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Assisted Reproductive Technologies (ART)
Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim®in 989 infertile women treated with in vitro fertilization with Follistim®or urofollitropin after pituitary suppression with a GnRH agonist are summarized in Table 5.
Table 5. Incidence of Adverse Clinical Experiences ( > 1%)
|Adverse Event||Follistim® (n=591)|
|Ovarian Hyperstimulation Syndrome||5.2%|
|Injection site pain||1.7%|
Rates of adverse events from a randomized, assessor-blind, group comparative, multi-center safety and efficacy study of Follistim® in 172 chronic anovulatory women who failed to ovulate and/or conceive during clomiphene citrate treatment are summarized in Table 6.
Table 6. Incidence of Adverse Clinical Experiences ( > 1%)
|Adverse Event||Follistim® (n=105)|
|Ovarian Hyperstimulation Syndrome||7.6%|
|Abdominal pain, lower||2.9%|
The following adverse events have been reported in women treated with gonado tropins: 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, mus culoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms (dry skin, erythema, body rash, hair loss, and hives)
There have been infrequent reports of ovarian neoplasms, both benign and malig nant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations.
Drug Abuse And Dependence
There have been no reports of abuse or dependence with Follistim® AQ (follitropin beta) (follitropin beta injection).
Read the Follistim AQ (follitropin beta) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been performed.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/17/2008
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