Cervidil Drug Information
Generic name: DINOPROSTONE
Prostaglandin Analog [EPC]
Uses of Cervidil
is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is a prostaglandin analog indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
Dosage & Administration of Cervidil
Side Effects of Cervidil
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In placebo-controlled trials of 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women), the following treatment related adverse reactions (see Table 1 ) occurred at an incidence greater than 2% (and greater than that reported in the placebo group) in the CERVIDIL group. Table 1. Common Adverse Reactions (≥ 2%) in Pregnant Patients Near Term Gestation in Trial 1 Trial 1 (101-103) and Trial 2 (101-003) evaluated the dinoprostone insert only, without the use of a retrieval system, Trial 2, and Trial 3 Trial 3 (101-801) evaluated the dinoprostone insert with the retrieval system.
Trials 1 and 2 CERVIDIL (N=320) Placebo (N=338) Uterine tachysystole with fetal distress 2.8% 0.3% Uterine tachysystole without fetal distress 4.7% 0% Fetal distress without uterine tachysystole - 3.8% 1.2% Trial 3 CERVIDIL (N=102) Placebo (N=104) Uterine tachysystole with fetal distress 2.9% 0% Uterine tachysystole -without fetal distress 2% 0% Fetal distress without uterine tachysystole 2.9% 1% Drug related fever, nausea, vomiting, diarrhea, and abdominal pain occurred in less than 1% of CERVIDIL-treated patients. In Trial 3 (with the retrieval system) cases of tachysystole uterine hyperstimulation reversed within 2 to 13 minutes of removal of CERVIDIL. Tocolytics were required in one of the five cases.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of CERVIDIL or other dinoprostone products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Disseminated Intravascular Coagulation Cardiovascular disorders: Myocardial Infarction in women with a history of myocardial infarction Immune system disorders: Hypersensitivity Nervous system disorders: Headache Pregnancy, puerperium and perinatal conditions: Amniotic fluid embolism Reproductive system: reports of uterine rupture have been reported in association with use of CERVIDIL. Some required a hysterectomy and others resulted in subsequent fetal or neonatal death.
Uterine hypertonus Vascular disorders: Hypotension
Warnings & Cautions for Cervidil
For Hospital Use Only
CERVIDIL should be administered in a hospital setting with an obstetrical care facility.
Disseminated Intravascular Coagulation
CERVIDIL should be used with caution in women at high risk of postpartum disseminated intravascular coagulation (DIC). Physiologic or pharmacologic induction of labor, including the use of CERVIDIL, is associated with an increased risk of DIC during the postpartum period. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have an increased risk of DIC during the postpartum period. As soon as possible, assess for an evolving fibrinolysis in the immediate post-partum period.
Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly.
Amniotic Fluid Embolism Syndrome
The use of dinoprostone-containing products, including CERVIDIL, can result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of Amniotic Fluid Embolism Syndrome, a rare and often fatal obstetric condition. Carefully monitor patients for clinical signs of Amniotic Fluid Embolism Syndrome including hypotension, hypoxemia and respiratory failure, DIC, coma or seizures and provide supportive care as needed.
Uterine Tachysystole and Uterine Hypersystole/Hypertonicity
The use of CERVIDIL may cause uterine tachysystole with or without fetal heart rate changes (see Table 1 ). While using CERVIDIL, carefully monitor uterine activity, fetal status and the progression of cervical dilatation and effacement. Remove CERVIDIL with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences. CERVIDIL is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of the risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and the occurrence of fetal or neonatal death). Prostaglandins, including CERVIDIL, may potentiate the effect of oxytocin . Remove CERVIDIL at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity.
Remove CERVIDIL prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone.
Glaucoma Prostaglandins, including
CERVIDIL, can lead to raised intraocular pressure and constriction of pupils. Consider non-prostaglandin cervical ripening procedures in patients with Glaucoma.
Drug Interactions with Cervidil
Oxytocic Agents
CERVIDIL is contraindicated in patients receiving intravenous oxytocic agents because CERVIDIL may augment the activity of oxytocic agents. A dosing interval of at least 30 minutes is recommended for the sequential use of an oxytocic agent following the removal of CERVIDIL.
