asparaginase Erwinia chrysanthemi

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asparaginase Erwinia chrysanthemi

(a-spare-a-ji-nase) ,

Erwinaze

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: enzymes
Pregnancy Category: C

Indications

Part of combination chemotherapy in the treatment of acute lymphocytic leukemia (ALL) in patients who developed hypersensitivity to E. coli-derived asparaginase.

Action

Catalyst in the conversion of asparagine (an amino acid) to aspartic acid and ammonia.
Depletes asparagine in leukemic cells.

Therapeutic effects

Death of leukemic cells.

Pharmacokinetics

Absorption: Is absorbed from IM sites.
Distribution: Remains in the intravascular space. Poor penetration into the CSF.
Metabolism and Excretion: Slowly sequestered in the reticuloendothelial system.
Half-life: IV: 8–30 hr; IM: 39–49 hr.

Time/action profile

ROUTEONSETPEAK†DURATION
IMunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Previous hypersensitivity;History of pancreatitis with prior L-asparaginaseHistory of serious thrombosis or hemorrhagic events with prior L-asparaginase Lactation: Lactation.
Use Cautiously in: Obstetric: Use only if the potential benefit justifies the potential risk to the fetus.

Adverse Reactions/Side Effects

Gastrointestinal

  • pancreatitis (life-threatening)
  • ↑ liver function tests
  • nausea
  • vomiting

Endocrinologic

  • hyperglycemia

Hematologic

  • hemorrhage
  • thromboembolic events

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • fever

Interactions

Drug-Drug interaction

None known

Route/Dosage

Intramuscular (Adults and Children) Substitution for E.coli-derived asparaginase—25,000 International Units/m2 substituted for each dose of E.coli-derived asparaginase; Substitution for pegasparagase—25,000 International Units/m2 3 times a week (Mon/Wed/Fri) for 6 doses substituted for each dose of pegasparagase

Availability

Powder for injection: 10,000 International Units/vial

Nursing implications

Nursing assessment

  • Monitor vital signs before and periodically during therapy; may cause fever.
  • Monitor for signs and symptoms of pancreatitis (abdominal pain, nausea, vomiting, ↑ serum amylase) during therapy. If abdominal pain > 72 hrs and serum amylase ↑ ≥ 2.0 x upper limit of normal occur, discontinue therapy. If mild pancreatitis occurs, withhold asparaginase Erwinia chrysanthemi until symptoms and serum amylase return to normal; then restart.
  • Monitor for hypersensitivity reaction (urticaria, diaphoresis, facial swelling, joint pain, hypotension, bronchospasm). Epinephrine and resuscitation equipment should be readily available.
  • Lab Test Considerations: Monitor CBC and coagulation studies before and periodically throughout therapy. May ↓ fibrinogen, protein C activity, protein S activity, and anti-thrombin III. If thrombotic or hemorrhagic event occurs, withhold asparaginase Erwinia chrysanthemi until symptoms resolve; then resume therapy.
    • Hepatotoxicity may be manifested by ↑ AST, ALT, bilirubin, or cholesterol. Liver function test results usually return to normal after therapy. May cause pancreatitis; monitor frequently for ↑ amylase or glucose.
    • Monitor blood glucose prior to and periodically during therapy. May cause hyperglycemia treatable with fluids and insulin.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order and dose calculations.
  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard equipment in specially designated containers. See.
  • Intramuscular: Prepare for IM dose by adding 1 or 2 mL of 0.9% NaCl for injection (without preservatives) against inner wall of the 10,000-IU vial. Swirl vial gently; do not shake or invert. Administer no more than 2 mL per injection site. Concentration: Reconstitution with 1 mL = 10,000 IU/mL; with 2 mL = 5,000 IU/mL. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Withdraw dose needed into a polypropylene syringe and administer within 15 min of reconstitution. Do not refrigerate or freeze; administer within 4 hrs or discard. Inject IM with no >2 mL/site. Do not save unused portions; discard.

Patient/Family Teaching

  • Instruct patient to notify health care professional if signs and symptoms of hypersensitivity reaction, pancreatitis, thrombosis or hemorrhage (headache, arm or leg swelling, shortness of breath, chest pain) or hyperglycemia (excess thirst or increase in frequency or volume of urination), occur.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breast feeding.
  • Emphasize need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Improvement of hematologic status in patients with leukemia.
References in periodicals archive ?
M2 EQUITYBITES-January 26, 2017-FDA warns Porton Biopharma over Erwinaze production
M2 PHARMA-January 26, 2017-FDA warns Porton Biopharma over Erwinaze production
In these areas, Jazz Pharmaceuticals markets Xyrem (sodium oxybate) oral solution, Erwinaze (asparaginase Erwinia chrysanthemi) and Defitelio (defibrotide sodium) in the US and markets Erwinase and Defitelio (defibrotide) in countries outside the US.
Tenders are invited for Provision Of Erwinaze & N Plate
M2 PHARMA-December 23, 2014-Jazz Pharmaceuticals receives approval for Erwinaze from US FDA
The transaction is valued at USD680m in cash, which represents a base price of USD650m and around USD30m of adjustments for EUSA's working capital, cash and certain liabilities, and a potential USD50m milestone payable based upon Erwinaze achieving a specified United States net sales target in 2013.
Erwinaze is indicated for use in combination with other anti-neoplastic agents to treat acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E.
Its marketed products include Xyrem (sodium oxybate), Erwinaze (asparaginase Erwinia chrysanthemi), Prialt (ziconotide) intrathecal infusion, FazaClo (clozapine USP) HD and LD and Luvox CR (fluvoxamine maleate).
Biopharmaceutical company Jazz Pharmaceuticals plc (JAZZ) and EUSA Pharma Inc announced on Thursday that the companies have signed a definitive agreement under which Jazz Pharmaceuticals has agreed to acquire EUSA Pharma, a privately-held, pharmaceutical company headquartered in the US and UK, for USD650m in cash and a potential USD50m milestone payable in cash based upon its lead product, Erwinaze (asparaginase Erwinia chrysanthemi), achieving a specified US net sales target in 2013.
M2 EQUITYBITES-December 23, 2014-Jazz Pharmaceuticals receives approval for Erwinaze from US FDA
With this acquisition, Jazz adds Erwinaze, a treatment for patients that suffer from acute lymphoblastic leukemia, to its US product portfolio.
22 November 2011 - US contract research organisation AIBioTech LLC said Tuesday it had completed an assay validation and sample analysis programme as part of EUSA Pharma's Biologics Licence Application (BLA) with the US Food and Drug Administration (FDA) for EUSA's drug product Erwinaze (asparaginase Erwinia chrysanthemi).