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asparaginase (Discontinued)Brand and Other Names:Elspar, L Asparaginase

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 10,000 International Units
more...

Acute Lymphocytic Leukemia

Asparaginase is discontinued as of 8/3/2012 and supply is expected to be exhausted by approximately 12/31/2012

Discontinued worldwide because manufacturer unable to guarantee supply

Single agent treatment

  • 200 International Units/kg/day IV x 28 days

Combo treatment with prednisone, vincristine

  • 1000 International Units/m²/day IV for 10 days OR
  • 6000 International Units/m² IV/IM q3Days x 9 doses
  • High dose (Off-label): 10,000 units/m²/day for 3-12 doses

Acute Myeloid Leukemia (Orphan)

Orphan designation for the treatment of acute myeloid leukemia

Orphan sponsor

  • ERYTECH Pharma S.A; Batiment Adenine 60, avenue Rockefeller; Lyon 69008 France

Monitor

CBC, serum amylase, LFTs

Administration

IV infuse >30 minutes

Discontinue at first sign of pancreatitis

See also pegaspargase

Dosage Forms & Strengths

powder for injection

  • 10,000 International Units
more...

Acute Lymphocytic Leukemia

Asparaginase is discontinued as of 8/3/2012 and supply is expected to be exhausted by approximately 12/31/2012

Discontinued worldwide because manufacturer unable to guarantee supply

Single agent treatment: 200 International Units/kd/day IV x 28 days

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Interactions

Interaction Checker

asparaginase and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Abdominal cramps (70%)

            Anorexia (70%)

            Azotemia (66%)

            Nausea (50-60%)

            Vomiting (50-60%)

            Agitation (10-60%)

            Depression (10-60%)

            Fatigue (10-60%)

            Fever (10-60%)

            Chills (10-60%)

            Anaphylaxis (15-35%)

            Coma (25%)

            Confusion (25%)

            Somnolence (25%)

            Stupor (25%)

            Pancreatitis, acute (15%)

            1-10%

            Hyperglycemia

            Stomatitis

            Hyperuricemia

            <1%

            Disorientation

            Drowsiness

            Hallucination

            Headache

            Hyperthermia

            Parkinsonian symptoms

            Venous thrombosis

            Hypotension

            Intracranial hemorrhage

            Cerebrovascular hemorrhage

            Peripheral edema

            Thrombosis

            Cough

            Hypofibrinogenemia

            Depression of clotting factors

            Severe protein C deficiency

            Decrease antithrombin III

            Glucosuria

            Hemorrhagic pancreatitis

            Ketoacidosis

            Hepatotoxicity

            Urticaria

            Weight loss

            Acute renal failure

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            Warnings

            Contraindications

            Hypersensitivity

            History of pancreatitis, thrombosis, or serious pancreatitis events with prior L-asparaginase treatment

            Cautions

            Anaphylaxis and other serious allergic reactions can occur; observe patients for 1 hr after administration

            Serious thrombotic events, including sagittal sinus thrombosis, can occur

            Pancreatitis, in some cases fulminant or fatal, can occur

            Glucose intolerance, in some cases irreversible, can occur

            Coagulopathy can occur

            Hepatotoxicity including hepatic failure can occur

            Posterior Reversible Encephalopathy Syndrome (PRES) reported

            Do not interchange with Erwinia asparaginase or pegylated E. coli asparaginase

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: It is not known whether this drug is excreted in milk. Because of the potential for serious adverse reactions in nursing infants from Elspar, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Depletes asparagine, which is needed by leukemic cells for DNA synthesis; cycle specific for G1 phase

            Pharmacokinetics

            Vd: 4-5 L/kg

            Half-life: 39-49 hr (IM); 8-30 hr (IV)

            Peak plasma time: 14-24 hr (IM)

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            Administration

            IM administration greatly reduces incidence of anaphylaxis

            IV Compatibilities

            Y-site: methotrexate, Na-bicarb

            IV Preparation

            IV: reconstitute with SWI or NS to obtain 2000 IU/mL solution

            IM: reconstitute with 2 mL NS

            Refrigerate & use within 8 hr

            IV/IM Administration

            IV: Administered over no less than 30 min through the sidearm of a running infusion of NS or D5W

            IM: Administered in volume no greater than 2 mL; larger volumes require 2 injection sites

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