ERWINAZE(asparaginase Erwinia chrysanthemi)for injection, intramuscular (IM) or intravenous (IV)
ERWINAZE(asparaginase Erwinia chrysanthemi)for injection, intramuscular (IM) or intravenous (IV) use
ERWINAZE Rx
Generic Name and Formulations:
Asparaginase Erwinia chrysanthemi 10,000 IU; per vial; lyophilized pwd for IM or IV inj after reconstitution.
Company:
Jazz Pharmaceuticals plc
Leukemias, lymphomas, and other hematologic cancers:
Indications for ERWINAZE:
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.
Adults and Children:
Give by IM inj (max 2mL/inj site) or IV (infuse over 1hr). 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.
Contraindications:
History of serious pancreatitis, thrombosis, hemorrhagic events with prior L-asparaginase therapy.
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 ≥2XULN 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. Pregnancy (Cat.C). Nursing mothers: not recommended.
Pharmacologic Class:
Asparagine-specific enzyme.
Adverse Reactions:
Systemic hypersensitivity, hyperglycemia, abnormal transaminases, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, diarrhea.
How Supplied:
Vials (3mL)—5
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30bdf2ea-008b-4cbb-81e4-c3474f2ad286 |
