Data from FDA - Curated by EPG Health - Last updated 22 December 2016

Indication(s)

INDICATIONS AND USAGE Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

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Advisory information

contraindications
CONTRAINDICATIONS Cervidil is contraindicated in: Patients with known hypersensitivity to prostaglandins. Patients in whom there is clinical suspicion or definite evidence of fetal distress where delivery is not imminent. Patients with unexplained vaginal bleeding during this pregnancy. Patients in whom there is evidence or strong suspicion of marked cephalopelvic disproportion. Patients in whom oxytocic drugs are contraindicated or when prolonged contraction of the uterus may be detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery (see PRECAUTIONS and ADVERSE REACTIONS ). Patients already receiving intravenous oxytocic drugs. Multipara with 6 or more previous term pregnancies.
Special warnings and precautions
PRECAUTIONS 1. General Precautions Since prostaglandins potentiate the effect of oxytocin, Cervidil must be removed before oxytocin administration is initiated and the patient's uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil should also be removed prior to amniotomy. Cervidil is contraindicated when prolonged contraction of the uterus may be detrimental to fetal safety and uterine integrity. Therefore, Cervidil should not be administered to patients with a history of previous cesarean section or uterine surgery given the potential risk for uterine rupture and associated obstetrical complications, including the need for hysterectomy and the occurrence of fetal or neonatal death. Caution should be exercised in the administration of Cervidil for cervical ripening in patients with ruptured membranes, in cases of non-vertex or non-singleton presentation, and in patients with a history of previous uterine hypertony, glaucoma, or a history of childhood asthma, even though there have been no asthma attacks in adulthood. Uterine activity, fetal status and the progression of cervical dilatation and effacement should be carefully monitored whenever the dinoprostone vaginal insert is in place. With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, or other fetal or maternal adverse reactions, the vaginal insert should be removed. An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin. 2. Drug Interactions Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified. 3. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity and fertility studies have not been conducted with Cervidil (dinoprostone) Vaginal Insert. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay. 4. Pregnancy Teratogenic Effects Prostaglandin E2 has produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since Cervidil (dinoprostone) Vaginal Insert is administered after the period of organogenesis. Prostaglandin E2 has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. 5. Pediatric Use The safety and efficacy of Cervidil has been established in women of a reproductive age and women who are pregnant. Although safety and efficacy has not been established in pediatric patients, safety and efficacy are expected to be the same for adolescents.
Adverse reactions
ADVERSE REACTIONS Cervidil 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 Cervidil – Treated Drug-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 Cervidil. 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 Cervidil. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil, 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 Cervidil some required a hysterectomy and some resulted in subsequent fetal or neonatal death. Vascular Disorders: Hypotension Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism To report SUSPECTED ADVERSE REACTIONS, contact FERRING PHARMACEUTICALS INC. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12 hour period. Cervidil should be removed upon onset of active labor or 12 hours after insertion. Cervidil is supplied in an individually wrapped aluminium/polyethylene package with a "tear mark" on one side of the package. The package should only be opened by tearing the aluminium package along the tear mark. The package should never be opened with scissors or other sharp objects which may compromise or cut the knitted polyester pouch that serves as the retrieval system for the polymeric slab. Cervidil must be kept frozen until use, and is administered by placing one unit transversely in the posterior fornix of the vagina immediately after removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of water-miscible lubricant may be used to assist insertion of Cervidil. Care should be taken not to permit excess contact or coating with the lubricant which could prevent optimal swelling and release of dinoprostone from the vaginal insert. Patients should remain in the recumbent position for 2 hours following insertion, but thereafter may be ambulatory. If the patient is ambulatory, care should be taken to ensure the vaginal insert remains in place. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Cervidil should also be removed prior to amniotomy. Upon removal of Cervidil, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. This is accomplished by visualizing the knitted polyester retrieval system and confirming that it contains the slab. In the rare instance that the slab is not contained within the polyester retrieval system, a vaginal exam should be performed to remove the slab.

Interactions

2. Drug Interactions Cervidil may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified.

More information

Category Value
Authorisation number NDA020411
Agency product number K7Q1JQR04M
Orphan designation No
Product NDC 55566-2800
Date Last Revised 22-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 597959
Storage and handling Store in a freezer between -20°C and -10°C (-4°F and 14°F). Cervidil is packed in foil and is stable when stored in a freezer for a period of three years. Vaginal inserts exposed to high humidity will absorb moisture from the air and thereby alter the release characteristics of dinoprostone. Once used, the vaginal insert should be discarded.
Marketing authorisation holder Ferring Pharmaceuticals Inc.