FDA Modifies REMS Requirements for Nplate and Promacta

The FDA has modified the requirements for the Risk Evaluation and Mitigation Strategy (REMS) Programs for Nplate (romiplostim; Amgen) and Promacta (eltrombopag; GlaxoSmithKline). An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks.

Prescribing physicians, patients, pharmacies, and other health care institutions are no longer required to enroll in the safety-monitoring program — called the Nplate NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program or the Promacta CARES Program — in order to prescribe or receive Nplate or Promacta.

A modified REMS communication plan will remain in place. In addition, the Medication Guide will no longer be part of the REMS, but will be part of the approved-product labeling. The Warnings and Precautions sections of the product labeling have been updated to reflect the current understanding of the safety of the drugs.

Nplate and Promacta are both approved for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

For more information, visit www.fda.gov/Drugs/DrugSafety/ucm280165.htm.