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:

Aurobindo Pharma Limited

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)]. - Pregnancy: Letrozole can   caus

Product summary:

Letrozole Tablets USP 2.5 mg are dark yellow, film-coated, round, slightly biconvex, with beveled edges debossed with ‘L2.5’ on one side and plain on other side. They are supplied as follows: Bottles of 30        NDC 59651-180-30 Bottles of 90        NDC 59651-180-90 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LETROZOLE - LETROZOLE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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
Contraindications (4) 7/2017
Warnings and Precautions, Embryo-Fetal Toxicity (5.6) 7/2017
INDICATIONS AND USAGE
Letrozole is an aromatase inhibitor indicated for:
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)
DOSAGE AND ADMINISTRATION
Letrozole tablets are taken orally without regard to meals (2):
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)
DOSAGE FORMS AND STRENGTHS
2.5 mg tablets (3)
CONTRAINDICATIONS
Pregnancy (4)
Known hypersensitivity to the active substance, or to any of the
excipients (4)
WARNINGS AND PRECAUTIONS
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 caution when
operating machinery (5.4)
Embryo-Fetal toxicity: Can cause fetal harm when administered to
pregnant women. Obtain a pregnancy test in females
of reproductive potential. Advise females of reproductive potential to
use effective contraception (5.6, 8.1, 8.3)
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 SUSPE