BRIEF SUMMARY OF PRESCRIBING INFORMATION
Nplate (romiplostim), for subcutaneous injection
®
WARNINGS AND PRECAUTIONS
Risk of Progression of Myelodysplastic Syndromes to Acute
Myelogenous Leukemia
Progression from myelodysplastic syndromes (MDS) to
acute myelogenous leukemia (AML) has been observed
in clinical trials with Nplate®. A randomized, double-blind,
placebo-controlled trial enrolling patients with severe
thrombocytopenia and International Prognostic Scoring
System (IPSS) low or intermediate-1 risk MDS was terminated
due to more cases of AML observed in the Npla ї