Vivelle-Dot

The active ingredient in Vivelle-Dot is estradiol. Vivelle-Dot utilizes a unique transdermal delivery system to release a controlled amount of estradiol into the bloodstream. The patch adheres to the skin and gradually releases the hormone, mimicking the natural hormone production in a woman's body.

The estradiol in Vivelle-Dot is absorbed through the skin and enters the bloodstream, where it helps to alleviate the symptoms of menopause. By replenishing estrogen levels, Vivelle-Dot restores hormonal balance, reducing hot flashes, night sweats, and other uncomfortable symptoms.

The continuous and steady release of hormones provided by Vivelle-Dot ensures a more consistent hormonal environment, reducing the fluctuations that can contribute to mood swings and emotional instability.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Vivelle-Dot. However, the following is a synopsis of the general guidelines for the use of Vivelle-Dot:

• Choose the application site: Vivelle-Dot is usually applied to clean, dry skin on the lower abdomen, below the waistline, or on the upper buttock area. Rotate the application site with each new patch to minimize skin irritation.
• Clean the skin: Before applying Vivelle-Dot, clean the chosen area with mild soap and water. Do not use any creams, lotions, or oils on the skin where the patch will be applied.
• Open the pouch: Carefully tear open the pouch containing the patch. Avoid touching the sticky side of the patch to prevent any contamination.
• Apply the patch: Peel off the protective liner from the patch and apply it firmly to the chosen site. Press down on the patch for about 10 seconds to ensure proper adhesion.
• Dispose of used patches: After wearing the patch for the recommended duration (usually 3-4 days), remove it and fold it in half with the sticky sides together. Dispose of the used patch safely, out of reach of children and pets.
• Continued exams: Have a breast exam, pelvic exam, and mammogram every year unless your healthcare provider.

The most common side effects of Vivelle-Dot seen in clinical trials as compared to placebo include:

• Back pain
• Depression
• Spotting or irregular vaginal bleeding
• Upper respiratory tract infection
• Sinus headache
• Nasopharyngitis
• Bloating
• Sinusitis
• Breast tenderness
• Headache
• Breast pain
• Breast enlargement

Some individuals may experience serious side effects while using Vivelle-Dot. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Unusual vaginal bleeding
• Such as breakthrough bleeding or prolonged/recurring bleeding.
• This could be a sign of cancer of the womb
• Heart attack
• Increased blood pressure
• Signs of a blood clot
• Jaundice
• Memory problems, confusion, unusual behavior
• Sudden, severe headache
• Severe hypercalcemia
• New breast lumps
• Severe allergic reaction. Symptoms could include:
• Hives
• Swelling of the lips or face
• Trouble breathing

These are not all of the possible side effects of Vivelle-Dot. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Vivelle-Dot, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of unexplained vaginal bleeding
• Liver disease
• Breast cancer or cancer of the ovaries
• Blood clots or blood clotting disorders (including protein C or protein S)
• Known angioedema
• This is contradicted with Vivelle-Dot
• Gallbladder disease
• Migraine headaches
• Endometriosis
• Asthma
• Lupus
• Hepatic impairment or disease
• Epilepsy
• High levels of calcium in your blood
• Hereditary angioedema
• Conditions that may predispose to fluid retention
• Porphyria
• Underactive thyroid (hypothyroidism)
• High blood pressure
• High cholesterol or triglycerides
• Obesity

Boxed Warning

There is a boxed warning for Vivelle-Dot that includes cardiovascular disorders, endometrial cancer, breast cancer, and probable dementia.

For estrogen-alone therapy:

• An increased risk of endometrial cancer in any woman who has a uterus and uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to lower the risk of endometrial hyperplasia.
• There was a Women’s Health Initiative (WHI) estrogen-alone substudy that reported an increased risk of deep vein thrombosis (DVT) and stroke.
• The WHI Memory Study, otherwise known as the WHIMS estrogen-alone ancillary study of WHI had reported an increased risk of developing probable dementia in any postmenopausal women who are 65 years of age or older.
• Estrogen-alone therapy should not be used for the prevention of dementia or cardiovascular disease.

Estrogen plus progestin therapy:

• The WHI estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), myocardial infarction (MI), DVT, and stroke.
• The WHI estrogen plus progestin substudy reported an increased risk of breast cancer.
• WHIMS estrogen plus progestin ancillary study of WHI had reported an increased risk of developing probable dementia in women 65 years of age or older and postmenopausal.
• Estrogen plus progestogen therapy is used for the prevention of dementia and cardiovascular disease.

• Abnormal genital bleeding that has gone undiagnosed
• Past or present diagnosis of breast cancer
• Estrogen-dependent neoplasia
• Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
• Active deep vein thrombosis (DVT), pulmonary embolism (PE), past or present.
• Active arterial thromboembolic disease (for example stroke or myocardial infarction), past or present.
• Hepatic impairment or related disease
• Known hypersensitivity to Vivelle-Dot

Vivelle-Dot typically starts alleviating menopause symptoms, such as hot flashes and night sweats, within a few days to a week. For conditions like vaginal atrophy or osteoporosis prevention, noticeable effects may take several weeks or longer.

When Vivelle-Dot is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Inhibitors or inducers of CYP3A4
• It may affect estrogen drug metabolism and increase or decrease the estrogen plasma concentration.
• Examples: St. John’s wort, erythromycin, phenobarbital, carbamazepine, rifampin, or grapefruit juice

Vivelle-Dot comes as a transdermal system that includes the following dosage forms:

• 0.025 mg/day
• 0.0375 mg/day
• 0.05 mg/day
• 0.075 mg/day
• 0.1 mg/day

Store at room temperature, otherwise known as 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F).

Vivelle-Dot is manufactured by Novartis Pharmaceuticals Corporation.

Currently, generics are available for Vivelle-Dot.

To stop using Vivelle-Dot, consult your doctor, who may recommend gradually tapering the dose to avoid withdrawal symptoms and the return of menopause-related issues. Monitor your symptoms during this process and adopt supportive lifestyle changes, such as a healthy diet and exercise, to ease the transition.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Pregnancy is considered a contraindication by Vivelle-Dot. Do not use this medication if you are pregnant.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Estradiol can slow your milk production; tell your doctor if you are breastfeeding.