Vivelle-Dot: Uses, Side Effects and Dosage

What is the most important information I should know about Vivelle-Dot (an estrogen hormone)?

• 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 and older.
• Do not use estrogens with progestogens to prevent heart disease, heart attacks, strokes, or dementia.
• Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
• Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.

• Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, blood clots, and dementia.

  Because other products and doses have not been studied in the same way, it is not known how the use of Vivelle-Dot will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Vivelle-Dot.

What is Vivelle-Dot?

Vivelle-Dot is a prescription medicine patch (transdermal system) that contains the estrogen hormone estradiol. When applied to the skin, estradiol is absorbed through the skin into the bloodstream.

1. What is Vivelle-Dot used for?

   Vivelle-Dot is used after menopause to:

2. • Reduce moderate to severe hot flashes

3. 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 estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden intense feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe.

4. • Treat moderate to severe menopausal changes in and around the vagina
5. 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.
6. • Treat certain conditions in women before menopause if their ovaries do not produce enough estrogens naturally
7. •

   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 to prevent osteoporosis due to 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.

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.

• have been diagnosed with a bleeding disorder

• 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 (womb). 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
• are allergic to Vivelle-Dot or any of the ingredients in it. See the list of ingredients in Vivelle-Dot at the end of this leaflet.

Before you use Vivelle-Dot, tell your healthcare provider about all of your medical conditions, including 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 that may become worse while you are using Vivelle-Dot

  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); 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 pregnant or think you may be pregnant.

  Vivelle-Dot is not for pregnant women.

• 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 over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Vivelle-Dot works. Vivelle-Dot may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.

How should I use Vivelle-Dot?

For detailed instructions, see the step-by-step instructions for using Vivelle-Dot at the end of this Patient Information.

• 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 on 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, 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 if any adhesive residue remains on your skin, allow the area to dry for 15 minutes. Then, gently rub the area with oil or lotion to remove the adhesive from your skin.
• Apply the new patch 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
• breast cancer
• cancer of the lining of the uterus (womb)
• cancer of the ovary
• dementia
• high or low blood calcium
• gallbladder disease
• visual abnormalities

• high blood pressure
• high levels of fat (triglyceride) in your blood
• liver problems
• changes in your thyroid hormone levels
• fluid retention
• cancer changes of endometriosis
• enlargement of benign tumors of the uterus (“fibroids”)
• worsening of swelling of face and tongue (angioedema) in women with a history of angioedema

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
• swelling of face and tongue with or without red, itchy bumps

Common side effects of Vivelle-Dot 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. Tell your healthcare provider if you have any side effects that bother you or do not go away.

You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Sandoz Inc. at 1-800-525-8747.

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 progestogen is right for you. In general, the addition of a progestogen is 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.

How should I store and throw away used Vivelle-Dot patches?

• Store Vivelle-Dot 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.

  General information about safe and effective use of Vivelle-Dot

  Medicines are sometimes prescribed for purposes other than those listed 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.

  You can ask your healthcare provider or pharmacist for information about Vivelle-Dot that is written for health professionals. For more information go to www.sandoz.com or call 1-800-525-8747.

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.

Mfd. by: Noven Pharmaceuticals, Inc.

Miami, FL 33186 for

1. Sandoz Inc., Princeton, NJ 08540

1. This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: November 2023

INSTRUCTIONS FOR USE

Vivelle-Dot^® (vī-VEL-dot)

(estradiol transdermal system)

Read this Instructions for Use before you start using Vivelle-Dot and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.

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

Decide upon which 2 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 2-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).

1. 2. Where to Apply Vivelle-Dot

Apply patch to a dry area of the skin of the trunk of the body, including the lower abdomen, or buttocks. 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 1 week.

1. 3. Before You Apply Vivelle-Dot

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

1. 4. How to Apply Vivelle-Dot

	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 the 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 or buttocks.
	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.

Note:

• Showering will not cause your patch to fall off.
• If your patch falls off reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your original placement schedule.
• If you stop using your Vivelle-Dot patch or forget to apply a new patch as scheduled, you may have spotting, or bleeding, and recurrence of symptoms.
• Throwing Away Your Used Patch
• When it is time to change your patch, remove the old patch before you apply a new patch.
• To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. Used patches should not be flushed in the toilet.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Mfd. by: Noven Pharmaceuticals, Inc.

Miami, FL 33186 for

Sandoz Inc., Princeton, NJ 08540

Revised: November 2023

100922-15-US