The Food and Drug Administration (FDA) has modified the Risk Evaluation and Mitigation (REMS) for Lotronex (alosetron HCl; Sebela) indicated for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. 

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Changes to the REMS program include:

    — Prescribers no longer need to affix prescribing program stickers to written prescriptions for Lotronex or Alosetron HCl

    — Pharmacies no longer need to only dispense Lotronex or Alosetron HCl for a paper prescription with an affixed prescribing program stickerv

    — Electronic prescriptions are now allowed 

    — Patients no longer need to complete and submit a Patient Acknowledgment Form; a Patient Education Sheet is now available for the prescriber to discuss with the patient

Lotronex is available as 0.5mg and 1mg strength tablets in 30-count bottles. 

For more information call (844) 732-3521 or visit LotronextREMS.com.