A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Femara Indications, Dosage, Storage, Stability - Letrozole
Femara Indications, Dosage, Storage, Stability - Letrozole
INDICATIONS
Femara® (letrozole tablets) is indicated for the extended adjuvant treatment of early breast cancer in postmenopausal
women who have received 5 years of adjuvant tamoxifen therapy (see CLINICAL STUDIES). The effectiveness of Femara in
extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated
for a median of 24 months (see CLINICAL PHARMACOLOGY Clinical Studies subsection). Further data will be required to
determine long-term outcome.
Femara® (letrozole tablets) is indicated for first-line treatment of postmenopausal women with hormone receptor
positive or hormone receptor unknown locally advanced or metastatic breast cancer. Femara is also indicated for the
treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
DOSAGE AND ADMINISTRATION
Adult and Elderly Patients
The recommended dose of
Femara (letrozole tablets) is one 2.5 mg
tablet administered once a day, without regard to meals. Treatment
with Femara should continue until tumor
progression is evident.
No dose
adjustment is required for elderly patients. Patients treated with
Femara do not require glucocorticoid or mineralocorticoid
replacement therapy.
Renal Impairment
(See CLINICAL PHARMACOLOGY.)
No dosage adjustment
is required for patients with renal
impairment if creatinine
clearance is ³ 10 mL/ min.
Hepatic Impairment
(See CLINICAL PHARMACOLOGY.)
Although letrozole blood
concentrations were modestly increased in subjects with moderate
hepatic impairment
due to cirrhosis,
no dosage
adjustment is recommended
for patients with mild- to- moderate hepatic
impairment. Patients with severe impairment
of liver function
have not been studied. Because letrozole is eliminated almost exclusively
by hepatic metabolism,
patients with severe impairment of liver
function should be
dosed with caution.
HOW SUPPLIED
2,5 mg tablets - dark yellow,
film-coated, round, slightly biconvex, with beveled edges (imprinted
with the letters FV on one side
and CG on the other side).
Packaged in HDPE bottles with a safety screw cap. Bottles of 30
tablets............................ NDC 0078-0249-15
Store at 25º C (77º F); excursions permitted to 15º
C-30º C (59º F-86º F) (see USP Controlled Room Temperature)
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