Chronic ITP Important Safety Information
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.
Indication (Nplate® Professional Indication and "Full" Fair Balance)
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.
Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
Worsened Thrombocytopenia After Cessation of Nplate®
Thrombotic/Thromboembolic Complications
Lack or Loss of Response to Nplate®
Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS)
Laboratory Monitoring
Nplate® Distribution Program
General Safety
Please see Prescribing Information and Medication Guide
