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Vivelle-Dot®
(estradiol transdermal system)

Read this PATIENT INFORMATION before you start using Vivelle-Dot® (estradiol transdermal system) (estradiol transdermal system) and read all the information that you get each time you refill Vivelle-Dot (estradiol transdermal system) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

The Vivelle-Dot® (estradiol transdermal system) patch that your healthcare provider has prescribed for you releases small amounts of an estrogen hormone through the skin.

This leaflet describes the risks and benefits of treatment with Vivelle-Dot (estradiol transdermal system) . Vivelle-Dot (estradiol transdermal system) is not for everyone. Talk to your healthcare provider if you have any questions or concerns about this medication.

What is Vivelle-Dot® (estradiol transdermal system) ?

Vivelle-Dot (estradiol transdermal system) is a patch that contains the estrogen hormone, estradiol. When applied to the skin as directed below, Vivelle-Dot (estradiol transdermal system) releases estrogen through the skin into the bloodstream.

What is Vivelle-Dot (estradiol transdermal system) used for?

Vivelle-Dot (estradiol transdermal system) is used after menopause to:

• reduce moderate to severe hot flashes.

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.”

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden strong feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women, the symptoms are mild and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Vivelle-Dot (estradiol transdermal system) .

• treat moderate to severe dryness, itching and burning in or around the vagina.
  You and your healthcare provider should talk regularly about whether you still need treatment with Vivelle-Dot (estradiol transdermal system) to control these problems. If you use Vivelle-Dot (estradiol transdermal system) only to treat your dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.
• treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally.
• help reduce your chances of getting osteoporosis (thin weak bones).

Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use Vivelle-Dot (estradiol transdermal system) only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue with Vivelle-Dot (estradiol transdermal system) .

Weight-bearing exercise, like walking or running, and taking calcium and vitamin D supplements may also lower your chances of getting postmenopausal osteoporosis. It is important to talk about exercise and supplements with your healthcare provider before starting them.

Who should not take Vivelle-Dot (estradiol transdermal system) ?

Do not start taking Vivelle-Dot (estradiol transdermal system) 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 take Vivelle-Dot (estradiol transdermal system) .
• had a stroke or heart attack in the recent past (for example in the past year).
• currently have or have had blood clots.
• currently have or have had liver problems.
• are allergic to Vivelle-Dot (estradiol transdermal system) or any of its ingredients.
  See the end of this leaflet for a list of ingredients in Vivelle-Dot (estradiol transdermal system) .
• think you may be, or know that you are, pregnant.

Tell your healthcare provider:

if you are breast-feeding.The hormone in Vivelle-Dot (estradiol transdermal system) can pass into your milk.

• 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), migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vivelle-Dot (estradiol transdermal system) works. Vivelle-Dot (estradiol transdermal system) may also affect how other medicines work.
• if you are going to have surgery or will be on bed rest.You may need to stop taking estrogens.

How should I take Vivelle-Dot (estradiol transdermal system) ?

1. Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
2. Estrogens should be used at the lowest dose possible for your treatment, only as long as needed. The lowest effective dose of Vivelle-Dot (estradiol transdermal system) has not been determined for any indication. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Vivelle-Dot (estradiol transdermal system) .

Application Instructions for Vivelle-Dot (estradiol transdermal system)

1. Determine Your Schedule for Your Twice-a-Week Application

• Decide upon which two days you will change your patch.
• Your Vivelle-Dot® (estradiol transdermal system) individual carton contains a calendar card printed on its inner flap. Mark the two-day schedule you plan to follow on your carton's inner flap.
• BE CONSISTENT.
• If you forget to change your patch on the correct date, apply a new one as soon as you remember.
• No matter what day this happens, stick to the schedule you have marked on the inner flap of your carton (your calendar card).

2. Where to Apply Vivelle-Dot® (estradiol transdermal system)

• Apply patch to lower abdomen, below the waistline. Avoid the waistline, since clothing may cause the patch to rub off.
• DO NOT APPLY PATCH TO BREASTS.
• When changing your patch, based on your twice-a-week schedule, apply your new patch to a different site. Do not apply a new patch to that same area for at least one week.

3. Before You Apply Vivelle-Dot® (estradiol transdermal system)

• Make sure your skin is:
• Clean (freshly washed), dry and cool.
• Free of any powder, oil, moisturizer or lotion.
• Free of cuts and/or irritations (rashes or other skin problems).

4. How to Apply Vivelle-Dot® (estradiol transdermal system)

• Each patch is individually sealed in a protective pouch.
• Tear open the pouch at the tear notch (do not use scissors).
• Remove the patch.

• Apply the patch immediately after removing from pouch.
• Holding the patch with the rigid protective liner facing you, remove half of the liner, which covers the sticky surface of the patch.

