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
Pergonal Side Effects, and Drug Interactions - Menotropins
Pergonal Side Effects, and Drug Interactions - Menotropins
SIDE EFFECTS
The following adverse reactions, reported during menotropins
therapy, are listed in decreasing order
of potential severity:
1. Pulmonary and vascular
complications (see WARNINGS)
2. Ovarian Hyperstimulation Syndrome (see WARNINGS)
3. Hemoperitoneum
4. Adnexal torsion
(as a complication
of ovarian enlargement)
5. Mild to moderate ovarian
enlargement
6. Ovarian cysts
7. Abdominal pain
8. Sensitivity to menotropins
(Febrile reactions suggestive
of allergic response have been reported following the administration
of menotropins. Reports of flu-like symptoms including fever,
chills, musculoskeletal
aches, joint pains, nausea,
headaches, and malaise
have also been reported).
9. Gastrointestinal symptoms (nausea, vomiting,
diarrhea, abdominal
cramps, bloating)
10. Pain, rash, swelling
and/or irritation
at the site of injection
11. Body rashes
12. Dizziness, tachycardia,
dyspnea, tachypnea
The following medical
events have been reported subsequent to pregnancies resulting from
menotropins therapy:
1. Ectopic pregnancy
2. Congenital abnormalities
With menotropin therapy
congenital abnormalities
have been reported. One infant
was shown to have multiple
congenital anomalies
consisting of aplasia of the sigmoid
colon, cecovesicle fistula, bifid
scrotum, meningocele, bilateral internal
tibial torsion, and
right metatarsus
adductus. Other reported anomalies include imperforate
anus, congenital
heart lesions, supernumerary
digits, hypospadias, extrophy of the bladder,
Down’s syndrome and hydrocephalus. The incidence
of congenital abnormalities
does not exceed that found in the general population.
There have been infrequent reports of ovarian
neoplasms, both benign and malignant,
in women who have undergone multiple
drug regimens for ovulation
induction; however, a causal relationship has not been established.
Adverse events occurring in ³1%
of patients exposed to Repronex® IM or Repronex® SC are
described in Table 4.
Table 4: Patients with Adverse Events ³1%
|
|
Repronex IM
(N= 101)
|
Repronex SC
(N= 96)
|
|
Adverse Events
|
n (%)
|
n (%)
|
|
INJECTION SITE
|
|
Injection Site Edema
|
1 (1.0)
|
8 (8.3)*
|
|
Injection Site Reaction
|
2 (2.0)
|
8 (8.3)*
|
|
GENITOURINARY/ REPRODUCTIVE
|
|
OHSS
|
1 (1.0)
|
3 (3.0)
|
|
Vaginal Hemorrhage
|
8 (7.9)
|
3 (3.1)
|
|
Ovarian Disease
|
3 (3.0)
|
8 (8.3)
|
|
Ectopic Pregnancy
|
1 (1.0)
|
1 (1.0)
|
|
Pelvic Pain
|
3 (3.0)
|
1 (1.0)
|
|
Breast Tenderness
|
1 (2.0)
|
2 (2.1)
|
|
GASTROINTESTINAL
|
|
Nausea
|
4 (4.0)
|
7 (7.3)
|
|
Vomiting
|
0 (0)
|
3 (3.1)
|
|
Diarrhea
|
0
|
2 (2.1)
|
|
Abdominal Cramping
|
7 (6.9)
|
5 (5.2)
|
|
Abdominal Pain
|
5 (5.0)
|
7 (7.3)
|
|
Enlarged Abdomen
|
6 (6.0)
|
2 (2.1)
|
|
OTHER BODY SYSTEM
|
|
Headache
|
6 (6.0)
|
5 (5.2)
|
|
Infection
|
1 (1.0)
|
0
|
|
Dyspnea
|
1 (1.0)
|
2 (2.1)
|
- * Fisher’s Exact/Chi-Squared Tests-significant
for Repronex SC vs Repronex IM.
DRUG ABUSE AND DEPENDENCE
There have been no reports
of abuse or dependence
with menotropins.
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