Vivelle-Dot

What is Vivelle-Dot?

Vivelle-Dot is a prescription medicine patch (Transdermal System) that contains estradiol (an estrogen hormone). When applied to the skin as directed below, Vivelle-Dot releases estrogen through the skin into the bloodstream.

What is Vivelle-Dot used for?

Vivelle-Dot 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.
• Treat moderate to severe menopausal changes in and around the vagina
  You and your healthcare provider should talk regularly about whether you still need treatment with Vivelle-Dot to control these problems. If you use Vivelle-Dot only to treat your menopausal changes 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 women before menopause if their 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 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 treatment with Vivelle-Dot.

What is the most important information I should know about Vivelle-Dot?

• Using estrogen-alone increases your chance of getting cancer of the uterus (womb).
  Report any unusual vaginal bleeding right away while you are using Vivelle-Dot. 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 in 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 Vivelle-Dot.

Who should not use Vivelle-Dot?

Do not start using Vivelle-Dot if you:

• have 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.
• 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 Vivelle-Dot.
• 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 Vivelle-Dot or any of its ingredients
  See the list of ingredients in Vivelle-Dot at the end of this guide.
• think you may be pregnant
  Vivelle-Dot is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Vivelle-Dot if the test is positive and talk to your healthcare provider.

What should I tell my healthcare provider before using Vivelle-Dot?

Before you use Vivelle-Dot, 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.
• have any other medical conditions
  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, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• are going to have surgery or will be on bed rest
  Your healthcare provider will let you know if you need to stop using Vivelle-Dot.
• are breastfeeding
  The hormone in Vivelle-Dot can pass into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vivelle-Dot works. Vivelle-Dot may also affect how other medicines work.

How should I use Vivelle-Dot?

For detailed instructions, see the step-by-step instructions that come with Vivelle-Dot .

• Use Vivelle-Dot exactly as your healthcare provider tells you to use it.
• Vivelle-Dot is for skin use only.
• Change your Vivelle-Dot patch 2 times a week or every 3 to 4 days.
• Apply your Vivelle-Dot patch to a clean, dry area of your lower abdomen. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin.
• Apply your Vivelle-Dot patch to a different area of your abdomen each time. Do not use the same application site 2 times in the same week.
• Do not apply Vivelle-Dot to your breasts.
• If you forget to apply a new Vivelle-Dot patch, you should apply a new patch as soon as possible.
• You and your healthcare provider should talk regularly (every 3 to 6 months) about your dose and whether you still need treatment with Vivelle-Dot.

How to Change Vivelle-Dot

• When changing the patch, peel off the used patch slowly from the skin.
• After removal of Vivelle-Dot, patients usually have either no adhesive residue or light adhesive residue. 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 lower abdomen. This area must be clean, dry, cool and free of powder, oil, or lotion.

What are the possible side effects of Vivelle-Dot?

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
• changes in your thyroid hormone levels
• enlargement of benign tumors (“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
• nipple discharge
• 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
• swelling
• rash

Less serious, but common side effects include:

• headache
• breast pain
• irregular vaginal bleeding or spotting
• painful periods
• stomach or abdominal cramps, bloating
• nausea and vomiting
• hair loss
• fluid retention
• vaginal yeast infection
• redness and/or irritation at patch placement site

These are not all the possible side effects of Vivelle-Dot. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Novartis Pharmaceuticals Corporation (1-888-NOW-NOVA or 1-888-669-6682).

What can I do to lower my chances of getting a serious side effect with Vivelle-Dot?

• Talk with your healthcare provider regularly about whether you should continue using Vivelle-Dot.
• If you have a uterus, talk to 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 (womb).
• See your healthcare provider right away if you get vaginal bleeding while using Vivelle-Dot.
• 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.

General information about the safe and effective use of Vivelle-Dot

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

This guide provides a summary of the most important information about Vivelle-Dot. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about Vivelle-Dot that is written for health professionals. For more information, call the toll-free number Novartis Pharmaceuticals Corporation (1-888-NOW-NOVA or 1-888-669-6682).

How should I store Vivelle-Dot?

• Store at room temperature 68°F to 77°F (20°C to 25°C)
• Do not store Vivelle-Dot patches outside of their pouches. Apply immediately upon removal from the protective pouch.
• Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet.

Keep Vivelle-Dot and all medicines out of the reach of children.

What are the ingredients in Vivelle-Dot?

Active ingredient: estradiol

Inactive ingredients: a translucent polyolefin film, acrylic and silicone adhesives, oleyl alcohol, NF, povidone, USP, dipropylene glycol and a polyester release liner.