Chronic ITP Important Safety Information

August 6, 2010

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