RevAssist: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide.

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Carmen P CastanedaRobert Bwire

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 beta-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 ma...Continue Reading

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Citations

Nov 19, 2009·BioEssays : News and Reviews in Molecular, Cellular and Developmental Biology·Neil Vargesson
Feb 22, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Inge M ZomerdijkSabine M J M Straus
Sep 13, 2020·Birth Defects Research·Wejdan A ShroukhSarah C Willis
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Feb 18, 2010·Journal of Clinical Pharmacology·Nianhang ChenOscar L Laskin
Feb 1, 2014·Oncoimmunology·Michaela SemeraroLorenzo Galluzzi
Jan 12, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Nancy A BrandenburgJerome B Zeldis
Nov 7, 2017·British Journal of Clinical Pharmacology·Thomas GoedeckeXavier Kurz
Apr 6, 2019·Therapeutic Innovation & Regulatory Science·Jennifer ChapmanPaul Sheehan
Dec 21, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Anjan Kumar BanerjeeStephen J Mayall
Mar 15, 2021·Current Problems in Cancer·Masato KomuroHiroyuki Terakado

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