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