication used to treat vaginal dryness, itching and burning caused low estrogen levels after menopause. Vagifem belongs to a group of drugs called estrogen hormones, which works to relieve the vaginal symptoms by replacing estrogen the body no longer produces.
This medication come in the form of a tablet to be inserted into the vagina using an applicator. Vagifem is used every day for two weeks, then just twice a week for the duration of treatment.
Common side effects of Vagifem include headache, breast pain, and vaginal bleeding.
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 or 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.