Asparaginase Side Effects

Please note - some side effects for Asparaginase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Asparaginase - for the Consumer

Asparaginase

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with asparaginase. Seek medical attention right away if any of these SEVERE side effects occur when using Asparaginase:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf, leg, or arm pain, swelling, redness, or tenderness; chest pain; confusion; coughing up blood; fever; headache; one-sided weakness; pain, redness, or swelling at the injection site; seizures; shortness of breath; slurred speech; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing; rapid breathing; fruit-like breath odor); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bleeding or bruising; vision problems; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: injectable powder for injection

Hematologic

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.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and anorexia. Acute hemorrhagic pancreatitis (sometimes fatal) has also been reported.

General

General side effects include chills, fever, abdominal cramps, weight loss, and headache. Fatal hyperthermia has also been reported.

Hepatic

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.

Most hepatic abnormalities are usually reversible upon discontinuation of therapy and some reversal has been reported during the course of therapy.

Nervous system

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.

Nervous system side effects have usually reversed spontaneously upon discontinuation of asparaginase.

Cardiovascular

Cardiovascular side effects have included one reported case of acute myocardial infarction.

Dermatologic

Dermatologic side effects have included skin rashes and urticaria.

Musculoskeletal

Musculoskeletal side effects have included arthralgia.

Respiratory

Respiratory side effects have included respiratory distress.

Metabolic

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.

Metabolic side effects have included a low incidence of hyperglycemia with glycosuria and polyuria.

Psychiatric

Psychiatric side effects have included depression, agitation, confusion, paranoia, and hallucinations.

Renal

Renal side effects include acute renal shut down and fatal renal insufficiency. Proteinuria has been reported infrequently.

Other

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.

Serum concentrations of thyroxine-binding globulin have been reported to return to pretreatment values within four weeks of the last dose.

Oncologic

Oncologic side effects have included reports of small increases in pulmonary adenomas in animal studies..

Immunologic

Immunosuppressive activity has been reported in animal experiments.

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