Minivelle

Minivelle is a prescription medication used to treat symptoms of menopause including hot flashes. It is also used to treat prevent osteoporosis in women after menopause. 

Minivelle contains estradiol which is a form of the hormone estrogen. It replaces estrogen that is not naturally produced by the ovaries.

This medication comes is available as a transdermal patch. It is usually applied twice a week. 

Common side effects of Minivelle include headache, breast tenderness, and back pain.

Minivelle is a prescription medication used to treat symptoms of menopause including hot flashes. It is also used to treat prevent osteoporosis in women after menopause. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Noven Therapeutics, Llc

Serious side effects have been reported with Minivelle. See the “Minivelle Precautions” section.

Common side effects of Minivelle include the following:

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

This is not a complete list of Minivelle side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin 
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Minivelle drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Minivelle including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not use Minivelle if you:

• are allergic to Minivelle or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently or have a history of blood clots
• have had a recent heart attack or stroke
• have liver disease
• have been diagnosed with a bleeding disorder
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with Minivelle and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Minivelle, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Minivelle or to any of its ingredients
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• currently or have a history of blood clots
• have had a recent heart attack or stroke
• are going to have surgery or will be on bed rest
• have conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of the face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Minivelle should not be used during pregnancy. There appears to be little or no increased risk of birth defects in children born to women who inadvertently used estrogens during early pregnancy. Talk to your doctor right away if you become pregnant while using Minivelle.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Estrogen has been detected in human breast milk. Estrogen can decrease the quality or quantity of breast milk. Caution should be taken when Minivelle is given to a nursing woman. 

Use Minivelle exactly as prescribed.

This medication is available as a transdermal patch. It is usually applied twice a week.

• Use Minivelle exactly as your healthcare provider tells you to use it
• Minivelle is for skin use only
• Change your Minivelle patch 2 times a week or every 3 to 4 days
• Apply your Minivelle patch to a clean, dry area on your lower abdomen or buttocks. This area must be clean, dry, and free of powder, oil or lotion for your patch to stick to your skin
• Apply your v patch to a different area of your abdomen or your buttocks each time. Do not use the same application site 2 times in the same week.
• Do not apply Minivelle to your breasts
• If you forget to apply a new Minivelle patch, you should apply a new patch as soon as possible.
• You and your healthcare provider should talk regularly (every 3 to 5 months) about your dose and whether you still need treatment with Minivelle.

How to Change Minivelle:

• When changing the patch, peel off the used patch slowly from the skin
• After removal of Minivelle, 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 abdomen or buttocks. This area must be clean, dry, cool and free of powder, oil or lotion.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Minivelle (estradiol) transdermal patches for the treatment of menopause symptoms is 0.0375 mg per day applied to the skin twice weekly. 

The recommended starting dose of Minivelle (estradiol) transdermal patches for the prevention of osteoporosis in women after menopause is 0.025 mg per day applied to the skin twice weekly. 

Dose may be adjusted as needed. 

If you use too much Minivelle, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Minivelle is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Minivelle at room temperature.
• Do not store Minivelle patches outside of their pouches. Apply immediately upon removal from the protective pouch
• Keep this and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, AND PROBABLE DEMENTIA 

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Estrogen-Alone Therapy

• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens 
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia 
• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) 
• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older 

Estrogen Plus Progestin Therapy

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia 
• The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke, and myocardial infarction (MI) 
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer 
• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older