Acute Hemolytic Reactions Reported in ITP Patients Treated with Rho (D) Immune Globulin: Symptom Onset and Does Prior Exposure Lessen the Risk?
| Autor: | Carmen Muller, Gregg Little, Kristen Hess, Chris Sinclair |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Pediatrics
medicine.medical_specialty biology business.industry Bilirubin Urinary system Immunology Haptoglobin Cell Biology Hematology medicine.disease Biochemistry Gastroenterology Rho(D) immune globulin Hemolysis chemistry.chemical_compound chemistry Internal medicine medicine biology.protein Hemoglobinuria Hemoglobinemia Antibody business medicine.drug |
| Zdroj: | Blood. 118:4670-4670 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood.v118.21.4670.4670 |
| Popis: | Abstract 4670 BACKGROUND: Acute hemolytic reactions (AHR) associated with administration of Rho (D) Immune Globulin (RhIG; WinRho® SDF, Cangene Corporation, Winnipeg, Canada) have been infrequently reported during the previous 16 years. AHR were defined as any case reported with signs of hemolysis (hemoglobin decrease, haptoglobin decrease, LDH increase, elevation of bilirubin, etc.) occurring within hours to a number of days after RhIG administration irrespective of the degree of change from baseline. Intravascular hemolysis (IVH) was defined as a specific type of AHR in which plasma or urinary hemoglobin were positive. The reporting rate of AHR (including IVH) among RhIG-treated patients was previously estimated as 1/946 doses (0.11%), while the estimated reporting rate of IVH was 1/3,271 doses (0.03%).1 Reports surrounding the clinical monitoring of such patients have led to the analysis of AHR post-marketing data. AIMS/PURPOSE: Identify the onset of AHR/IVH symptoms relative to RhIG and determine if prior exposure to RhIG mitigates the risk of such events. METHODS: Retrospective evaluation of AHR (AEs reported with signs of hemolysis; including IVH) from the Cangene post-marketing surveillance database. RESULTS: CONCLUSION: Of the ITP patients who developed IVH, 40% reported an onset of symptoms within 4 hours of RhIG infusion; an additional 10% reported symptoms within 8 hours. The symptom onset was unidentified in 18% of IVH cases. In addition, previous uneventful administration of RhIG did not preclude the possibility of an occurrence of IVH and its complications following subsequent administration of RhIG; however, the majority (approx 84%) of reports of IVH were among RhIG naïve patients. Disclosures: Muller: Cangene: Employment. Little:Cangene: Employment. Hess:Cangene: Employment. Sinclair:Cangene: Employment. |
| Databáze: | OpenAIRE |
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