Elspar Side Effects

Please note - some side effects for Elspar 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 Elspar - for the Consumer

Elspar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elspar:

Agitation; chills; confusion; depression; drowsiness; fatigue; fever; headache; hives; irritability; joint pain; loss of appetite; muscle pain; nausea; rash; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Elspar:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in the amount of urine; coma; confusion; dark urine; hallucinations; high fever; joint pain; pain, redness, or swelling at the injection site; seizures; stomach pain; tremor; unusual bruising or bleeding; unusual tiredness or weakness.

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.

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Elspar Side Effects - for the Professional

Elspar

The following serious adverse reactions occur with Elspar treatment [see Warnings and Precautions (5)]:

• Anaphylaxis and serious allergic reactions
• Serious thrombosis
• Pancreatitis
• Glucose intolerance
• Coagulopathy
• Hepatotoxicity and abnormal liver function

The most common adverse reactions with Elspar are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

Clinical Trials and Post-Marketing Experience

The adverse reactions included in this section were identified in single-arm clinical trials in which Elspar was administered as part of a multi-agent regimen or from spontaneous post-marketing reports or published literature.

Because these adverse events were identified in clinical trials that were not designed to isolate the adverse effects of Elspar or were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serious Adverse Reactions

Anaphylaxis and serious allergic reactions. Allergic reactions have occurred with the first dose and with subsequent doses of Elspar. The risk of serious allergic reactions appears to be higher in patients with prior exposure to Elspar or other Escherichia coli-derived L-asparaginases.

Serious thrombosis, including sagittal sinus thrombosis

Pancreatitis, in some cases fulminant or fatal

Glucose intolerance, in some cases irreversible

Coagulopathy, including increased prothrombin time, increased partial thromboplastin time, and decreased fibrinogen, protein C, protein S and antithrombin III. CNS hemorrhages have been reported.

Hepatotoxicity, in some cases fatal, can occur.

Central Nervous System effects including coma, seizures, and hallucinations.

Common Adverse Reactions

Azotemia, liver function abnormalities, including hyperbilirubinemia, and elevated transaminases.

Other

Hyperlipidemia including hypertriglyceridemia and hypercholesterolemia

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity, defined as development of binding and/or neutralizing antibodies to the product.

Elspar is a bacterial protein and can elicit antibodies in patients treated with the drug. In 2 prospectively designed clinical trials (N=59 and 24), approximately one quarter of the patients developed antibodies that bound to Elspar as measured by enzyme-linked immunosorbent assays (ELISA). Clinical hypersensitivity reactions to Elspar in studies were common ranging from 32.5% to 75%. In these studies, concomitant medications and dosing schedules varied. Patients with hypersensitivity reactions were more likely to have antibodies than those without hypersensitivity reactions. Hypersensitivity reactions have been associated with increased clearance of Elspar. Incidence of antibody formation was lower upon first administration of Elspar than second administration. The frequency of antibody formation in adults relative to children is unknown. There is insufficient information to comment on neutralizing antibodies; however, higher levels of antibody correlated with a decrease in asparaginase activity.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications and underlying disease. Therefore, comparison of the incidence of antibodies to Elspar with the incidence of antibodies to other products may be misleading.

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Side Effects by Body System - for Healthcare Professionals

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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