Abstract
Abstract 4670
Acute Hemolytic Reactions (AHR) and Intravascular Hemolysis (IVH) have been reported rarely with Rh (D) Immune Globulin (WinRho® SDF) administration for normalization of platelet count in ITP. The sporadic and unpredictable occurrence of these events has led to an analysis of our WinRho® SDF safety database to identify populations that may be at higher risk for occurrence of AHR's. A disproportionality analysis revealed that malignancies were disproportionally over represented in cases with AHR compared to Non Hemolytic Reactions and was reported in another abstract.
To determine which malignancies were disproportionally overrepresented in patients who developed AHR's.
Medical Histories cases with AHR with malignancies were reviewed and classified by type of malignancy. AHR's included both the expected post infusion hemolysis and infrequently reported cases involving clinically compromising hemolysis including IVH.
Malignancy . | Age (years) . | ||||
---|---|---|---|---|---|
<17 . | 18-65 . | >65 . | Unknown . | N (% of Type) . | |
Leukemias (27%) | |||||
CLL | 0 | 5 | 4 | 0 | 9 (69%) |
ALL | 1 | 0 | 0 | 0 | 1 (8%) |
CML | 0 | 1 | 0 | 0 | 1 (8%) |
AML | 0 | 1 | 0 | 0 | 1 (8%) |
NK cell | 1 | 0 | 0 | 0 | 1 (8%) |
Lymphoma (31%) | |||||
Non Hodgkin | 0 | 6 | 6 | 1 | 13 (92%) |
Hodgkin | 0 | 0 | 0 | 0 | 0 |
Unspecified | 0 | 1 | 0 | 0 | 1 (8%) |
Proliferative Diseases (27%) | |||||
Myelodysplasia | 0 | 2 | 5 | 0 | 7 (58%) |
Plasma Cell Neoplasm | 0 | 2 | 2 | 0 | 4 (33%) |
Myeloproliferative | 0 | 0 | 0 | 1 | 1 (8%) |
Solid Tumors (14%) | 0 | 3 | 3 | 0 | 6 (100%) |
Total for Age Group (%) | 5% | 45% | 45% | 5% | 45 (100%) |
Malignancy . | Age (years) . | ||||
---|---|---|---|---|---|
<17 . | 18-65 . | >65 . | Unknown . | N (% of Type) . | |
Leukemias (27%) | |||||
CLL | 0 | 5 | 4 | 0 | 9 (69%) |
ALL | 1 | 0 | 0 | 0 | 1 (8%) |
CML | 0 | 1 | 0 | 0 | 1 (8%) |
AML | 0 | 1 | 0 | 0 | 1 (8%) |
NK cell | 1 | 0 | 0 | 0 | 1 (8%) |
Lymphoma (31%) | |||||
Non Hodgkin | 0 | 6 | 6 | 1 | 13 (92%) |
Hodgkin | 0 | 0 | 0 | 0 | 0 |
Unspecified | 0 | 1 | 0 | 0 | 1 (8%) |
Proliferative Diseases (27%) | |||||
Myelodysplasia | 0 | 2 | 5 | 0 | 7 (58%) |
Plasma Cell Neoplasm | 0 | 2 | 2 | 0 | 4 (33%) |
Myeloproliferative | 0 | 0 | 0 | 1 | 1 (8%) |
Solid Tumors (14%) | 0 | 3 | 3 | 0 | 6 (100%) |
Total for Age Group (%) | 5% | 45% | 45% | 5% | 45 (100%) |
Hematological malignancies were present in 39/45 of AHR's (86.6 %) and non-hematological malignancies 6 of 45 of AHR (13.3%). 90% of AHR's in patients with Malignancies were adult, 5% children and 5% age unknown. Adults above the age of 65 years accounted for 45% of these cases. CLL was present in 66% of patients with leukemia and Non Hodgkins Lymphoma was present in 92% of patients with Lymphomas. Proliferative disorders were diagnosed in 27% of patients with AHR. Solid tumors were present in 14% of patients with AHR's.
Hematological malignancies including CLL and NHL are disproportionally over represented in cases presenting with AHR post WinRho® SDF. Alternate therapies to Rh (D) Immune Globulin should be considered in patients with thrombocytopenia and these hematological malignancies due to increased risk of AHR, such as IVH.
Astacio:Cangene Corporation: Employment. Muller:Cangene Corporation: Employment. Little:Cangene Corporation: Employment. Sinclair:Cangene Corporation: Employment. Genereux:Cangene Corporation: Employment.
Author notes
Asterisk with author names denotes non-ASH members.
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