Brand Name

Vagifem {Novo-Nordisk}

Generic Name

estradiol, pronounced es tra DYE ole

---

Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Vagifem?

Vagifem is used to treat vaginal atrophy, which is a chronic condition that affects the vagina and the surrounding tissues both during and after menopause.

Vagifem may be used for purposes not described in this medication guide.

Key Facts About Vagifem

Vaginal atrophy may cause you to have symptoms such as vaginal dryness and irritation, vaginal soreness, pain and bleeding during intercourse and painful urination. Your doctor will confirm your diagnosis of vaginal atrophy and determine if Vagifem is right for you.

Vagifem is for vaginal administration only.

Vagifem is estradiol and is a form of estrogen. Estrogen is a female sex hormone produced by the ovaries, and is necessary for many processes in your body.

Vagifem is in FDA pregnancy category X. Vagifem can harm your unborn baby and cause birth defects. You should not use Vagifem if you are pregnant, and you must tell your doctor immediately if you become pregnant during treatment with this medication. We know that Vagifem can pass into breast milk and may harm a nursing baby, and it may also slow your breast milk production. You should not breastfeed while you are taking Vagifem.

Vagifem should not be used to prevent heart disease, stroke, or dementia, because it may actually increase your risk of developing these conditions. Talk to your doctor if you are concerned about your risk for developing any of these conditions.

Taking Vagifem or any hormones may increase your risk of blood clots, stroke, or a heart attack, particularly if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you are overweight or if you smoke.

Vagifem treatment, if used long-term can increase your risk of breast cancer, ovarian cancer, or uterine cancer. You should talk with your doctor about your individual risks before using Vagifem for a prolonged period of time. Your doctor may wish to evaluate your treatment every 3 to 6 months to determine if you should continue taking Vagifem.

It is possible that taking progestin while also taking Vagifem may lower your risk of uterine cancer. If you have not had your uterus removed your doctor may prescribe progestin for you to take while you are being treated with Vagifem. Talk to your doctor if you are concerned about your risk for uterine cancer.

Before You Take Vagifem

If you are allergic to estradiol you should not use Vagifem.

If you have a historyuncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems or a previous heart attack, stroke or blood clot caused by a birth control pill you should not use Vagifem.

Do not use Vagifem if you have endometriosis, lupus or porphyria without talking to your doctor first.

If you have high levels of calcium in your blood, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer you may not be a candidate for a Vagifem.

Tell your doctor if you have severe migraine headaches (with aura, numbness, weakness, or vision changes), jaundice caused by pregnancy or birth control pills, diabetes, a hysterectomy, a blood clot (especially in your lungs or lower body), an underactive thyroid or gallbladder disease before using Vagifem.

Tell your doctor before starting treatment with Vagifem if you have depression, seizures or epilepsy, a history of irregular menstrual cycles, toxic shock syndrome, or easy vaginal irritation.

Let your doctor know if you have a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram before using Vagifem.

Vagifem Drug Interactions

You should inform your doctor if you are taking any of the following:

• dantrolene (Dantrium)
• hemin
  (Panhematin)
• lenalidomide
  (Revlomid)
• pomalidomide (Pomalyst)

Other drugs you take that are not listed may interact with Vagifem. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Using Vagifem

Use Vagifem exactly as your doctor has prescribed you to. Do not use it in larger or smaller amounts or for shorter or longer than recommended. Vagifem comes with patient instructions for so you can use this medication safely and effectively. Be sure to follow these instructions carefully.

Vagifem tablets are placed vaginally with an applicator, which is contained with your medication.

Typical dosing of Vagifem is one (1) Vagifem tablet inserted vaginally once a day for the first two (2) weeks, followed by one (1) tablet inserted twice a week for as long as your doctor has prescribed this medication.

You should have regular physical exams and mammograms, and self-examine your breasts for lumps each month while using Vagifem. Your doctor should check your progress every 3 to 6 months to evaluate whether you should continue taking Vagifem.

If you need medical tests or surgery, or if you will need to be on bed rest, you may need to stop using Vagifem for a short period of time. Be sure to tell any doctor or surgeon who treats you should know that you are being treated with Vagifem.

You should not smoke while you take Vagifem, as it will increase your risk of developing blood clots, a stroke, or a heart attack.

If you miss a dose of Vagifem you should take it as soon as you remember. If it is almost time for your next dose you should skip the dose you missed.

Vagifem needs to be stored in a cool, dry place, away from heat and moisture.

Vagifem Side Effects

Contact your doctor at once if you have a serious side effect such as:

• allergic reaction including breathing difficulties, hives and swelling of your face, lips, throat or tongue
• breast lump
• chest pain or a heavy feeling with pain spreading to your arm or shoulder, nausea, sweating and a general ill feeling
• dementia or unusual memory problems
• feeling faint, like you might pass out, fatigue and weakness
• headache that is severe or sudden with confusion, problems with vision, speech or balance
• jaundice or a yellowing of your skin or eyes
• nausea and upper stomach pain, with vomiting and increased thirst
• numbness and weakness that is sudden, or on one side of your body
• pain and swelling and tenderness in your stomach
• swelling in your hands, ankles, feet or legs, along with warmth and redness
• vaginal bleeding that is unusual, especially if you are past menopause
• wheezing and cough along with rapid breathing and a fast heart rate

Less serious side Vagifem effects may include:

• bloating
• breast pain, tenderness and swelling
• fluid retention
• headache
• loss of scalp hair
• menstrual cycle changes, break-through bleeding
• nausea
• stomach cramps
• vaginal discharge or itching
• vomiting

It should be noted that this is not a complete list of possible side effects of Vagifem. You should contact your physician for a complete list and medical advice regarding these effects.

Vagifem Description and Dosing

Vagifem is available in tablet form in 10 mcg and 25 mcg dosages. Your prescription of Vagifem will also contain disposable, single-use applicators packaged with your tablets in a blister pack.

Vagifem tablets are all small, white and film coated.

You should take Vagifem exactly as your doctor has directed you to. Do not change your dose of Vagifem or stop taking this medication without talking to your doctor first.

If you believe that you have overdosed with Vagifem you should seek medical help immediately.

Ingredients in Vagifem

Vagifem contains estradiol as the main and active ingredient. Other inactive ingredients include hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol.

Back to Top

The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.