ARIMIDEX- anastrozole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ANASTROZOLE

Composition:

ANASTROZOLE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX. ARIMIDEX may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. ARIMIDEX is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using ARIMIDEX. If ARIMIDEX is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to

Product summary:

These tablets are supplied in bottles of 30 tablets (NDC 54868-5000-0 ). Store at controlled room temperature, 20-25°C (68-77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

ARIMIDEX - ANASTROZOLE TABLET
PHYSICIANS TOTAL CARE, INC.
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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 advance