About the POMALYST REMS program

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

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

Key points of the POMALYST REMS program

Prescriber

  • The prescriber enrolls and becomes certified with the POMALYST REMS program
  • The prescriber counsels patient on benefits and risks of POMALYST
  • 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 POMALYST Patient-Physician Agreement Form with each patient and sends to the POMALYST REMS
  • The prescriber/patient completes applicable mandatory confidential survey
  • The prescriber obtains an authorization number from the POMALYST 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 POMALYST prescription to a certified pharmacy

Pharmacy

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

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

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