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
Antagon Side Effects, and Drug Interactions - Ganirelix
Antagon Side Effects, and Drug Interactions - Ganirelix
SIDE EFFECTS
The safety of Antagon™ (ganirelix acetate) Injection was evaluated in two randomized,
parallel-group, multicenter controlled clinical studies. Treatment duration
for Antagon™ ranged from 1 to 14 days. Table IV represents adverse events (AEs)
from first day of Antagon™ administration until confirmation of pregnancy by
ultrasound at an incidence of ≥ 1% of Antagon™-treated subjects without
regard to causality.
TABLE IV: Incidence of common adverse events
(Incidence ≥1% in Antagon™-treated subjects). Completed controlled
clinical studies (All-subjects-treated group).
|
Adverse Events Occurring in ≥ 1%
|
Antagon™ N=794
% (n) |
|
Abdominal Pain (gynecological)
|
4.8 (38) |
|
Death Fetal
|
3.7 (29) |
|
Headache
|
3.0 (24) |
|
Ovarian Hyperstimulation Syndrome
|
2.4 (19) |
|
Vaginal Bleeding
|
1.8 (14) |
|
Injection Site Reaction
|
1.1 (9) |
|
Nausea
|
1.1 (9) |
|
Abdominal Pain (gastrointestinal)
|
1.0 (8) |
Congenital Anomalies
Ongoing clinical follow-up studies of 283 newborns of women administered Antagon™
were reviewed. There were three neonates with major congenital anomalies and
18 neonates with minor congenital anomalies. The major congenital anomalies
were: hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome.
The minor congenital anomalies were: nevus, skin tags, sacral sinus, hemangioma,
torticollis/asymmetric skull, talipes, supernumerary digit finger, hip subluxation,
torticollis/high palate, occiput/abnormal hand crease, hernia umbilicalis, hernia
inguinalis, hydrocele, undescended testis, and hydronephrosis. The causal relationship
between these congenital anomalies and Antagon™ is unknown. Multiple factors,
genetic and others (including, but not limited to ICSI, IVF, gonadotropins,
progesterone) may confound ART (Assisted Reproductive Technology) procedures.
DRUG INTERACTIONS
No formal drug-drug interaction studies have been performed.
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