Prostaglandin Analog

Cervidil

Approved 30 Mar 1995VaginalInsert, extended release

Indications

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. ( 1 )

Contraindications

CERVIDIL is contraindicated in patients with: Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2) ] 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 [see Warnings and Precautions (5.4) and Drug Interactions (7) ] Six or more previous term pregnancies CERVIDIL is contraindicated for: Known hypersensitivity to prostaglandins ( 4 ) Evidence or clinical suspicion of fetal distress, where delivery is not imminent ( 4 ) Unexplained vaginal bleeding in the current pregnancy ( 4 ) Evidence or clinical suspicion of marked cephalopelvic disproportion ( 4 ) Contraindication to induction of labor ( 4 ) Concurrent use with intravenous oxytocic agents ( 4 ) History of previous cesarean section or other uterine surgery (such as myomectomy) ( 4 ) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety.

( 4 ) Six or more previous term pregnancies ( 4 )

Warnings and precautions

Disseminated Intravascular Coagulation : Assess for evolving fibrinolysis in the immediate post-partum period. ( 5.2 ) Amniotic Fluid Embolism Syndrome : Carefully monitor patients for clinical signs of hypotension, hypoxemia and respiratory failure, DIC, coma or seizures. Provide supportive care. ( 5.3 ) Uterine Tachysystole and Uterine Hypersystole/Hypertonicity : Monitor uterine activity; remove vaginal insert. ( 5.4 ) History of Glaucoma : Consider non-prostaglandin cervical ripening procedures.

Indications

Contraindications

( 4 ) Six or more previous term pregnancies ( 4 )

Warnings and precautions

Adverse reactions

The following adverse reactions are described, or described in greater detail, in other sections: Disseminated Intravascular Coagulation [see Warnings and Precautions (5.2) ] Amniotic Fluid Embolism [see Warnings and Precautions (5.3) ] Uterine Tachysytole and Uterine Hypersystole/Hypertonicity [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 2 %) are uterine tachysystole without fetal distress, uterine tachysystole with fetal distress, and fetal distress without uterine tachysystole.

( 6.1 ) 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.

6.1Clinical 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 [see Clinical Studies (14) ].

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.

6.2Postmarketing 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

Cervidil

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Cervidil

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1For Hospital Use Only

5.2Disseminated Intravascular Coagulation

5.3Amniotic Fluid Embolism Syndrome

5.4Uterine Tachysystole and Uterine Hypersystole/Hypertonicity

5.5Glaucoma

Interactions

7.1Oxytocic Agents

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information

At a glance