Asparaginase escherichia coli Side Effects
Applies to asparaginase escherichia coli: injectable powder for injection
Hematologic side effects have included a marked decrease in circulating lymphoblasts, with normal or below normal leukocyte counts, within the first days after initiating therapy. This is sometimes accompanied by a marked rise in serum uric acid. Pre-renal azotemia has also been reported.
Hypofibrinogenemia has been reported. Depression of other clotting factors including factors V and VIII (marked decreases) and factors VII and IX (variable decreases) have also been reported. A low incidence of decrease in circulating platelets has been reported. Bleeding has been reported in a minority of patients with a demonstrable coagulopathy. Intracranial hemorrhage and fatal bleeding associated with low fibrinogen levels have been reported. Compensatory increased fibrinolytic activity has also been reported.
Transient bone marrow depression has rarely been observed as evidenced by a delay in return of hemoglobin or hematocrit levels to normal in patients undergoing hematologic remission of leukemia. Marked leukopenia has also been reported.
Hypertriglyceridemia has been reported.[Ref]
Most hepatic abnormalities are usually reversible upon discontinuation of therapy and some reversal has been reported during the course of therapy.[Ref]
Hepatic side effects have included elevations of SGOT, SGPT, alkaline phosphatase, bilirubin, and depression of serum albumin, cholesterol, and plasma fibrinogen. Both increases and decreases in total blood lipids have been reported. Marked hypoalbuminemia associated with peripheral edema has been reported. Fatty changes in the liver have been documented by biopsy. Malabsorption syndrome has also been reported.[Ref]
Nervous system side effects have usually reversed spontaneously upon discontinuation of asparaginase.[Ref]
Nervous system side effects have included somnolence, fatigue, seizures, coma, and confusion. A Parkinson-like syndrome with tremor and a progressive increase in muscle tone has been reported rarely.[Ref]
Cardiovascular side effects have included one reported case of acute myocardial infarction.[Ref]
Musculoskeletal side effects have included arthralgia.[Ref]
Respiratory side effects have included respiratory distress.[Ref]
Metabolic side effects have included a low incidence of hyperglycemia with glycosuria and polyuria.[Ref]
The syndrome resembles hyperosmolar nonketonic hyperglycemia. While the syndrome usually responds to discontinuation of asparaginase, judicious use of IV fluid, and insulin, it has occasionally been fatal.[Ref]
Psychiatric side effects have included depression, agitation, confusion, paranoia, and hallucinations.[Ref]
Renal side effects include acute renal shut down and fatal renal insufficiency. Proteinuria has been reported infrequently.[Ref]
Serum concentrations of thyroxine-binding globulin have been reported to return to pretreatment values within four weeks of the last dose.[Ref]
Other side effects have included interference with the interpretation of thyroid function tests by production of a rapid and marked reduction in serum concentrations of thyroxine-binding globulin within days after the first dose.[Ref]
Oncologic side effects have included reports of small increases in pulmonary adenomas in animal studies..[Ref]
Immunosuppressive activity has been reported in animal experiments.[Ref]
1. Fragasso G, Pastore MR, Vicari A, Chierchia SL, Pozza G "Myocardial infarction in a patient with acute lymphoblastic leukemia during L-asparaginase therapy." Am J Hematol 48 (1995): 136-7
2. Parsons SK, Skapek SX, Neufeld EJ, Kuhlman C, Young ML, Donnelly M, Brunzell JD, Otvos JD, Sallan SE, Rifai N "Asparaginase-associated lipid abnormalities in children with acute lymphoblastic leukemia." Blood 89 (1997): 1886-95
3. "Product Information. Elspar (asparaginase)." Merck & Co, Inc, West Point, PA.
4. Keung YK, Rizk R, Wu XY, Cobos E "Drug-induced hypertriglyceridemia with and without pancreatitis." South Med J 92 (1999): 912-4
Some side effects may not be reported. You may report them to the FDA.