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Elspar

Last reviewed on RxList: 4/7/2017
Elspar Side Effects Center

Last reviewed on RxList 1/29/2016

Elspar (asparaginase) is an antineoplastic (anticancer) medication used to treat acute lymphocytic lymphoma. Common side effects of Elspar include pain or swelling at the injection site, nausea or vomiting (may be severe), stomach cramps, loss of appetite, weight loss, headache, lack of energy, drowsiness, skin rash or itching, depression, swelling in your hands, ankles, or feet, headache, tiredness, or irritability.

The recommended dose of Elspar is 6,000 International Units/m² intramuscularly (IM) or intravenously (IV) three times a week. Elspar may interact with vincristine, prednisone, or methotrexate. Tell your doctor all medications and supplements you use. Elspar should be used only when prescribed during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Women should use birth control while using this medication. It is unknown if this medication passes into breast milk. Because of the potential risk to the infant, breastfeeding while using this drug is not recommended.

Our Elspar (asparaginase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Elspar Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • any bleeding that will not stop;
  • fever;
  • seizure (convulsions);
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs; or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Common side effects may include:

  • mild nausea;
  • diarrhea; or
  • mild stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Elspar (Asparaginase)

Elspar Professional Information

SIDE EFFECTS

The following serious adverse reactions occur with Elspar treatment [see WARNINGS AND PRECAUTIONS]:

  • Anaphylaxis and serious allergic reactions
  • Serious thrombosis
  • Pancreatitis
  • Glucose intolerance
  • Coagulopathy
  • Hepatotoxicity and abnormal liver function
  • Posterior Reversible Encephalopathy Syndrome (PRES)
  • Risk of Medication Errors

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

Hyperammonemia, diabetic ketoacidosis, and 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.

Read the entire FDA prescribing information for Elspar (Asparaginase)

Related Resources for Elspar

Related Health

© Elspar Patient Information is supplied by Cerner Multum, Inc. and Elspar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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