ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with estrogen receptor-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.
ARIMIDEX is only for postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment with ARIMIDEX, pregnancy must be excluded (see CONTRAINDICATIONS section of full Prescribing Information).
In women with preexisting ischemic heart disease 465/6186 (7.5%), an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX (17%) vs tamoxifen (10%). In this patient population, angina pectoris was reported in 25/216 (11.6%) vs 13/249 (5.2%) and myocardial infarction was reported in 2/216 (0.9%) vs 8/249 (3.2%) patients receiving ARIMIDEX and tamoxifen, respectively.
Compared to baseline, ARIMIDEX showed a mean decrease in both lumbar spine and total hip bone mineral density. Tamoxifen showed a mean increase in these measurements. Nine percent of patients receiving ARIMIDEX had an elevated serum cholesterol vs 3.5% of patients receiving tamoxifen.
Common side effects seen with ARIMIDEX vs tamoxifen in the early breast cancer trial after 5 years of treatment include hot flashes (36% vs 41%), joint disorders (including arthritis, arthrosis, arthralgia) (36% vs 29%), asthenia (19% vs 18%), mood disturbances (19% vs 18%), pain (17% vs 16%), pharyngitis (14% vs 14%), nausea and vomiting (13% vs 12%), rash (11% vs 13%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis (11% vs 7%), peripheral edema (10% vs 11%), lymphedema (10% vs 11%), back pain (10% vs 10%), insomnia (10% vs 9%), and headache (10% vs 8%). Fractures, including fractures of the spine, hip, and wrist, occurred more often with ARIMIDEX vs tamoxifen (10% vs 7%).
In the advanced breast cancer studies, the most common (occurring with an incidence of >10%) side effects occurring in women taking ARIMIDEX included hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema. Joint pain/stiffness has been reported in association with the use of ARIMIDEX.
Clinical and pharmacokinetic results suggest that tamoxifen should not be administered with ARIMIDEX. Estrogen-containing therapies should not be used with ARIMIDEX as they may diminish its pharmacologic action.
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