HIGHLIGHTS OF PRESCRIBING INFORMATION

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AstraZeneca Pharmaceuticals LP

INN (Διεθνής Όνομα):

ANASTROZOLE

Σύνθεση:

ANASTROZOLE 1 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 a

Περίληψη προϊόντος:

These tablets are supplied in bottles of 30 tablets (NDC 0310-0201-30). Store at controlled room temperature, 20-25°C (68-77°F) [see USP].

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

ARIMIDEX- ANASTROZOLE TABLET
ASTRAZENECA PHARMACEUTICALS LP
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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:
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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
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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 ASTRAZENECA
PHARMACEUTICALS LP AT 1-800-236-9933 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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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2014
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 rarel