Minivelle

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT

Minivelle Generic Name & Formulations

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

Mechanism of Action

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

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, MI, stroke, PE, 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 occurs. 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

Metabolism

Hepatic.

Elimination

Renal. Half-life: 6.2–7.9 hours.

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

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

Mechanism of Action

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

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, MI, stroke, PE, 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 occurs. 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

Metabolism

Hepatic.

Elimination

Renal. Half-life: 6.2–7.9 hours.

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

Images