A Comprehensive Risk Minimization Programme for Preventing Fetal Exposure to Lenalidomide


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.

This is a preview of subscription content, access via your institution.

Fig. 1
Table I
Table II
Table III
Table IV
Table V
Table VI
Table VII
Table VIII


  1. 1.

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


  1. 1.

    Revlimid [package insert]. Summit (NJ): Celgene Corporation, 2007

  2. 2.

    Christian MS, Laskin OL, Sharper V, et al. Evaluation of the developmental toxicity of lenalidomide in rabbits. Birth Defects Res (Part B) 2007; 80: 188–207

    Article  CAS  Google Scholar 

  3. 3.

    FDA. Food and Drug Administration guidance for industry: premarketing risk assessment [online]. Available from URL: [Accessed 2007 Jul 5]

  4. 4.

    FDA. Food and Drug Administration guidance for industry: development and use of risk minimization action plans [online]. Available from URL: [Accessed 2007 Jul 5]

  5. 5.

    FDA. Food and Drug Administration guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment [online]. Available from URL: [Accessed 2007 Jul 5]

  6. 6.

    Uhl K, Trontell A, Kennedy D. Risk minimization practices for pregnancy prevention: understanding risk, selecting tools. Pharmacoepidemiol Drug Saf 2007; 16: 337–48

    PubMed  Article  Google Scholar 

  7. 7.

    Zeldis JB, Williams BA, Thomas SD, et al. S.T.E.P.S.: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther 1999; 21(2): 319–30

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Uhl K, Cox E, Rogan R, et al. Thalidomide use in the US: experience with pregnancy testing in the S.T.E.P.S. programme. Drug Saf 2006; 29(4): 321–9

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Segal EA, Valette C, Oster L, et al. Risk management strategies in the postmarketing period: safety experience with the US and European Bosentan Surveillance Programmes. Drug Saf 2005; 28(11): 971–80

    PubMed  Article  Google Scholar 

  10. 10.

    Honein M, Lindstrom JA, Kweder SL. Can we ensure the safe use of known human teratogens? The iPLEDGE test case. Drug Saf 2007; 30(1): 5–15

    PubMed  Article  CAS  Google Scholar 

  11. 11.

    Stenman UH, Alfthan H, Ranta T, et al. Serum levels of human chorionic gonadotrophin in nonpregnant women and men are modulated by gonadotrophin-releasing hormone and sex steroids. J Clin Endocrinol Metab 1987; 64: 730–6

    PubMed  Article  CAS  Google Scholar 

  12. 12.

    Snyder J, Haymond S, Parvin C, et al. Diagnostic considerations in the measurement of human chorionic gonadotrophin in aging women. Clin Chem 2005; 51: 1830–5

    PubMed  Article  CAS  Google Scholar 

Download references


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.

Author information



Corresponding author

Correspondence to Dr Carmen P. Castaneda.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Castaneda, C.P., Zeldis, J.B., Freeman, J. et al. RevAssist®. Drug-Safety 31, 743–752 (2008).

Download citation


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