Elspar Side Effects
Generic Name: asparaginase escherichia coli
Note: This document contains side effect information about asparaginase escherichia coli. Some of the dosage forms listed on this page may not apply to the brand name Elspar.
For the Consumer
Applies to asparaginase escherichia coli: injection solution reconstituted
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Feeling confused.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Chest pain or pressure.
- Shortness of breath.
- Very bad headache.
- Feeling very tired or weak.
- Very bad dizziness or passing out.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
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]
Gastrointestinal side effects have included nausea, vomiting, and anorexia. Acute hemorrhagic pancreatitis (sometimes fatal) has also been reported.[Ref]
General side effects include chills, fever, abdominal cramps, weight loss, and headache. Fatal hyperthermia has also 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]
Dermatologic side effects have included skin rashes and urticaria.[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. Keung YK, Rizk R, Wu XY, Cobos E "Drug-induced hypertriglyceridemia with and without pancreatitis." South Med J 92 (1999): 912-4
4. "Product Information. Elspar (asparaginase)." Merck & Co, Inc, West Point, PA.
Some side effects of Elspar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
More about Elspar (asparaginase escherichia coli)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- 0 Reviews – Add your own review/rating
- Drug class: miscellaneous antineoplastics
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