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.

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.

For the Consumer

Applies to asparaginase escherichia coli: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking asparaginase escherichia coli (the active ingredient contained in Elspar) hives; difficulty breathing; swelling with or without pain in your arms and legs; swelling of your face, lips, tongue, or throat.

Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again.

Call your doctor at once if you have:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• easy bruising or bleeding, unusual weakness;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• headache, confusion, change in mental status, vision loss, seizure (convulsions); or

• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• increased thirst and urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to asparaginase escherichia coli: 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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