Clinical Experience & Use
Dosing
Dosage and administration
Dosage
The dose of Arimidex is one 1-mg tablet taken once a day. For patients with advanced breast cancer, Arimidex should be continued until tumor progression.
For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC clinical trial, Arimidex was administered for 5 years.10
Patients with hepatic impairment10
See DOSAGE AND ADMINISTRATION and USE IN SPECIAL POPULATIONS in the CLINICAL PHARMACOLOGY section of the full Prescribing Information. No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Arimidex has not been studied in patients with severe hepatic impairment.
Plasma anastrozole concentrations in the subjects with hepatic cirrhosis were within the range of concentrations seen in normal subjects across all clinical trials. Therefore, dosage adjustment is also not necessary in patients with stable hepatic cirrhosis.
Patients with renal impairment
No changes in dose are necessary for patients with renal impairment.10
Use in the elderly
No dosage adjustment is necessary for elderly patients.10
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 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.
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)
- 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
Please click here for full Prescribing Information.