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Erwinaze Generic Name & Formulations
Legal Class
Rx
General Description
Asparaginase Erwinia chrysanthemi 10,000 IU; per vial; lyophilized pwd for IM or IV inj after reconstitution.
Pharmacological Class
Asparagine-specific enzyme.
How Supplied
Vials (3mL)—5
Manufacturer
Generic Availability
NO
Erwinaze Indications
Indications
As a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
Erwinaze Dosage and Administration
Adults and Children
<1yr: not established. ≥1yr: Give by IM inj (max 2mL/inj site) or IV (infuse over 1 to 2hrs). To substitute for a pegaspargase dose: 25,000 IU/m2 three times weekly (M/W/F) for 6 doses for each planned pegaspargase dose. To substitute for a native E. coli asparaginase dose: 25,000 IU/m2 for each scheduled native E. coli asparaginase dose within a treatment. When IV use: consider monitoring nadir serum asparaginase activity (NSAA) levels; switch to IM inj if levels are inadequate.
Erwinaze Contraindications
Contraindications
History of serious pancreatitis, thrombosis, hemorrhagic events with prior L-asparaginase therapy.
Erwinaze Boxed Warnings
Not Applicable
Erwinaze Warnings/Precautions
Warnings/Precautions
Have resuscitation equipment available and other agents necessary to treat anaphylaxis. Discontinue if serious hypersensitivity reactions occur. Monitor for pancreatitis; discontinue if severe or hemorrhagic pancreatitis manifested by abdominal pain >72hrs and amylase elevation ≥2×ULN occurs. Withhold therapy if mild pancreatitis; may resume after resolution. Monitor glucose levels at baseline and during therapy. Discontinue if thrombotic or hemorrhagic event occurs; may resume after resolution. Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).
Erwinaze Pharmacokinetics
See Literature
Erwinaze Interactions
Not Applicable
Erwinaze Adverse Reactions
Adverse Reactions
Systemic hypersensitivity, hyperglycemia, abnormal transaminases, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, diarrhea.
Erwinaze Clinical Trials
See Literature
Erwinaze Note
Not Applicable
Erwinaze Patient Counseling
See Literature