Pregnancy Safety for Cervidil
Pregnancy Risk Summary CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. Fetal, neonatal, and maternal risks are discussed throughout the labeling. Limited available data with CERVIDIL use in pregnant women do not show a clear association with adverse developmental outcomes.
Relevant animal reproduction data with dinoprostone is not available. Data Human Data In a report of a 3-year pediatric follow-up study, there were no deleterious effects noted on physical examination or psychomotor evaluation of 51 infants born following maternal treatment with CERVIDIL. Clinical Considerations Fetal/Neonatal Adverse Reactions When CERVIDIL was removed for fetal distress, there was a return to normal rhythm and there were no neonatal sequelae. Remove CERVIDIL in the event of persistent tachysystole with or without fetal heart rate changes, and follow established institutional protocols in management of patients.
Pediatric Use of Cervidil
Pediatric Use The safety and effectiveness of CERVIDIL have not been established in pregnant girls.
Contraindications for Cervidil
is contraindicated in patients with: Known hypersensitivity to prostaglandins Evidence or clinical suspicion of fetal distress where delivery is not imminent Unexplained vaginal bleeding in the current pregnancy Evidence or clinical suspicion of marked cephalopelvic disproportion Conditions for which induction of labor is contraindicated Conditions for which oxytocic drugs are contraindicated Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety Concurrent use with intravenous oxytocic agents Six or more previous term pregnancies CERVIDIL is contraindicated for: Known hypersensitivity to prostaglandins Evidence or clinical suspicion of fetal distress, where delivery is not imminent Unexplained vaginal bleeding in the current pregnancy Evidence or clinical suspicion of marked cephalopelvic disproportion Contraindication to induction of labor Concurrent use with intravenous oxytocic agents History of previous cesarean section or other uterine surgery (such as myomectomy) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety. Six or more previous term pregnancies
Clinical Studies of Cervidil
The effectiveness and safety of CERVIDIL for the induction of cervical ripening was evaluated in 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women) at or near term in three randomized, double-blind, placebo-controlled trials (Trials 1, 2, and 3). Efficacy outcomes included percentage with treatment success (defined as vaginal delivery within 12 hours, Bishop Score ≥ 6 in the 12-hour observation period, or ≥ 3 increase in the Bishop score in the 12-hour observation period), time to delivery, and time to onset of labor. Table 2 presents efficacy outcomes from Trials 1, 2, and 3. Table 2: Efficacy Outcomes in Pregnant Women in Trials 1 Trial 1 and Trial 2 evaluated the dinoprostone insert only, without the use of a retrieval system., 2, and 3 Trial 3 evaluated the dinoprostone insert with the retrieval system for CERVIDIL Ripening, Intent-to-Treat Population Primipara/Nullipara Multipara Study # CERVIDIL Placebo CERVIDIL Placebo P-Value Treatment Success Treatment success was defined as vaginal delivery within 12 hours, Bishop score ≥ 6 in the 12-hour observation period, or ≥ 3 increase in the Bishop score in the 12-hour observation period. Trial 1 (N=81) 65% (n=26) 28% (n=32) 87% (n=16) 29% (n=7) <0.001 Trial 2 (N=371) 68% (n=111) 24% (n=123) 77% (n=65) 24% (n=72) <0.001 Trial 3 (N=206) 72% (n=60) 48% (n=63) 55% (n=42) 41% (n=41) 0.003 Median Time to Delivery (hours) Trial 1 (N=81) 25.7 (n=26) 34.5 (n=32) 12.3 (n=16) 24.6 (n=7) 0.001 Trial 3 (N=206) 25.5 (n=60) 37.2 (n=63) 20.8 (n=42) 27.4 (n=41) <0.001 Median Time to Onset of Labor (hours) Trial 1 (N=81) 12 (n=26) 19.2 (n=32) 6.9 (n=16) 18.3 (n=7) <0.001
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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