Approved Risk Evaluation and Mitigation Strategies (REMS)

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Nplate (romiplostim)
BLA #125268
REMS last update: 12/06/2011



What is the purpose of the REMS?

To inform healthcare providers about the risks of progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML), thrombotic/thromboembolic complications, bone marrow reticulin formation, bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, and Nplate medication errors associated with serious outcomes.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s).

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Nplate REMS, see the DailyMed link(s).
Material Name Material Name Link
Dear Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _DEAR HEALTHCARE PROFESSIONAL LETTER .pdf
Dear Professional Society Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _DEAR PROFESSIONAL SOCIETY LETTER.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06 _REMS DOCUMENT.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Nplate_2011-12-06_Full.pdf

What updates have been made to the REMS?

Date Summary of change
12/06/2011 Modified to:

  1. Make revisions to the labeling for Nplate (romiplostim) in the Package insert and Medication Guide.
  2. Eliminate the elements to assure safe use (ETASU), the Medication Guide, and the implementation system from the REMS.
  3. Provide for the dissemination of information about the REMS modification eliminating the requirement for the ETASU, about how to obtain Nplate (romiplostim), and reminding prescribers about the serious risks associated with Nplate (romiplostim) and appropriate patient selection in the Communication Plan.
07/21/2011 Modified to include information about the risk of progression from Myelodysplastic Syndrome (MDS) to acute leukemia in patients with MDS who are treated with Nplate®(romiplostim) and information about a higher risk of blood clots in the veins of the liver in patients who have chronic liver disease and are treated with Nplate® (romiplostim) in the Medication Guide.
03/23/2010 Modified to make revisions to the Nplate NEXUS Program Patient Baseline Safety Data Form, the NEXUS Program Patient Enrollment form, the NEXUS Program Healthcare Provider Enrollment Form, and the NEXUS Program Institutional Enrollment Form and the NEXUS Program Dose Calculator.
08/14/2009 Modified to add the Nplate NEXUS Program risk-specific safety questionnaires to the Nplate NEXUS website.
08/22/2008 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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