Safety & Tolerability—

In initial adjuvant therapy...

Established 5+-year safety profile through treatment completion

68-month ATAC trial safety results analysis

1. ATAC Trialists’ Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-62.

Through 68-month follow-up, drug-related adverse events were seen in 61% of patients on ARIMIDEX versus 68% of patients on tamoxifen²

Important Safety Information

1. ATAC Trialists’ Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-62.

* Patients with multiple events in the same category were counted only once in that category.

† Percentages calculated based on numbers of patients with intact uterus at baseline.

Important Safety Information

2. The Arimidex, Tamoxifen, Alone or in Combination(ATAC) Trialists’ Group. Comprehensive side-effect profile of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: long-term safety analysis of the ATAC trial. Lancet Oncol. 2006;7(8):633-643.

* Patients with multiple events in the same category were counted only once in that category.

† The observed difference was associated with a subgroup of patients with pre-existing ischemic heart disease.

‡ P=NA. No statistical analysis was performed.

Important Safety Information

1. ATAC Trialists’ Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet. 2005;365(9453):60-62.

* Patients with multiple events in the same category were counted only once in that category.

† Refers to joint symptoms, including joint disorders, arthritis, arthrosis, and arthralgia.

Important Safety Information

Important Information About ARIMIDEX Tablets

ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer.

ARIMIDEX is indicated 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.

Important Safety Information About 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 WARNINGS section of full Prescribing Information).

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%), depression (13% vs 12%), hypertension (13% vs 11%), osteoporosis (11% vs 7%), peripheral edema (10% vs 11%), and headache (10% vs 8%). Fractures, including fractures of the spine, hip, and wrist, occurred more frequently with ARIMIDEX vs tamoxifen (10% vs 7%).

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.

The common side effects seen with ARIMIDEX in advanced breast cancer trials include hot flashes (26.5%), nausea (18.6%), asthenia (16.4%), pain (13.8%), back pain (11.9%), bone pain (10.7%), and increased cough (10.9%). 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.

Please click here for full Prescribing Information.

ARIMIDEX is a registered trademark of the AstraZeneca group of companies.