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 Celgene for 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® (thalidomide) Patient-Physician Agreement Form with each patient and sends to Celgene

  • The prescriber/patient completes applicable mandatory confidential survey

  • The prescriber obtains an authorization number from Celgene 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 Celgene for the THALOMID REMS® program

  • The certified pharmacy must obtain a confirmation number from Celgene 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 Celgene Customer Care Center at 1-888-423-5436

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