ANASTROZOLE- anastrozole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ANASTROZOLE

Composition:

ANASTROZOLE 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Anastrozole tablets are 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 anastrozole tablets. Anastrozole tablets may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. Anastrozole tablets are contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using anastrozole tablets. If anastrozole is used during pregnancy, or if the patient becomes pregnant

Product summary:

Product: 71335-0023 NDC: 71335-0023-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-2 20 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-3 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-4 4 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-5 6 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-6 10 TABLET, FILM COATED in a BOTTLE NDC: 71335-0023-7 40 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ANASTROZOLE- ANASTROZOLE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANASTROZOLE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANASTROZOLE TABLETS.
ANASTROZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Anastrozole 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
anastrozole (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 anastrozole tablets 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 anastrozole 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 anastrozole tablets 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