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Elspar

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Elspar

Elspar

Elspar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Elspar (asparaginase) is used to treat acute lymphocytic lymphoma. It is an antineoplastic (anticancer) medication. Common side effects include pain or swelling at the injection site, nausea or vomiting (may be severe), stomach cramps, loss of appetite, headache, lack of energy, or drowsiness.

The recommended dose of Elspar is 6,000 International Units/m 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Elspar in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • increased thirst or urination;
  • agitation, hallucinations, seizure (convulsions);
  • tremors, muscle stiffness; or
  • urinating more or less than usual, or not at all.

Less serious side effects may include:

  • mild skin rash or itching;
  • depression, drowsiness;
  • swelling in your hands, ankles, or feet;
  • nausea, vomiting, loss of appetite, weight loss;
  • stomach cramps; or
  • headache, feeling tired or irritable.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Elspar Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain or swelling at the injection site, nausea, vomiting, stomach cramps, loss of appetite, headache, lack of energy, or drowsiness may occur. Nausea and vomiting can be severe, and in some cases you may need anti-nausea drugs. Not eating before your treatment may help relieve nausea and vomiting. Changes in diet, such as eating several small meals, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: severe stomach pain with nausea/vomiting, mental/mood changes, tremor, muscle stiffness, joint pain, swelling of hands/feet/lower legs, yellowing of the eyes/skin, unusual bleeding/bruising (such as nose bleeds, black or bloody stools), unusual thirst, frequent urination, change in the amount of urine.

Get medical help right away if any of these rare but very serious side effects occur: abnormally high fever, vision changes, fainting, severe headache, severe dizziness, seizures, chest pain.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, sores in mouth or on lips, or persistent sore throat.

A very serious allergic reaction to this drug is unlikely. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Elspar (Asparaginase)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Elspar FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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