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warnings
WARNINGS For hospital use only Dinoprostone Vaginal Insert should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of postpartum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction (See ADVERSE REACTIONS, Post-marketing surveillance ). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum period. The Clinician should be alert that use of dinoprostone may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism).
ADVERSE REACTIONS Dinoprostone Vaginal Insert is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported. Table 1 Total Dinoprostone Vaginal Insert – Treated Related Adverse Events Controlled Studies Controlled Studies (with and without retrieval system) Active Placebo Uterine hyperstimulation with fetal distress 2.8% 0.3% Uterine hyperstimulation without fetal distress 4.7% 0% Fetal Distress without uterine hyperstimulation 3.8% 1.2% N 320 338 STUDY 101-801 Controlled Study (with retrieval system) Active Placebo Uterine hyperstimulation with fetal distress 2.9% 0% Uterine hyperstimulation without fetal distress 2.0% 0% Fetal Distress without uterine hyperstimulation 2.9% 1.0% N 102 104 Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Dinoprostone Vaginal Insert. In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases. In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae. Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Dinoprostone Vaginal Insert. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Dinoprostone Vaginal Insert, there were no deleterious effects on physical examination or psychomotor evaluation (18). Post-marketing surveillance Immune System Disorders: Hypersensitivity Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See Warnings Section) Reproductive system: Reports of uterine rupture have been reported in association with use of Dinoprostone Vaginal Insert some required a hysterectomy and some resulted in subsequent fetal or neonatal death. Vascular Disorders: Hypotension Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism