Label Changes for:

Nplate (romiplostim)

November 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

November 2012

ADVERSE REACTIONS

Post-Marketing Experience
  • hypersensitivity and angioedema  

 

 

August 2009 

 

MEDICATION GUIDE (New)

 

REMS Goals
  • To promote informed risk-benefit decisions before initiating treatment and while patients are on treatment to ensure appropriate use of Nplate (romiplostim)
  • To establish the long-term safety and safe use of Nplate (romiplostim) through periodic monitoring of all patients who receive Nplate (romiplostim) for changes in bone marrow reticulin formation and bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, thrombotic/thromboembolic complications, hematological malignancies and progression of malignancy in patients with a pre-existing hematological malignancy or myelodysplastic syndrome (MDS), and medication errors associated with serious outcomes.

 

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