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Intended for U.S. Healthcare Professionals

Expecting Moms
CERVIDIL vaginal insert (dinoprostone, 10 mg) is your key to cervical ripening

your key to
cervical ripening

Keep control at your fingertips with easy insertion and removal of CERVIDIL1

See How To Properly Administer

Proper Administration of CERVIDIL will help optimize drug delivery1

inserting CERVIDIL
Prepare

Pick up the insert between 2 fingers and lightly coat with water-miscible lubricant.

CERVIDIL is placed at vaginal fornix
Insert

Gently place your fingers with the insert into the vagina. Position the insert transversely in the posterior vaginal fornix. Take care not to dislodge the insert when removing fingers. Slightly tuck the retrieval tape into the vagina.

Removing CERVIDIL
Retrieve

To retrieve, locate the retrieval tape and pull it gently until the product is fully removed.

Upon removal of CERVIDIL, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient.

Important
Guidelines

  • CERVIDIL must be kept frozen until use and is stable when stored in a freezer for a period of 3 years
  • There is no need for previous warming of the product
  • Insert immediately after removal from its foil package
  • CERVIDIL does not require sterile conditions
  • CERVIDIL must not be used without its retrieval system
  • Do not wrap the retrieval tape around the insert before insertion
  • Do not overlubricate; excess lubricant 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
Single-dose CERVIDIL

Just One Dose

A single dose to help ripen the cervix1

  • Controlled-release drug delivery – Formulated to release 0.3 mg/hr for up to 12 hours
  • Releases drug at the cervix
  • Up to 12 hours of drug delivery without multiple administrations

Removed In Seconds
Cleared In Minutes

Maintain control and
retrieve with ease1

  • Long tape facilitates immediate removal
  • The half-life of dinoprostone is 2.5 to 5 minutes

When to remove CERVIDIL

  • 12 hours after insertion or upon onset of active labor, or whichever comes first
  • Prior to amniotomy
  • With any evidence of uterine hyperstimulation, sustained uterine contractions, fetal distress, and other fetal or maternal adverse reactions
  • Before oxytocin administration is initiated; the patient’s uterine activity should be carefully monitored for uterine hyperstimulation
CERVIDIL vaginal insert (dinoprostone, 10 mg) retrieval system
CERVIDIL 7 Challenge

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When administering CERVIDIL, it is inappropriate to wrap the long retrieval tape around the insert.

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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