FAQs What is CERVIDIL?

Each CERVIDIL vaginal insert contains medicine called dinoprostone (also known as a prostaglandin), which is similar to a natural hormone produced by your body. CERVIDIL helps your cervix gradually relax and dilate (open) so the baby can pass through the birth canal.

Why do I need CERVIDIL?

Your Doctor or Midwife may decide it’s time to use CERVIDIL because you are at, or past, your due date; your water breaks but your body hasn’t started labor yet; or there is medical need for your baby to be delivered.1

Does CERVIDIL cause contractions?

CERVIDIL is used for preparing the cervix for labor and may start mild contractions during the cervical ripening process. Some patients may require Pitocin® or (oxytocin) to either start or strengthen contractions no earlier than 30 minutes after CERVIDIL is removed.

Why can’t my cervix get ready on its own?

1 in 4 women are induced. Sometimes you need more dinoprostone, similar to a natural hormone produced by your body to get ready for labor.You and your Doctor or Midwife can discuss if CERVIDIL is needed.

Why does my cervix need to get ready for labor?

Your cervix needs to soften, thin, and dilate in order for your baby to be delivered. CERVIDIL is the only FDA-approved vaginal insert that can help get your cervix ready for labor.1,2

How does CERVIDIL work?

Each CERVIDIL vaginal insert contains medicine called dinoprostone, which is similar to a natural prostaglandin found in your body. Dinoprostone signals your body to begin the process that helps your cervix gradually soften, thin, and dilate (open) as it would have done naturally.

Is CERVIDIL the same as Pitocin® (oxytocin)?

No, CERVIDIL is used to help get your cervix ready for labor, which is needed before starting contractions. Pitocin® (oxytocin) is used to generate or strengthen existing contractions.

Why is it important that CERVIDIL is FDA approved?

All drugs must be proven safe and effective to FDA’s standards before companies can market them. If the FDA grants approval to a drug, it means they have determined that the benefits of the product outweigh the risks for the intended use.

What if I don’t want an induction?

It is important to discuss the possibility of an induction with your Doctor or Midwife before your due date. There may be medical reasons that make an induction necessary.  Knowing more can help ease any concerns you may have.

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Please see important safety information and full prescribing information.

INDICATION

CERVIDIL® (dinoprostone, 10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor.

For the first two (2) hours following insertion, you should remain lying down. If you sit up or walk after the first two hours, you should be careful to ensure the insert remains in place. While CERVIDIL is inserted, your doctor will carefully monitor your progress and your baby’s well-being and will determine when the insert should be removed.

IMPORTANT SAFETY INFORMATION ABOUT CERVIDIL

CERVIDIL should only be inserted by a trained healthcare professional in a hospital setting appropriate for childbirth.

Who should NOT be given CERVIDIL?

You should NOT be given CERVIDIL if you have:

  • Experienced an allergic reaction to prostaglandins (certain hormone-like substances)
  • Experienced unexplained vaginal bleeding during your pregnancy
  • Already started receiving drugs to induce labor
  • Given birth six or more times in your lifetime

You should also NOT be given CERVIDIL if your doctor has determined that:

  • Your baby is in distress and needs to be delivered urgently
  • Your baby may be too large to fit through your birth canal (“cephalopelvic disproportion”)
  • Drugs used to induce labor are not appropriate for you or that prolonged contraction of your uterus may be harmful to you or your baby such as if you have had a previous cesarean section or major surgery on your uterus.

What are the most serious risks associated with the use of CERVIDIL?

The induction of labor has been associated with an increased risk of a disorder of abnormal clotting of the blood that results in excessive bleeding immediately after birth (“disseminated intravascular coagulation” or DIC). The risk is higher in women over age 30, those with complications during pregnancy, and those whose pregnancy has lasted longer than 40 weeks.

In rare cases, the use of CERVIDIL has been associated with an increased risk of a life-threatening event to the mother called “amniotic fluid embolism.” The cause of amniotic fluid embolism is not well understood but it is believed that some amniotic fluid or other substances can get into your bloodstream and start a severe reaction that can cause heart and lung collapse.

What should I discuss with my doctor before labor induction begins or CERVIDIL is given?

As you would throughout your pregnancy, be sure to tell your doctor about all prescription or over-the-counter medications you are taking. Before CERVIDIL is given, be sure you have told your doctor about all your current and past medical conditions, including:

  • If your water has broken
  • Any unexplained vaginal bleeding during pregnancy
  • All uterine surgeries, especially previous cesarean section
  • A history of contractions lasting more than 2 minutes
  • Glaucoma
  • Asthma, even if you had childhood asthma and have had no asthma attacks as an adult

What are the most common side effects of CERVIDIL?

The most common side effects associated with the administration of CERVIDIL are contractions occurring at a rate faster than normal (tachysystole) and signs that the baby is exhausted or in distress (uterine hyperstimulation). In clinical trials, these effects occurred alone or together in less than 1 in 20 women who were given CERVIDIL.

In clinical trials, fever, nausea, vomiting, diarrhea and abdominal pain were noted in less than 1 in 100 women who were given CERVIDIL.
This is not a complete list of possible side effects.

If you experience an adverse event please discuss it with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

People depicted in images are models. Images used for illustrative purposes.

Please see full Prescribing Information

References: 1. CERVIDIL [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.  2. FDA Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed August 17, 2015.