LETROZOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LETROZOLE (UNII: 7LKK855W8I) (LETROZOLE - UNII:7LKK855W8I)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. Letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies (14.2, 14.3) ]. Letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see Clinical Studies (14.4, 14.5) ]. Risk Summary Based on postmarketing reports, findings from animal studies and the mechanism of act

Product summary:

Letrozole Tablets USP, 2.5 mg are available as follows: 2.5 mg – dark-yellow, standard convex round, unscored, film-coated tablets, debossed with “TEVA” on one side and “B1” on the other side of the tablet, in bottles of 30 (NDC 71205-587-30), bottles of 60 (NDC 71205-587-60), and bottles of 90 (NDC 71205-587-90). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LETROZOLE- LETROZOLE TABLET, FILM COATED
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LETROZOLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LETROZOLE
TABLETS.
LETROZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Letrozole tablets are an aromatase inhibitor indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
Letrozole tablets are taken orally without regard to meals (2):
•
•
DOSAGE FORMS AND STRENGTHS
2.5 mg tablets (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (greater than 20%) were hot flashes,
arthralgia; flushing, asthenia,
edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating
increased, bone pain; and
musculoskeletal (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS
USA, INC. AT 1-
888-838-2872 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2021
Contraindications (4) 7/2017
Warnings and Precautions, Embryo-Fetal Toxicity (5.6) 7/2017
Adjuvant treatment of postmenopausal women with hormone receptor
positive early breast cancer
(1.1)
Extended adjuvant treatment of postmenopausal women with early breast
cancer who have received
prior standard adjuvant tamoxifen therapy (1.2)
First and second-line treatment of postmenopausal women with hormone
receptor positive or
unknown advanced breast cancer (1.3)
Recommended dose: 2.5 mg once daily (2.1)
Patients with cirrhosis or severe hepatic impairment: 2.5 mg every
other day (2.5, 5.3)
Pregnancy (4)
Known hypersensitivity to the active substance, or to any of the
excipients (4)
Decreases in bone mineral density may occur. Consider bone mineral
density monitoring (5.1)
Increases in total cholesterol may occur. Consider cholesterol
monitoring. (5.2)
Fatigue, dizziness and somnolence may occur. Exercise cau