Indications 

Vivelle DOT is a transdermal medication prescribed for the following purposes: 

• Managing moderate to severe vasomotor symptoms resulting from menopause 
• Alleviating moderate to severe symptoms associated with vulvar and vaginal atrophy due to menopause 
• Addressing hypoestrogenism stemming from hypogonadism, castration, or primary ovarian failure 
• Preventing postmenopausal osteoporosis 

As an estrogen hormone replacement therapy, Vivelle DOT functions by supplementing the natural estrogen typically produced by the body. 

Uses and Dosage 

Before using Vivelle DOT and with every prescription refill, carefully review its medication guide and patient information leaflet. Do not hesitate to consult with your healthcare provider or pharmacist for any questions or concerns. 

The dosage of Vivelle DOT is individualized, taking into account the patient’s medical condition and their response to the treatment. 

Typically, this patch is affixed to the lower abdomen and should be replaced twice weekly (every 3 to 4 days). The application sites must be alternated, ensuring a minimum one-week interval before reapplying to the same site. 

To properly use Vivelle DOT, follow these steps: 

1. Begin by peeling off the backing from the patch, and adhere it to a clean, dry lower abdomen below the waistline. 
2. Apply gentle but firm pressure to the patch for approximately 10 seconds to ensure it securely adheres. 
   • Avoid applying the patch on the breast or skin that is oily, damaged, or irritated. 
   • Refrain from placing the patch in areas where it could easily rub off, such as the waistline. 
3. When it is time to replace the patch, choose a different location. Allow at least one week before applying a new patch to the same area. 
4. Remove and fold the used patch in half with the sticky sides together and dispose of it in the trash, away from the reach of children and pets. 
   • Do not flush the patch down the toilet. 
5. If the patch falls off, reapply it to a different area. If it does not adhere completely, replace it with a new patch and continue wearing it for the remainder of the scheduled period.  
   • Never wear two patches simultaneously. 

To maximize the benefits of Vivelle-DOT, use it consistently and adhere to a fixed schedule for patch replacement. Keeping a calendar or using reminders can be useful to help you remember your routine. 

Side Effects 

Listed below are the potential adverse effects of Vivelle DOT. If any of these symptoms last or worsen, promptly notify your doctor. 

Common Side Effects 

• Headache, back pain 
• Stuffy nose, sinus pain, sore throat 
• Vaginal itching or discharge, alterations in menstrual periods, breakthrough bleeding 
• Bloating, stomach cramps, nausea, vomiting 
• Breast pain 
• Redness or irritation at the patch application site 
• Thinning scalp hair 
• Fluid retention (swelling, rapid weight gain) 

Serious Side Effects 

• Symptoms of a heart attack: 
  • Chest pain or pressure 
  • Pain radiating to the jaw or shoulder 
  • Nausea 
  • Sweating 
• Signs of increased blood pressure:  
  • Severe headache 
  • Blurred vision 
  • Neck or ear pounding 
  • Anxiety 
  • Nosebleeds 
• Signs of a stroke: 
  • Sudden numbness or weakness, particularly on one side of the body 
  • Sudden severe headache 
  • Slurred speech 
  • Vision or balance issues 
• Indications of a blood clot:  
  • Sudden vision loss 
  • Sharp chest pain 
  • Shortness of breath 
  • Coughing up blood 
  • Leg pain or warmth 
• Abdominal swelling or tenderness 
• Jaundice (yellowing of the skin or eyes) 
• Unusual vaginal bleeding or pelvic pain 
• Breast lump 
• Memory problems, confusion, or unusual behavior 
• Elevated calcium levels in the blood:  
  • Nausea 
  • Vomiting 
  • Constipation 
  • Increased thirst or urination 
  • Muscle weakness 
  • Bone pain 
  • Fatigue 

Remove Vivelle DOT and call your doctor right away should you experience any of the serious side effects listed above. 

Allergic Reactions 

In rare instances, Vivelle DOT may cause a severe allergic reaction. Seek prompt medical help upon observing any indications of an allergic reaction, including: 

• Hives 
• Facial, lips, tongue, or throat swelling 
• Difficulty breathing 

Not all side effects of Vivelle DOT are included in this list. Tell your doctor if any unlisted effects arise. 

Cautions 

Before starting treatment with Vivelle DOT, inform your doctor if you have any known allergies, particularly to estradiol hemihydrate. 

Ask your pharmacist for more details about Vivelle DOT, as it may contain inactive ingredients that may trigger allergic reactions or other complications. 

To ensure Vivelle DOT is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Unexplained vaginal bleeding 
• breast, uterine, or ovarian cancer 
• Blood clots 
• Stroke 
• Heart attack 
• Liver or kidney disease 
• Family medical history (especially related to breast lumps, cancer, or blood clots) 
• Personal or family history of angioedema (a swelling disorder) 
• Blood clotting disorders (e.g., protein C or protein S deficiency) 
• High blood pressure 
• Diabetes 
• High cholesterol/triglycerides levels 
• Obesity 
• Lupus 
• Hypothyroidism (underactive thyroid) 
• Imbalances in blood calcium levels 
• Hypoparathyroidism  
• Uterine issues (such as fibroids or endometriosis) 
• Gallbladder disease 
• Asthma 
• Seizures 
• Migraine headaches 
• Porphyria (a specific blood disorder) 
• Mental/mood disorders (e.g., dementia or depression) 

Disclose all your medication usage, including prescription and over-the-counter drugs, vitamins, and herbal products to your healthcare providers to lower the risk of drug interaction with Vivelle DOT. 

Some of the products that may interact with Vivelle DOT include: 

• Aromatase inhibitors (e.g., anastrozole, exemestane, letrozole) 
• Fezolinetant 
• Fulvestrant 
• Ospemifene 
• Raloxifene 
• Tamoxifen 
• Toremifene 
• Tranexamic acid 

Refrain from consuming grapefruit products, as they can potentially interact with Vivelle DOT and result in undesired side effects. 

Vivelle DOT may disrupt specific lab tests, potentially leading to inaccurate results. Ensure that lab personnel and your medical practitioners know your use of this medication. 

Inform your doctor if you have recently undergone or are scheduled for surgery or anticipate being immobile for an extended period (e.g., during a lengthy flight). These circumstances heighten the likelihood of developing blood clots, particularly when using estrogen-based medications like Vivelle DOT. Temporarily discontinuing this treatment or adopting additional preventive measures may be necessary. 

The application of Vivelle DOT may lead to the development of melasma, characterized by patchy hyperpigmentation on the face and skin. To mitigate this effect, limit sun exposure, refrain from using tanning booths or sunlamps, and employ sunscreen alongside protective attire while outdoors. 

If you are nearsighted or wear contact lenses, you may experience vision issues or difficulties with contact lens wear while using Vivelle DOT. In such cases, reach out to your eye doctor for assistance. 

Children may experience heightened sensitivity to the adverse reactions of Vivelle DOT, potentially impacting their growth and development. Consult the doctor regarding potential effects and regularly assess your child’s growth. 

The use of Vivelle DOT is not recommended during pregnancy. In the event of conception or suspicion of pregnancy, promptly notify your healthcare provider. 

Estradiol hemihydrate can be transferred to breast milk, potentially affecting its quantity and quality. Prior consultation with a healthcare professional is advised before breastfeeding.