About the THALOMID REMS^® program

THALOMID^® (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).

THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

To avoid embryo-fetal exposure, THALOMID 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