Important
Information About 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 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
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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Prescribing Information
Important Information About
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 About 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.
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Prescribing Information
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