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.
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.