About the THALOMID REMS program

To avoid embryo-fetal exposure, THALOMID® (thalidomide) is only available under a restricted distribution program called “THALOMID Risk Evaluation and Mitigation Strategy (REMS).” Only certified prescribers can prescribe THALOMID and only certified pharmacies can dispense THALOMID in the THALOMID REMS program.

In order to receive THALOMID, all patients must be enrolled in the THALOMID REMS program and agree to comply with the requirements of the THALOMID REMS program.

Key points of the THALOMID REMS program

Prescriber

  • The prescriber enrolls and becomes certified with the THALOMID REMS program
  • The prescriber counsels patient on benefits and risks of THALOMID
  • The prescriber provides contraception and emergency contraception counseling
  • The prescriber verifies negative pregnancy test for all female patients of reproductive potential
  • The prescriber completes a THALOMID Patient-Physician Agreement Form with each patient and sends to the THALOMID REMS
  • The prescriber/patient completes applicable mandatory confidential survey
  • The prescriber obtains an authorization number from the THALOMID REMS and writes it on every prescription along with patient risk category
  • The prescriber writes no more than a 4-week (28-day) supply, with no automatic refills or telephone prescriptions
  • The prescriber sends THALOMID prescription to certified pharmacy

Pharmacy

  • The pharmacy certifies with the THALOMID REMS program
  • The certified pharmacy must obtain a confirmation number from the THALOMID REMS before dispensing
  • The certified pharmacy counsels the patient, and completes the Education and Counseling Checklist
  • The certified pharmacy dispenses THALOMID to patient along with a Medication Guide

For additional information about the THALOMID REMS program, please contact the REMS Call Center at 1-888-423-5436

THALOMID and THALOMID REMS are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb Company.