Blood Clots, Stroke, and Heart Attack
Vivelle-DOT contains estrogen, which can increase the risk of serious blood clots, stroke, and heart attack.
Do not use Vivelle-DOT if you currently have, or have a history of:
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Stroke
- Heart attack
Seek emergency medical attention if you develop sudden chest pain, shortness of breath, weakness or numbness on one side of the body, trouble speaking, or severe leg pain or swelling.
Breast Cancer and Other Estrogen-Sensitive Cancers
Do not use Vivelle-DOT if you have breast cancer, a history of breast cancer, or another known estrogen-dependent cancer.
Long-term estrogen therapy may affect the risk of certain cancers, depending on whether estrogen is used alone or together with a progestogen.
Your healthcare provider will consider your personal and family medical history before recommending treatment.
Endometrial Cancer
If you still have a uterus, using estrogen without a progestogen can increase the risk of abnormal thickening of the uterine lining and endometrial cancer.
Your healthcare provider may prescribe a progestogen along with Vivelle-DOT to help reduce this risk.
Unusual Vaginal Bleeding
Tell your healthcare provider if you develop unusual, unexpected, or persistent vaginal bleeding or spotting.
Vivelle-DOT should not be started if you have unexplained vaginal bleeding until the cause has been evaluated.
Liver Problems
Do not use Vivelle-DOT if you have liver impairment or active liver disease.
The liver helps process estrogen, and impaired liver function can affect how the medication is handled by your body.
Gallbladder Problems
Estrogen therapy can increase the risk of gallbladder disease.
Contact your healthcare provider if you develop severe pain in the upper right side of your abdomen, nausea, vomiting, or yellowing of the skin or eyes.
High Blood Pressure, Diabetes, and High Cholesterol
Tell your healthcare provider if you have:
These conditions can increase the overall risk of heart and blood vessel problems during estrogen treatment.
Smoking
Smoking increases the risk of cardiovascular disease and blood clots.
Tell your healthcare provider if you smoke or use nicotine products, especially if you have other risk factors for blood clots, stroke, or heart disease.
Breast Changes
Follow your healthcare provider’s recommendations for breast examinations and mammograms.
Contact your healthcare provider if you notice:
- A new breast lump
- Persistent breast pain
- Changes in breast shape or skin
- Nipple discharge
Pregnancy
Vivelle-DOT is not intended for use during pregnancy.
Tell your healthcare provider if you become pregnant or think you may be pregnant while using the patch.
Breastfeeding
Tell your healthcare provider if you are breastfeeding.
Estrogen can pass into breast milk and may also reduce milk production, particularly when breastfeeding is being established.
Your healthcare provider can help determine whether Vivelle-DOT is appropriate.
Common Side Effects
Common side effects may include:
- Headache
- Breast tenderness
- Vaginal bleeding or spotting
- Mood changes
- Back pain
- Skin irritation where the patch is applied
Contact your healthcare provider if side effects are severe or persistent.
Do Not Use Extra Estrogen Without Medical Advice
Do not use another estrogen-containing medication or hormone product along with Vivelle-DOT unless your healthcare provider recommends it.
Using additional estrogen may increase your total estrogen exposure and raise the risk of side effects.
Regular Checkups
Your healthcare provider should periodically review whether you still need Vivelle-DOT and whether your dose remains appropriate.
Use the lowest effective dose for the shortest appropriate length of time based on your symptoms and treatment goals.
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