ARIMIDEX- anastrozole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

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. Hypersensitivity ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions (6.2)] . Risk Summary Based on findings from animal studies and its mechanism of action, ARIMIDEX may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no studies of A

Product summary:

ARIMIDEX (anastrozole) Tablets, 1 mg are supplied in bottles of 30 tablets (NDC 62559-670-30). Storage Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP].

Authorization status:

New Drug Application

Summary of Product characteristics

ARIMIDEX- ANASTROZOLE TABLET
ANI PHARMACEUTICALS, 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
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo Fetal Toxicity (5.4) 12/2018
INDICATIONS AND USAGE
ARIMIDEX is an aromatase inhibitor indicated for:
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DOSAGE AND ADMINISTRATION
One 1 mg tablet taken once daily (2.1)
DOSAGE FORMS AND STRENGTHS
1 mg tablets (3)
CONTRAINDICATIONS
Patients with demonstrated hypersensitivity to ARIMIDEX or any
excipient (4)
WARNINGS AND PRECAUTIONS
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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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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®
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 pat