Nexus Nplate® (romiplostim)

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	Healthcare Professional
	Nplate^® NEXUS Program Healthcare Provider Enrollment Form Nplate^® NEXUS Institution Enrollment Form The FDA Safety Information and Adverse Event Reporting Program - MedWatch Form Nplate^® NEXUS Healthcare Professional Brochure Nplate^® NEXUS Program Discontinuation/Post-Discontinuation Follow-up Form Nplate^® NEXUS Program: Bone Marrow Reticulin/Bone Marrow Fibrosis Form Nplate^® NEXUS Program: Hematological Malignancy/MDS Form Nplate^® NEXUS Program: Medication Errors Associated with Serious Outcomes Form Nplate^® NEXUS Program: Worsened Thrombocytopenia after Cessation of Treatment with Nplate^® Form Nplate^® NEXUS Program: Thrombotic/Thromboembolic Complication Form
	Patient
	Nexus^® Patient Enrollment Form Nexus^® Patient Brochure Nplate^®NEXUS Safety Questionnaire Nexus^® Patient Baseline Data Form Nplate^® NEXUS Program Patient Medication Guide The Nplate^® NEXUS Program Introductory Letter (Spanish Version) The Nplate^® NEXUS Program Patient Enrollment Form (Spanish Version) The Nplate^® NEXUS Program Patient Brochure (Spanish Version) Nplate^® NEXUS Program Patient Medication Guide (Spanish Version)

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.