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Intended for U.S. Healthcare Professionals

Expecting Moms

Proven to Work

In clinical trials, CERVIDIL provided successful ripening over a 12-hour period1

CERVIDIL vaginal insert (dinoprostone, 10 mg) is proven to work

Proven to Work

In clinical trials, CERVIDIL provided successful ripening over a 12-hour period1

A single dose of FDA-approved CERVIDIL successfully ripened the cervix in the majority of patients in clinical trials*

CERVIDIL vaginal insert (dinoprostone, 10 mg) is clinically proven CERVIDIL vaginal insert (dinoprostone, 10 mg) is clinically proven

Study design: CERVIDIL was studied in 3 randomized, double-blind, placebo-controlled clinical trials in which 658 women were entered and 320 received active therapy. Studies 101-003 (N=371) and 101-103 (N=81) involved the vaginal pessary alone, whereas study 101-801 (N=206) used the vaginal pessary inserted into a knitted polyester retrieval system.

*Treatment success was defined as Bishop score increase at 12 hours of ≥3, vaginal delivery within 12 hours, or Bishop score at 12 hours of ≥6.

An Effective Way to Ripen1

Treatment success of CERVIDIL vaginal insert (dinoprostone, 10 mg) Treatment success of CERVIDIL vaginal insert (dinoprostone, 10 mg)
Cervidil Ripen Chart Legend

In clinical trials, a single dose of CERVIDIL successfully ripened the cervix in the majority of patients.

†Treatment success was defined as Bishop score increase at 12 hours of ≥3, vaginal delivery within 12 hours, or Bishop score at 12 hours of ≥6. These studies were not designed with the power to show differences in cesarean section rates between CERVIDIL and placebo groups and none were noted.

Shorter Median Time To Delivery1

Median time to delivery with CERVIDIL vaginal insert (dinoprostone, 10 mg) Median time to delivery with CERVIDIL vaginal insert (dinoprostone, 10 mg)

Studies demonstrated that CERVIDIL significantly reduced median time to delivery

  • In study 101-103 median time to delivery was 26% shorter for nulliparous and primiparous women and 50% shorter for multiparous women on CERVIDIL vs placebo
  • In study 101-801 median time to delivery was 31% shorter for nulliparous and primiparous women and 24% shorter for multiparous women on CERVIDIL vs placebo
Cervidil Delivery Chart Legend

Reduced Median Time
to Onset of Labor1

Median time to onset of labor with CERVIDIL vaginal insert (dinoprostone, 10 mg) Median time to onset of labor with CERVIDIL vaginal insert (dinoprostone, 10 mg)

Studies showed that CERVIDIL significantly reduced median time to onset of labor

  • Median time to onset of labor of 12 hours was observed in primiparous and nulliparous women
  • Multiparous women demonstrated reduced median time to onset of labor of 6.9 hours
Cervidil Labor Chart Legend

See CERVIDIL in action in the administration video

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CERVIDIL 7 Challenge

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What type of prostaglandin is CERVIDIL?

Important Safety Information
Important Safety Information
INDICATION

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.

CERVIDIL is 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.

Upon removal of CERVIDIL, it is essential to ensure that the slab has been removed as it may have separated from the knitted polyester retrieval system and will continue delivering the active ingredient.

IMPORTANT SAFETY INFORMATION

Contraindications

CERVIDIL is contraindicated in:

  • Patients with known hypersensitivity to prostaglandins
  • Patients in whom there is a clinical suspicion or definitive 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 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)
  • Patients already receiving intravenous oxytocic drugs
  • Multipara with 6 or more previous term pregnancies
Warnings and Precautions
  • CERVIDIL is for hospital use only and should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.
  • 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).
  • Prostaglandins, including CERVIDIL, may augment the activity of oxytocic agents and their concomitant use is not recommended. CERVIDIL must be removed before oxytocin administration is initiated and a dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin.
  • Uterine activity, fetal status, and the progression of cervical dilatation and effacement should be carefully monitored whenever the CERVIDIL 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. CERVIDIL should also be removed prior to amniotomy.
  • 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.
  • Long-term carcinogenicity and fertility studies have not been conducted with CERVIDIL. No evidence of mutagenicity has been observed with prostaglandin E2 in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay.
  • Pregnancy Category C: 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 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.
  • 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.
  • 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. 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 postpartum period. An increased risk of postpartum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin.
Adverse Reactions
  • In clinical trials, the most commonly occurring adverse reactions were uterine hyperstimulation with fetal distress (2.8% vs 0.3% for placebo), uterine hyperstimulation without fetal distress (4.7% vs 0%), and fetal distress without uterine hyperstimulation (3.8% vs 1.2%).
  • Drug-related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received CERVIDIL.

Important Safety Information      Prescribing Information