Menopause and HRT:

Indications for: ALORA

Moderate to severe vasomotor symptoms of menopause. Vulval and vaginal atrophy. Postmenopausal osteoporosis prevention. Hypoestrogenism.

Adult Dosage:

Apply to clean, dry area on lower abdomen, hips, or buttocks (avoid breasts, waistline). Rotate application sites. Osteoporosis: initially 0.025mg/day twice weekly; may increase as needed based on BMD. Others: initially 0.05mg/day twice weekly. Maintenance: use lowest effective dose. Patients without intact uterus may use continuous schedule; otherwise use cyclically (3 weeks on, 1 week off). Transferring from other topical therapy: may start immediately or if from oral estrogens: apply 1st system up to 1 week after last oral dose.

Children Dosage:

Not applicable.

ALORA Contraindications:

Undiagnosed abnormal genital bleeding. Thromboembolic disorders (eg, DVT, PE, stroke, MI). Thrombophlebitis. Breast or other estrogen-dependent neoplasms. Hepatic disease. Pregnancy (Cat.X).

Boxed Warning:

Cardiovascular disorders. Endometrial cancer and breast cancer. Probable dementia.

ALORA 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 events (eg, MI, stroke, VTE); discontinue if occurs. 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. History of hypertriglyceridemia. Discontinue if cholestatic jaundice, hypercalcemia, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Endometriosis. Severe hypocalcemia. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, and BP). Reevaluate periodically. Nursing mothers.

ALORA Classification:


ALORA Interactions:

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).

Adverse Reactions:

Headache, pain, nausea, dyspepsia, dizziness, mastodynia, local irritation, migraine, vaginal bleeding (at 0.1mg/day dose); thromboembolism, neoplasms.



Drug Elimination:

Renal. Half-life: 1.75±2.87 hours.

How Supplied:

Transdermal systems—8