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Erwinaze

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Erwinaze

INDICATIONS

ERWINAZE (asparaginase Erwinia chrysanthemi) 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.

DOSAGE AND ADMINISTRATION

Recommended Dose

To substitute for a dose of pegaspargase:

The recommended dose is 25,000 International Units/m² administered intramuscularly three times a week (Monday/Wednesday/Friday) for six doses for each planned dose of pegaspargase.

To substitute for a dose of native E. coli asparaginase:

The recommended dose is 25,000 International Units/m² administered intramuscularly for each scheduled dose of native E. coli asparaginase within a treatment.

Preparation Instructions

  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 International Units per mL. When reconstituted with 2 mL the resultant concentration is 5,000 International Units per 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. Discard the reconstituted solution 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. Do not freeze or refrigerate reconstituted solution and administer within 4 hours or discard. [see HOW SUPPLIED].

Administration Instructions

  1. Inject ERWINAZE solution intramuscularly.
  2. 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.
  3. If a partial vial is used, do not save or reuse the unused drug for later administration. Discard unused portions.

HOW SUPPLIED

Dosage Forms And Strengths

Lyophilized powder 10,000 International Units per vial

Storage And Handling

ERWINAZE is a sterile, white lyophilized powder supplied in a clear 3 mL glass vial. Each carton of ERWINAZE (NDC 57902-249-05) contains 5 vials. Each single vial (NDC 57902-249-01) contains 10,000 International Units asparaginase Erwinia chrysanthemi.

Store unused or unopened vials and cartons at 36°F to 46°F (2°C to 8°C). Protect from light. Do not use ERWINAZE after the expiration date on the vial.

Manufactured by EUSA Pharma (USA), Inc. Langhorne, PA 19047. Revised: March 2014

Last reviewed on RxList: 3/21/2014
This monograph has been modified to include the generic and brand name in many instances.

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