Vagifem

Vagifem is a prescription medication used to treat menopausal changes in and around the vagina.

Vagifem contains estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as a tablet that is inserted into the vagina. It is usually inserted once a day for 2 weeks then twice a week, for as long as you use Vagifem.

Common side effects of Vagifem include upper respiratory tract infection, headache, and stomach pain.

Vagifem is a prescription medication used to treat menopausal changes in and around the vagina.

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

• Novo Nordisk, Inc.

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

Common side effects of Vagifem include the following:

• Upper respiratory tract infection
• Stomach pain
• Back pain
• Itching of the vagina
• Diarrhea
• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection

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

Tell your doctor if you have any side effect that bothers you or that does 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:

• Amiodarone (Cordarone, Pacerone)
• 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), delaviridine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

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

Serious side effects have been reported with Vagifem including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not take Vagifem if you:

• are allergic to Vagifem or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently have or have a history of blood clots
• have had a heart attack or stroke
• have been diagnosed with a bleeding disorder
• have liver disease
• are pregnant or possibly pregnant

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

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

• are allergic to Vagifem or to any of its ingredients
• currently have or have had certain cancers 
• currently have or have a history of blood clots
• have had a heart attack or stroke
• 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.
• have been diagnosed with a bleeding disorder
• are pregnant or breastfeeding

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.

Vagifem should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Vagifem. 

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

Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Vagifem should not be used during lactation. Caution should be taken when Vagifem is given to a nursing woman.

Use Vagifem exactly as prescribed.

Vagifem is available as a tablet that is inserted into the vagina. It is usually inserted once a day for 2 weeks then twice a week, for as long as you use Vagifem.

Step 1: Tear off a single applicator.

Step 2: Separate the plastic wrap and remove the applicator from the plastic wrap as shown in Figure A. 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 (see Figures C and D above). 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). 

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:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose for Vagifem (estradiol) tablets for menopause symptoms is 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.

If you insert too many Vagifem tablets, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Vagifem at 25ºC (77ºF).
• Keep this and all medicines out of the reach of children.

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

Estrogen-Alone Therapy

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens 

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)

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen Plus Progestin Therapy

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 stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) 

The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older