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RevAssist: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide
Carmen P Castaneda1, Jerome B Zeldis, John Freeman
1Global Drug Safety, Celgene Corporation, Summit, New Jersey 07901, USA.
Drug Safety
|August 19, 2008
Summary
The RevAssist program effectively prevents fetal exposure to lenalidomide (Revlimid), a thalidomide analogue. Despite being resource-intensive, this risk management program demonstrates high compliance and patient understanding, with no reported pregnancies.
Area of Science:
- Pharmacology
- Risk Management
- Teratology
Background:
- Lenalidomide (Revlimid), an analogue of thalidomide, is a known teratogen.
- To prevent fetal exposure, lenalidomide is distributed via the restricted RevAssist program in the US.
Purpose of the Study:
- To evaluate the effectiveness of the RevAssist risk minimization program for lenalidomide.
- To assess patient and prescriber compliance and understanding of risk mitigation strategies.
Main Methods:
- Analysis of patient and prescriber registration data for the RevAssist program.
- Review of mandatory and voluntary patient surveys regarding lenalidomide risks.
- Pharmacy audit findings and incident reports (e.g., false-positive pregnancy tests).
Main Results:
- 15,584 patients registered in RevAssist during its first year.
- High compliance (>95%) with risk-minimization behaviors reported by patients.
- No reported pregnancies in female patients or partners of male patients.
- High pharmacy audit compliance and successful resolution of survey discrepancies (99%).
Conclusions:
- The RevAssist program is effective in preventing fetal exposure to lenalidomide.
- Despite being labor-intensive and costly, the program achieves high compliance and patient understanding.
- The risk management strategies implemented are successful in mitigating teratogenic risks associated with lenalidomide.
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