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Minivelle Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal system.
Pharmacological Class
Estrogen.
How Supplied
Transdermal systems—8
Manufacturer
Generic Availability
YES
Minivelle Indications
Indications
Prevention of postmenopausal osteoporosis.
Limitations of Use
Consider only for women at significant risk of osteoporosis and should carefully consider non-estrogen medications.
Minivelle Dosage and Administration
Adult
Apply to clean, dry area on the lower abdomen or buttocks (not to breasts or waist); rotate application sites. Use lowest effective dose and for the shortest duration. Initially one 0.025mg/day patch twice weekly (every 3–4 days); adjust dose as necessary.
Children
Not applicable.
Minivelle Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.
Minivelle Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.
Minivelle Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Pre-existing hypertriglyceridemia. History of cholestatic jaundice. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occur. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers: not recommended.
Minivelle Pharmacokinetics
See Literature
Minivelle Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Minivelle Adverse Reactions
Adverse Reactions
Headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, intermenstrual bleeding; thromboembolism, neoplasms, anaphylaxis.
Minivelle Clinical Trials
See Literature
Minivelle Note
Not Applicable
Minivelle Patient Counseling
See Literature
Minivelle Generic Name & Formulations
Legal Class
Rx
General Description
Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal system.
Pharmacological Class
Estrogen.
How Supplied
Transdermal systems—8
Manufacturer
Generic Availability
YES
Minivelle Indications
Indications
Moderate to severe vasomotor symptoms of menopause.
Minivelle Dosage and Administration
Adult
Apply to clean, dry area on the lower abdomen or buttocks (not to breasts or waist); rotate application sites. Use lowest effective dose and for the shortest duration. Initially one 0.0375mg/day patch twice weekly (every 3–4 days). Attempt to taper or discontinue at 3–6 month intervals.
Children
Not applicable.
Minivelle Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.
Minivelle Boxed Warnings
Boxed Warning
Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.
Minivelle Warnings/Precautions
Warnings/Precautions
Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Pre-existing hypertriglyceridemia. History of cholestatic jaundice. Discontinue if cholestatic jaundice, pancreatitis, or hypercalcemia occur. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers: not recommended.
Minivelle Pharmacokinetics
See Literature
Minivelle Interactions
Interactions
May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). May be antagonized CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John's wort). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).
Minivelle Adverse Reactions
Adverse Reactions
Headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, intermenstrual bleeding; thromboembolism, neoplasms, anaphylaxis.
Minivelle Clinical Trials
See Literature
Minivelle Note
Not Applicable
Minivelle Patient Counseling
See Literature
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