Flexible Administration Options2

Routes of administration for ERWINAZE®

For IV administration, infuse ERWINAZE in 100 mL of normal saline over 1 to 2 hours.2

ERWINAZE is approved for IM and IV administration

  Substitute for PEG-asparaginase2
Recommended dose 25,000 IU/m2
Administration Intramuscular/Intravenous
Dosing schedule 6 doses for each planned dose, 3 times a week (Mon/Wed/Fri)

Half-life chart

The half‐life of ERWINAZE varies between the 2 routes of administration. Based on a population pharmacokinetic model, the mean half‐life of ERWINAZE IM was 0.65 days (15.6 hours) and the mean half‐life of ERWINAZE IV was 0.31 days (7.51 hours).2

When administering ERWINAZE intravenously, consider monitoring nadir (pre-dose) serum asparaginase activity (NSAA) levels and switching to intramuscular administration if desired NSAA levels are not achieved.2

In Study 2, NSAA levels were measured after each dose of ERWINAZE IV.18

Contraindications
ERWINAZE is contraindicated in patients with a history of:

  • Serious hypersensitivity reactions to ERWINAZE, including anaphylaxis
  • Serious pancreatitis with prior L-asparaginase therapy
  • Serious thrombosis with prior L-asparaginase therapy
  • Serious hemorrhagic events with prior L-asparaginase therapy

Preparation Instructions2

  1. Visually inspect the ERWINAZE powder for foreign particulate matter and discoloration prior to reconstitution. Discard vial if present.
  2. Reconstitute the contents of each vial by slowly injecting 1 or 2 mL of preservative-free sterile sodium chloride (0.9%) injection (USP) against the inner vial wall.
  3. Do not forcefully inject solution for reconstitution directly onto or into the powder. When reconstituted with 1 mL, the resultant concentration is 10,000 IU/mL. When reconstituted with 2 mL, the resultant concentration is 5,000 IU/mL.
  4. Dissolve contents by gentle mixing or swirling. Do not shake or invert vial.
  5. When reconstituted, ERWINAZE should be a clear, colorless solution. Inspect the solution after reconstitution and discard if any visible particles or protein aggregates are present.
  6. Calculate the dose needed and the volume needed to obtain the calculated dose.
  7. Withdraw the volume containing the calculated dose from the vial into a polypropylene syringe within 15 minutes of reconstitution. For intravenous use, slowly inject the reconstituted ERWINAZE into an IV infusion bag containing 100 mL of normal saline acclimatized to room temperature. Do not shake or squeeze the IV bag.
  8. If a partial vial is used, do not save or reuse the unused drug for later administration. Discard unused portions.
  9. Do not freeze or refrigerate reconstituted solution and administer within 4 hours or discard.

Administration Instructions2

  • For intramuscular use, limit the volume of reconstituted ERWINAZE at a single injection site to 2 mL; if reconstituted dose to be administered is greater than 2 mL, use multiple injection sites
  • For intravenous use, infuse ERWINAZE in 100 mL of normal saline over 1 to 2 hours. Do not infuse other intravenous drugs through the same intravenous line while infusing ERWINAZE

Indication
ERWINAZE® (asparaginase Erwinia chrysanthemi) for intramuscular injection (IM) or intravenous infusion (IV), 10,000 International Units (IU)/vial, is indicated 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.

IMPORTANT SAFETY INFORMATION

Contraindications
ERWINAZE is contraindicated in patients with a history of:

  • Serious hypersensitivity reactions to ERWINAZE, including anaphylaxis
  • Serious pancreatitis with prior L-asparaginase therapy
  • Serious thrombosis with prior L-asparaginase therapy
  • Serious hemorrhagic events with prior L-asparaginase therapy

Warnings and Precautions
Hypersensitivity Reactions
After the use of ERWINAZE in clinical trials, grade 3 and 4 hypersensitivity reactions have occurred in 5% of patients. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs (including anaphylaxis), discontinue ERWINAZE and initiate appropriate therapy.

Pancreatitis
In clinical trials, 4% of patients reported pancreatitis with ERWINAZE therapy. Discontinue ERWINAZE for severe or hemorrhagic pancreatitis manifested by abdominal pain >72 hours and amylase elevation ≥2.0 x ULN. In case of mild pancreatitis, hold ERWINAZE until the signs and symptoms subside and amylase levels return to normal. After resolution, ERWINAZE therapy may be resumed.

Glucose Intolerance
In clinical trials, 5% of patients reported glucose intolerance, which in some cases may be irreversible. Monitor glucose levels at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.

Thrombosis and Hemorrhage
Serious thrombotic events, including sagittal sinus thrombosis, have been reported in both E. coli and Erwinia-derived L-asparaginase therapy. The following coagulation proteins were decreased in the majority of patients after a 2-week course of ERWINAZE by intramuscular administration: fibrinogen, protein C activity, protein S activity, and anti-thrombin III. Discontinue ERWINAZE for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, ERWINAZE therapy may be resumed.

Most Common Adverse Reactions
The most common adverse reactions (incidence 1% or greater) with ERWINAZE treatment are systemic hypersensitivity, hyperglycemia, transaminases abnormal, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, and diarrhea.

Please see full Prescribing Information.