ARIMIDEX

AbsorptionInhibition of aromatase activity is primarily due to anastrozole, the parent drug. Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within 2 hours of dosing under fasted conditions. Studies with radiolabeled drug have demonstrated that orally administered anastrozole is well absorbed into the systemic circulation. Food reduces the rate but not the overall extent of anastrozole absorption. The mean C max of anastrozole decreased by 16% and the median...

14.1 Adjuvant Treatment of Breast Cancer in Postmenopausal Women A multicenter, double-blind trial (ATAC) randomized 9,366 postmenopausal women with operable breast cancer to adjuvant treatment with ARIMIDEX 1 mg daily, tamoxifen 20 mg daily, or a combination of the two treatments for five years or until recurrence of the disease. The primary endpoint of the trial was disease-free survival (i.e., time to occurrence of a distant or local recurrence, or contralateral breast cancer or death from any cause). Secondary endpoints of the trial included distant disease-free survival, the incidence of ...

Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [see A...

Hypersensitivity ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions ( 6.2 )] . Patients with demonstrated hypersensitivity to ARIMIDEX or any excipient ( 4 )

• In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX use compared to tamoxifen use. Consider risks and benefits. ( 5.1 , 6.1 )
• Decreases in bone mineral density may occur. Consider bone mineral density monitoring. ( 5.2 , 6.1 )
• Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.3 , 6.1 )
• Embryo-Fetal Toxicity: ARIMIDEX may cause fetal harm. Advise patients of the potential risk to a ...

7 DRUG INTERACTIONS

• Tamoxifen: Do not use in combination with ARIMIDEX. No additional benefit seen over tamoxifen monotherapy. ( 7.1 , 14.1 )
• Estrogen-containing products: Combination use may diminish activity of ARIMIDEX. ( 7.2 ) 7.1 Tamoxifen Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administratio...