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DINOPROSTONE

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Overview

What is DINOPROSTONE?

Dinoprostone Vaginal Insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

The chemical name for dinoprostone (commonly known as prostaglandin E or PGE) is 11α,15S-dihydroxy-9-oxo-prosta-5Z,13E-dien-1-oic acid and the structural formula is represented below:

The molecular formula is CHO and its molecular weight is 352.5. Dinoprostone occurs as a white to off-white crystalline powder. It has a melting point within the range of 65° to 69°C. Dinoprostone is soluble in ethanol and in 25% ethanol in water. Each insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer which is a semiopaque, beige colored, flat rectangular slab measuring 29 mm by 9.5 mm and 0.8 mm in thickness. The insert and its retrieval system, made of polyester yarn, are nontoxic and when placed in a moist environment, absorb water, swell, and release dinoprostone.



What does DINOPROSTONE look like?



What are the available doses of DINOPROSTONE?

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What should I talk to my health care provider before I take DINOPROSTONE?

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How should I use DINOPROSTONE?

Dinoprostone Vaginal Insert 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.

The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12 hour period. Dinoprostone Vaginal Insert should be removed upon onset of active labor or 12 hours after insertion.

Dinoprostone Vaginal Insert is supplied in an individually wrapped aluminium/polyethylene package with a "tear mark" on one side of the package. The package should only be opened by tearing the aluminium package along the tear mark. The package should never be opened with scissors or other sharp objects which may compromise or cut the knitted polyester pouch that serves as the retrieval system for the polymeric slab.

Dinoprostone Vaginal Insert must be kept frozen until use, and is administered by placing one unit transversely in the posterior fornix of the vagina immediately after removal from its foil package. The insertion of the vaginal insert does not require sterile conditions. The vaginal insert must not be used without its retrieval system. There is no need for previous warming of the product. A minimal amount of water-miscible lubricant may be used to assist insertion of Dinoprostone Vaginal Insert. Care should be taken not to permit excess contact or coating with the lubricant which 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. If the patient is ambulatory, care should be taken to ensure the vaginal insert remains in place. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Dinoprostone Vaginal Insert should also be removed prior to amniotomy.

Upon removal of Dinoprostone Vaginal Insert, it is essential to ensure that the slab has been removed, as it will continue delivering the active ingredient. This is accomplished by visualizing the knitted polyester retrieval system and confirming that it contains the slab. In the rare instance that the slab is not contained within the polyester retrieval system, a vaginal exam should be performed to remove the slab.


What interacts with DINOPROSTONE?


  • Dinoprostone Vaginal Insert is contraindicated in:


    • Patients with known hypersensitivity to prostaglandins.
    • Patients in whom there is clinical suspicion or definite 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 major uterine surgery (see and ).
    • Patients already receiving intravenous oxytocic drugs.
    • Multipara with 6 or more previous term pregnancies.




What are the warnings of DINOPROSTONE?

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For hospital use only

Dinoprostone Vaginal Insert should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

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 (See ). Therefore, 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 post-partum period.

The Clinician should be alert that 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).


What are the precautions of DINOPROSTONE?

1. General Precautions

Since prostaglandins potentiate the effect of oxytocin, Dinoprostone Vaginal Insert must be removed before oxytocin administration is initiated and the patient's uterine activity carefully monitored for uterine hyperstimulation. If uterine hyperstimulation is encountered or if labor commences, the vaginal insert should be removed. Dinoprostone Vaginal Insert should also be removed prior to amniotomy.

Dinoprostone Vaginal Insert is contraindicated when prolonged contraction of the uterus may be detrimental to fetal safety and uterine integrity. Therefore, Dinoprostone Vaginal Insert should not be administered to patients with a history of 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.

Caution should be exercised in the administration of Dinoprostone Vaginal Insert 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.

Uterine activity, fetal status and the progression of cervical dilatation and effacement should be carefully monitored whenever the Dinoprostone 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. An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by physiologic means, either with dinoprostone or oxytocin.

2. Drug Interactions

Dinoprostone Vaginal Insert may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the Dinoprostone Vaginal Insert. No other drug interactions have been identified.

3. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity and fertility studies have not been conducted with Dinoprostone Vaginal Insert. No evidence of mutagenicity has been observed with prostaglandin E in the Unscheduled DNA Synthesis Assay, the Micronucleus Test, or Ames Assay.

4. Pregnancy

5. Pediatric Use

The safety and efficacy of Dinoprostone Vaginal Insert 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.


What are the side effects of DINOPROSTONE?

Dinoprostone Vaginal Insert is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported.

Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Dinoprostone Vaginal Insert.

In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases.

In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae.

Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Dinoprostone Vaginal Insert. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Dinoprostone Vaginal Insert, there were no deleterious effects on physical examination or psychomotor evaluation (18).

Table 1 Total Dinoprostone Vaginal Insert – Treated Related Adverse Events
ActivePlacebo
Uterine hyperstimulation with fetal distress2.8%0.3%
Uterine hyperstimulation without fetal distress4.7%0%
Fetal Distress without uterine hyperstimulation3.8%1.2%
N320338
STUDY 101-801Controlled Study (with retrieval system)
ActivePlacebo
Uterine hyperstimulation with fetal distress2.9%0%
Uterine hyperstimulation without fetal distress2.0%0%
Fetal Distress without uterine hyperstimulation2.9%1.0%
N102104


Post-marketing surveillance

Immune System Disorders: Hypersensitivity

Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See Section)

Reproductive system: Reports of uterine rupture have been reported in association with use of Dinoprostone Vaginal Insert some required a hysterectomy and some resulted in subsequent fetal or neonatal death.

Vascular Disorders: Hypotension

Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism


What should I look out for while using DINOPROSTONE?

Dinoprostone Vaginal Insert is contraindicated in:

For hospital use only

Dinoprostone Vaginal Insert should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

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 (See ). Therefore, 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 post-partum period.

The Clinician should be alert that 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).


What might happen if I take too much DINOPROSTONE?

Dinoprostone Vaginal Insert is used as a single dosage in a single application. Overdosage is usually manifested by uterine hyperstimulation which may be accompanied by fetal distress, and is usually responsive to removal of the insert. Other treatment must be symptomatic since, to date, clinical experience with prostaglandin antagonists is insufficient.

The use of beta-adrenergic agents should be considered in the event of undesirable increased uterine activity.


How should I store and handle DINOPROSTONE?

Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Dinoprostone Vaginal Insert (NDC 55566-9500-1) contains 10 mg dinoprostone. The product is wound and enclosed in an aluminium/polyethylene pack.