• AVOID TOUCHING THE STICKY SIDE OF THE PATCH WITH YOUR FINGERS.
• Using the other half of the rigid protective liner as a handle, apply the sticky side of the patch to the selected area of the abdomen.

• Press the sticky side of the patch firmly into place.
• Smooth it down.
• While still holding the sticky side down, fold back the other half of the patch.

• Grasp an edge of the remaining protective liner and gently pull it off.
• AVOID TOUCHING THE STICKY SIDE OF THE PATCH WITH YOUR FINGERS.

• Press the entire patch firmly into place with the palm of your hand.
• Continue to apply pressure, with the palm of your hand over the patch, for approximately 10 seconds.

• Make sure that the patch is properly adhered to your skin.
• Go over the edges with your finger to ensure good contact around the patch.

PLEASE NOTE:

• Contact with water while bathing, swimming or showering will not affect the patch.
• In the event that a patch should fall off, AVOID TOUCHING THE STICKY SIDE WITH YOUR FINGERS. Put the same patch back on a different site, making sure to press the patch firmly into place for at least 10 seconds.
• Continue to follow your original twice-a-week schedule you have marked on the inner flap of your individual carton (your calendar card).
• If necessary, if the same patch cannot be reapplied, apply a new patch at another location but continue to follow your original schedule.

5. How to Change and Discard Vivelle-Dot® (estradiol transdermal system)

• When changing the patch, peel off the used patch slowly.
• Fold the used patch in half (sticky sides together) and discard appropriately, in the trash.
• PLEASE KEEP OUT OF THE REACH OF CHILDREN.
• If any adhesive residue remains on your skin after removing the patch, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin.
• Keep in mind, the new patch must be applied to a different area of your abdomen. This area must be clean, dry, cool and free of powder, oil or lotion.

What are the possible side effects of estrogens?

Less common but serious side effects include:

--Breast cancer
--Cancer of the uterus
--Stroke
--Heart attack
--Blood clots
--Dementia
--Gallbladder disease.
--Ovarian cancer

These are some of the warning signs of serious side effects:

--Breast lumps.
--Unusual vaginal bleeding
--Dizziness and faintness
--Changes in speech
--Severe headaches
--Chest pain
--Shortness of breath
--Pains in your legs
--Changes in vision
--Vomiting

Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you

Common side effects include:

--Headache
--Breast pain
--Irregular vaginal bleeding or spotting
--Stomach/abdominal cramps, bloating
--Nausea and vomiting
--Hair loss

Other side effects include:

--High blood pressure
--Liver problems
--High blood sugar
--Fluid retention
--Enlargement of benign tumors of the uterus (“fibroids”)
--Vaginal yeast infection

Other side effects of Vivelle-Dot (estradiol transdermal system) may be possible. If you have questions, talk to your healthcare provider or pharmacist.

What can I do to lower my chances of a serious side effect with Vivelle-Dot (estradiol transdermal system) ?

• Talk with your healthcare provider regularly about whether you should continue taking Vivelle-Dot (estradiol transdermal system) .
• If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
• See your healthcare provider right away if you get vaginal bleeding while taking Vivelle-Dot (estradiol transdermal system) .
• Have a 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.

General information about safe and effective use of Vivelle-Dot (estradiol transdermal system)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Vivelle-Dot (estradiol transdermal system) for conditions for which it was not prescribed. Do not give Vivelle-Dot (estradiol transdermal system) to other people, even if they have the same symptoms you have. It may harm them.

Keep Vivelle-Dot (estradiol transdermal system) out of the reach of children.

This leaflet provides a summary of the most important information about Vivelle-Dot (estradiol transdermal system) . If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Vivelle-Dot (estradiol transdermal system) that is written for health professionals. You can get more information by calling the toll-free number [(888-NOW-NOVA) (888-669-6682)].

What are the ingredients in Vivelle-Dot (estradiol transdermal system) ?

Vivelle-Dot (estradiol transdermal system) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used.

The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.

Other Information

Do not store above 25°C (77°F). Do not store outside of their pouches. Apply immediately upon removal from the protective pouch.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Vivelle-Dot® (estradiol transdermal system) (estradiol transdermal system) for conditions for which it was not prescribed.

Do not give Vivelle-Dot (estradiol transdermal system) to other people, even if they have the same symptoms you have. It may harm them.

Keep this and all drugs out of the reach of children. In case of overdose, remove the system and call your doctor, hospital, or poison control center immediately.

This leaflet summarizes the most important information about Vivelle-Dot (estradiol transdermal system) . If you would like more information, talk to your healthcare provider. You can ask for information about Vivelle-Dot (estradiol transdermal system) that is written for health professionals.

Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.