CERVIDIL
Generic: DINOPROSTONE
Basic Information
Manufacturer
Ferring Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
f3bc9031-0620-4a50-b440-f661cadfeb1d
Indications & Usage
1 INDICATIONS AND USAGE 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 )
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 )
Adverse Reactions
6 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.
6.1 Clinical 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.
6.2 Postmarketing 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
( 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.
6.1 Clinical 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.
6.2 Postmarketing 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