The U.S. Food and Drug Administration has announced changes to the Risk Evaluation and Mitigation Strategies (REMS) for romiplostim (Nplate™) and eltrombopag (Promacta™).

An FDA-initiated review has determined that while safety risks for both drugs still exist, certain restrictive requirements of the REMS programs are no longer necessary. Major changes to the REMS for both products include (taken directly from source):

• Health care professionals, hospitals, specialty care facilities, and patients are no longer required to be enrolled in the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program or the Promacta CARES Program to prescribe, dispense or receive these products. Healthcare professionals also will no longer be required to complete periodic safety forms for patients receiving Nplate or Promacta.

• Pharmacies/pharmacists no longer are required to enrol in the Promacta CARES Program or verify prescriber and patient enrolment before dispensing Promacta.

• The modified REMS programs will include a communication plan that will inform health care professionals about the changes to the REMS and the safety risks associated with each product.

Healthcare professionals and patients should also be aware that:

• The warnings and precautions sections of the product labels have been updated to reflect the current understanding of the safety of the drugs. 

• Healthcare professionals should continue to refer to the drug prescribing information for the latest recommendations on prescribing Nplate and Promacta and report adverse events for both products to the FDA MedWatch program.

• Patients should read the Medication Guide that they receive with their Nplate or Promacta prescription and contact their healthcare professional regarding any questions or concerns.