Nplate™ is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins
or splenectomy.

Nplate™ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate™ should not be used in an attempt to normalize platelet counts.


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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