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On December 6, 2011, the Food and Drug Administration (FDA) approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for romiplostim (Nplate for subcutaneous injection, Amgen Inc.) and eltrombopag (Promacta tablets, GlaxoSmithKline LLC) to remove the restricted distribution programs and the safety reporting requirements that were part of the REMS. Prescriber, institution, pharmacy, and patient enrollment and these data collection requirements are no longer necessary.
Since the approval of Nplate and Promacta in 2008, FDA has been concerned about specific risks associated with Nplate and Promacta, including bone marrow changes of reticulin or collagen deposition, higher risk for blood clots, progression of myelodysplastic syndrome to acute leukemia, and further lowering of platelet counts and risk of bleeding shortly after discontinuing the drugs. Healthcare professionals and patients should be aware that these serious risks still exist with Nplate and Promacta, and note that the physician prescribing information and patient Medication Guides have been updated to reflect the current perspective on the risks associated with each drug.
Underlying medical conditions in the treated patient population confounded the safety data collected by the REMS programs. Therefore, FDA and the sponsors have determined that it is no longer necessary to continue collecting safety data within the REMS or to continue the restricted distribution of the drugs. Establishing the long-term safety of Nplate and Promacta is optimally achieved through ongoing clinical trials, post-approval studies, and post-marketing adverse event reporting.
Major modifications to the REMS programs include the following:
Healthcare professionals are no longer required to:
Be enrolled in the Nplate NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program to prescribe Nplate.
Be enrolled in the Promacta CARES Program to prescribe Promacta.
Enroll patients to the Nplate NEXUS Program or Promacta CARES Program in order to receive Nplate or Promacta.
Complete Safety Forms for patients receiving Nplate or Promacta.
Institutions are no longer required to:
Enroll in the Nplate NEXUS Program.
Verify prescriber and patient enrollment before dispensing Nplate.
Pharmacies/pharmacists are no longer required to:
Enroll in the Promacta CARES Program.
Verify prescriber and patient enrollment before dispensing Promacta.
Healthcare professionals should continue to refer to the drug prescribing information for the latest recommendations on prescribing Nplate and Promacta.
Healthcare professionals should encourage patients to read the Medication Guide.
Healthcare professionals and patients should continue to report adverse events involving Nplate or Promacta to the FDA MedWatch program (see below).
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 about Nplate or Promacta.
Full prescribing information for Nplate is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf
Full prescribing information for Promacta is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).