Nplate™ (romiplostim) is the first and only platelet producer approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult chronic immune thrombocytopenic purpura (ITP). ITP is an autoimmune disorder characterized by low platelet counts in the blood (a condition known as thrombocytopenia) and an increased risk of bleeding. In adults, ITP is often a chronic condition with serious consequences. Nplate™, also the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a completely new treatment approach for this chronic disease.

Unlike most current treatments used to treat chronic ITP, which work to prevent platelet destruction, Nplate™ works by actually increasing platelet production at a rate that outpaces their destruction by the immune system.  Platelets, also called thrombocytes, are specialized blood cells needed to prevent bleeding.

Important Safety Information

Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation. Additional risks include Bone Marrow Fibrosis, Thrombotic/Thromboembolic Complications, Lack or Loss of Response to Nplate, and Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS).

Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP

Nplate™ is available only through a restricted distribution program called Nplate™ NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program.

In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.

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