ARIMIDEX(anastrozole) tablet - America[美国药品]

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ARIMIDEX(anastrozole) tablet

2016-07-05 09:15:07 来源: 作者: 【大中小】浏览:267次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ARIMIDEX safely and effectively. See full prescribing information for ARIMIDEX.
ARIMIDEX® (anastrozole) tablet for oral use
Initial U.S. Approval: 1995

INDICATIONS AND USAGE

ARIMIDEX is an aromatase inhibitor indicated for:

•: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1)
•: First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2)
•: Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX ( 1.3)

DOSAGE AND ADMINISTRATION

One 1 mg tablet taken once daily (2.1)

DOSAGE FORMS AND STRENGTHS

1 mg tablets (3)
CONTRAINDICATIONS

•: Women of premenopausal endocrine status, including pregnant women ( 4.1, 8.1)
•: Patients with demonstrated hypersensitivity to ARIMIDEX or any excipient ( 4.2)

WARNINGS AND PRECAUTIONS

•: 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)

ADVERSE REACTIONS

In the early breast cancer (ATAC) study, the most common (occurring with an incidence of ≥10%) side effects occurring in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema and lymphedema, regardless of causality. (6.1)

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. (6.1)