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
Cetrotide Side Effects, and Drug Interactions - Cetrorelix
Cetrotide Side Effects, and Drug Interactions - Cetrorelix
SIDE EFFECTS
The safety of Cetrotide® (cetrorelix acetate
for injection) in 949 patients undergoing controlled ovarian stimulation in
clinical studies was evaluated. Women were between 19 and 40 years of age (mean:
32). 94.0 % of them were Caucasian. Cetrotide® was given in doses
ranging from 0.1 mg to 5 mg as either a single or multiple dose.
Table 3 shows systemic adverse events, reported in clinical
studies without regard to causality, from the beginning of Cetrotide®
treatment until confirmation of pregnancy by ultrasound at an incidence >
1% in Cetrotide® treated subjects undergoing COS.
|
Table 3: Adverse Events in >1% Cetrotide®
N=949
|
|
(WHO preferred term)
|
% (n)
|
|
Ovarian Hyperstimulation Syndrome#
|
3.5 (33)
|
|
Nausea
|
1.3 (12)
|
|
Headache
|
1.1 (10)
|
|
# Intensity moderate or severe, or WHO Grade
II or III, respectively
|
Local site reactions (e.g. redness, erythema, bruising, itching,
swelling, and pruritus) were reported. Usually, they were of a transient nature,
mild intensity and short duration. During post-marketing surveillance, rare
cases of hypersensitivity reactions including anaphylactoid reactions have been
reported.
Two stillbirths were reported in Phase 3 studies of Cetrotide®.
Congenital Anomalies
Clinical follow-up studies of 316 newborns of women administered
Cetrotide® were reviewed. One infant of a set of twin neonates
was found to have anencephaly at birth and died after four days. The other twin
was normal. Developmental findings from ongoing baby follow-up included a child
with a ventricular septal defect and another child with bilateral congenital
glaucoma.
Four pregnancies that resulted in therapeutic abortion in Phase
2 and Phase 3 controlled ovarian stimulation studies had major anomalies (diaphragmatic
hernia, trisomy 21, Klinefelter syndrome, polymalformation, and trisomy 18).
In three of these four cases, intracytoplasmic sperm injection (ICSI) was the
fertilization method employed; in the fourth case, in vitro fertilization
(IVF) was the method employed.
The minor congenital anomalies reported include: supernumerary
nipple, bilateral strabismus, imperforate hymen, congenital nevi, hemangiomata,
and QT syndrome. The causal relationship between the reported anomalies and
Cetrotide® is unknown. Multiple factors, genetic and others (including,
but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution
difficult to study.
DRUG INTERACTIONS
No formal drug interaction studies have been performed with
Cetrotide®.
top
