May 31, 2016
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Erwinaze

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Erwinaze




Indications
Dosage
How Supplied

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

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

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

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 [see CLINICAL PHARMACOLOGY].

Preparation and Handling 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. 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 [See HOW SUPPLIED/Storage and Handling].

Administration Instructions

ERWINAZE solution can be administered by intramuscular injection or by intravenous infusion.

  • 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.

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: Jazz Pharmaceuticals, Inc., Palo Alto, CA 94304. Revised: Mar 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/13/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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