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
Follistim Side Effects, and Drug Interactions - Follitropin Beta
Follistim Side Effects, and Drug Interactions - Follitropin Beta
SIDE EFFECTS
Assisted Reproductive Technologies (ART)
Rates of adverse events from a randomized, assessor- blind, group
comparative, multicenter safety and efficacy study of Follistim™
(Protocol 37608) in 989 infertile women treated with in vitro
fertilization
with Follistim™ or Metrodin® after pituitary suppression
with a GnRH agonist
are summarized in Table 8.
Table 8: Incidence of Adverse Clinical Experiences
(> 11%) that Occurred In
Protocol 37608
|
Adverse Event
|
Follistim™
(n= 591)
|
Metrodin®
(n= 398)
|
| Miscarriage |
11.0%
|
11.3%
|
| Ovarian Hyperstimulation
Syndrome |
5.2%
|
4.3%
|
| Ectopic pregnancy
|
3.0%
|
3.8%
|
| Abdominal pain
|
2.5%
|
2.3%
|
| Injection site
pain |
1.7%
|
0.5%
|
| Vaginal hemorrhage
|
1.5%
|
0.8%
|
Ovulation Induction
Rates of adverse events from a randomized, assessor- blind, group
comparative, multicenter safety and efficacy study of Follistim™
(Protocol 37609) in 172 chronic
anovulatory women who failed to ovulate and/ or conceive
during clomiphene citrate
treatment are summarized
in Table 9.
Table 9: Incidence of Adverse Clinical Experiences
(> 1%) that Occurred In
Protocol 37609
|
Adverse Event
|
Follistim™
(n= 105)
|
Metrodin®
(n= 67)
|
| Miscarriage |
9.5%
|
9.0%
|
| Ovarian Hyperstimulation
Syndrome |
7.6%
|
4.5%
|
| Abdominal discomfort
|
2.9%
|
1.5%
|
| Abdominal pain, lower
|
2.9%
|
1.5%
|
| Abdominal pain
|
1.9%
|
3.0%
|
| Ovarian cyst
|
2.9%
|
3.0%
|
The following adverse events have been reported in women treated
with gonadotropins: pulmonary and vascular
complications (see WARNINGS),
hemoperitoneum, adnexal
torsion, (as a complication
of ovarian enlargement),
dizziness, tachycardia, dyspnea, tachypnea, febrile
reactions, flu-like symptoms including fever, chills, musculoskeletal
aches, joint pains, nausea,
headache and malaise, breast
tenderness, and dermatological symptoms (dry skin, body rash, hair
loss and hives).
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.
DRUG ABUSE AND DEPENDENCE
There have been no reports of abuse
or dependence with
Follistim™ (follitropin beta for injection).
DRUG INTERACTIONS
No drug/drug interaction studies have been performed.
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