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
Faslodex Warnings, Precautions, Pregnancy, Nursing, Abuse - Fulvestrant
Faslodex Warnings, Precautions, Pregnancy, Nursing, Abuse - Fulvestrant
WARNINGS
Women of childbearing potential should be advised not to become
pregnant while receiving FASLODEX. FASLODEX can cause fetal harm when administered
to a pregnant woman and has been shown to cross the placenta following single
intramuscular doses in rats and in rabbits. In studies in the pregnant rat,
intramuscular doses of fulvestrant 100 times lower than the maximum recommended
human dose (based on body surface area [BSA]), caused an increased incidence
of fetal abnormalities and death. Similarly, rabbits failed to maintain pregnancy
and the fetuses showed an increased incidence of skeletal variations when fulvestrant
was administered at one-half the recommended human dose (based on BSA).
There are no studies in pregnant women using Faslodex. If FASLODEX
is used during pregnancy or if the patient becomes pregnant while receiving
this drug, the patient should be apprised of the potential hazard to the fetus,
or potential risk for loss of the pregnancy. See Pregnancy section of
PRECAUTIONS
.
Because FASLODEX is administered intramuscularly, it should
not be used in patients with bleeding diatheses, thrombocytopenia or patients
on anticoagulants.
PRECAUTIONS
General
Before starting treatment with FASLODEX, pregnancy must be
excluded (see WARNINGS
).
Hepatic Impairment
Safety and efficacy have not been evaluated in patients with
moderate to severe hepatic impairment (see CLINICAL
PHARMACOLOGY-Hepatic Impairment and DOSAGE
AND ADMINISTRATION-Hepatic Impairment sections).
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