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RevAssist®

A Comprehensive Risk Minimization Programme for Preventing Fetal Exposure to Lenalidomide

Abstract

Lenalidomide (Revlimid®) is an immunomodulatory drug and an analogue of thalidomide, a known teratogen. To prevent fetal exposure, in the US lenalidomide is available only under a special restricted distribution programme called RevAssist®. Under this risk minimization programme, only prescribers and contract pharmacies registered with the programme are able to prescribe and dispense the product. Patients must be advised of, agree to and comply with the requirements of the RevAssist® programme in order to receive lenalidomide through a registered prescriber. A total of 15 584 patients were registered in the RevAssist® programme during the first year lenalidomide was on the market. There were four reports of false-positive β-human chorionic gonadotrophin measurements in patients aged 43–57 years. Mandatory patient and prescriber surveys have shown discrepant responses that were resolved by risk management intervention specialists 99% of the time. The voluntary patient surveys have shown understanding of the risks of lenalidomide use and of behaviours necessary to minimize risks in >95% of females of childbearing potential and adult males. To date, there have been no reports of pregnancy in female patients or female partners of male patients. The pharmacy audit findings showed compliance with Rev Assist® was high. Although RevAssist® is labour-intensive, time-consuming and costly, it continues to be effective in preventing fetal exposure to lenalidomide.

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Notes

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    1The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The authors would like to thank Maria Luisa Salomon and her Risk Management Intervention Specialist Group for providing all the pertinent reports for this manuscript and Helen Cammisa-Parks for providing editorial support. The authors are all employees of Celgene Corporation and have stock ownership with the company. Jerome Zeldis is Chief Medical Officer at Celgene and receives remuneration for expert testimony and pending and received patents. No funding was provided for the preparation of this review.

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Correspondence to Dr Carmen P. Castaneda.

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Castaneda, C.P., Zeldis, J.B., Freeman, J. et al. RevAssist®. Drug-Safety 31, 743–752 (2008). https://doi.org/10.2165/00002018-200831090-00003

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Keywords

  • Thalidomide
  • Lenalidomide
  • Birth Control Method
  • Fetal Exposure
  • Voluntary Survey