Cervidil Storage and Effectiveness After Refrigeration Lapse
Do not use Cervidil (dinoprostone) if it has been left out of refrigeration, as the FDA labeling explicitly requires continuous refrigeration at 36-46°F (2-8°C) for product stability, and there is no established grace period for room temperature exposure. 1
Storage Requirements
- Cervidil must be stored under continuous refrigeration at 36-46°F (2-8°C) according to FDA labeling requirements 1
- The product label provides no allowance or guidance for any period of room temperature storage 1
- Once removed from proper refrigeration, the product's stability and effectiveness cannot be guaranteed 1
Clinical Implications
The lack of room temperature stability data means you cannot determine whether the medication remains effective after refrigeration lapse. The dinoprostone in the vaginal insert is a temperature-sensitive prostaglandin formulation designed for controlled release over 12-24 hours 2, 3. Heat exposure could potentially:
- Alter the drug's chemical stability
- Compromise the controlled-release mechanism
- Result in unpredictable drug delivery rates
- Lead to either subtherapeutic dosing (treatment failure) or excessive release (increased risk of uterine hyperstimulation)
Safety Considerations
Using compromised Cervidil poses risks to both maternal and fetal outcomes:
- Uterine hyperstimulation occurs in 5-15% of patients even with properly stored product 3
- Tachysystole with or without fetal heart rate changes occurs in approximately 9.3% of cases 4
- Compromised product could theoretically increase these complication rates or reduce efficacy 2, 3
Recommendation
Discard any Cervidil that has been left out of refrigeration and obtain a new, properly stored unit. The potential risks of using compromised medication—including treatment failure requiring repeat induction or unexpected complications from altered drug release—outweigh the cost of replacement 1, 2.