ARIMIDEX® (anastrozole) Tablets
FASLODEX® (fulvestrant) Injection
ARIMIDEX® (anastrozole) Tablets
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.
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 ATAC 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 often 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 flushes (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 use with ARIMIDEX
as they may diminish its pharmacologic action.
Please see full Prescribing Information
FASLODEX® (fulvestrant) Injection
FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Important Safety Information for FASLODEX
FASLODEX is only for postmenopausal women. FASLODEX can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant while receiving FASLODEX. (See CONTRAINDICATIONS and WARNINGS sections of full Prescribing Information.)
Because FASLODEX is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants.
In clinical trials, the most commonly reported adverse events seen with FASLODEX, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (nausea 26.0%, vomiting 13.0%, constipation 12.5%, diarrhea 12.3%, abdominal pain 11.8%), headache (15.4%), back pain (14.4%), hot flushes (17.7%), and pharyngitis (16.1%). Injection site reactions with mild, transient pain and inflammation were reported in 7% of patients (1% of treatments) given single 5 mL injection and 27% of patients (4.6% of treatments) given 2 x 2.5 mL injections of FASLODEX.
Please see full Prescribing Information