Subject:ERWINAZE®(asparaginase Erwinia chrysanthemi) Batch 196K Notice of *New* Special Handling Instructions
Use a 0.2-micron, low protein binding, in-line filter for IV administration of
ERWINAZE® (asparaginase Erwinia chrysanthemi) from BATCH 196K.
Dear Health Care Provider:
The purpose of this letter is to alert you to Special Handling Instructions for ERWINAZE Batch 196K. During routine visual inspection of Batch 196K, particulate matter was observed in some vials. These vials were set aside and not released. However, some of the released vials may still contain particulate matter which, if present in reconstituted ERWINAZE, may pose a safety risk to patients. For this reason, in an effort to prevent the administration of particulate matter that may be found in some of the product after reconstitution, released vials of batch 196K require Special Handling Instructions as described in this letter. Because of the critical necessity for this drug, Jazz Pharmaceuticals is releasing these vials and asking health care providers to take these necessary steps for patient safety when using the product.
Healthcare professionals should adhere to the following in order to minimize the potential risk of adverse events from particulate matter:
Follow all recommended steps for reconstitution of ERWINAZE in accordance with the Updated Instructions for Preparation, below.
Carefully inspect each vial. If you observe particulate matter anywhere other than on the underside of the stopper (pre- or post-reconstitution), do not administer the product to the patient, quarantine the vial, and contact Jazz Pharmaceuticals Medical Information at 1‐800‐520‐5568 to report the issue and to discuss next steps.
If no visible particulate matter is observed in the reconstituted product, use a standard 5‐micron filter needle to withdraw the reconstituted ERWINAZE product from the vial. See filter needle manufacturer’s instructions or usage guidelines for proper use of filter needle.
ERWINAZE from Batch 196K may be administered either intramuscularly (IM) or intravenously (IV).
Both IM and IV administration require replacing the filter needle with a needle appropriate for administration to the patient.
For IV administration, also use a 0.2‐micron, low protein binding, in-line filter when administering the final IV mixture to patient.
Please ensure that your staff and any provider in your institution who may be involved in the reconstitution and administration of ERWINAZE receive a copy of this letter and specifically reviews the Updated Instructions for Preparations contained herein. Pay special attention to Steps 1 to 5 below.
UPDATED INSTRUCTIONS FOR PREPARATION: ERWINAZE Batch 196K Vial
Preparation and Handling Instructions
Step 1. Inspect the Product Prior to Reconstitution.
Carefully inspect each vial before use.
If you observe particulate matter, anywhere other than on the underside of the stopper (pre- or post-reconstitution), do not administer to the patient, quarantine the vial, and contact Jazz Pharmaceuticals Medical Information at 1 800-520-5568 to report the issue and discuss next steps.
Step 2. Reconstitute.
If you do not observe particulate matter, 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. Do not forcefully inject the solution for reconstitution directly onto or into the powder.
Dissolve contents by gentle mixing or swirling. Do not shake or invert vial.
Inspect the solution after reconstitution for any visible particles or protein aggregates. When reconstituted, ERWINAZE should be a clear, colorless solution. If you observe particulate matter in the reconstituted product, do not administer to the patient; follow the instructions regarding quarantining the vial in Step 1(ii) above.
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.
Step 3. Calculate the Dose and Withdraw the Volume Needed.
Confirm the calculation for the dose of ERWINAZE requested.
Calculate the volume of reconstituted product needed to obtain the requested dose.
Withdraw the volume containing the calculated dose from the vial using a 5-micron filter needle* into a polypropylene syringe within 15 minutes of reconstitution.
*Note: See filter needle manufacturer’s instructions or usage guidelines for proper use of filter needle.
ERWINAZE solution may be administered by either intramuscular (IM) injection or intravenous (IV) infusion.
Step 4a. For IM Administration.
Discard the filter needle and, for IM administration, replace with an appropriate needle prior to IM administration.
For IM administration, 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.
Step 4b. For IV Administration.
Discard the filter needle, replace with an appropriate needle, and transfer the reconstituted product to an IV infusion bag by slowly injecting 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.
For IV administration, also use a 0.2‐micron, low protein binding, in-line filter* when administering the final IV admixture to patient. Infuse ERWINAZE over 1 to 2 hours. Do not infuse other intravenous drugs through the same intravenous line while infusing.
*Note: Testing performed with a Baxter IV tubing extension set with 0.2 micron filter (Baxter Catalog ID: 2C8671) demonstrated no impact to ERWINAZE product quality.
Step 5. Storage and Handling.
If a partial vial is used, do not save or reuse the unused drug for later administration. Discard unused portions.
Do not freeze or refrigerate reconstituted solution and administer within 4 hours or discard [see Prescribing Information - How Supplied/Storage and Handling (16)].
The following label, attached to the carton, can identify vials from ERWINAZE Batch 196K:
REQUIRES 5-MICRON FILTER NEEDLE
IV ADMINISTRATION REQUIRES THE ADDITIONAL USE OF A 0.2-MICRON, LOW PROTEIN BINDING, IN-LINE FILTER
SEE INCLUDED IMPORTANT DRUG INFORMATION LETTER
Vials from ERWINAZE Batch 196K can also be identified by numbering on the individual vial labels. Vials from the affected batch will have one of the following lot numbers: 196K120, 196K220, 196K320, 196K420 or 196K520.
Please see accompanying Full Prescribing Information for ERWINAZE.
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Executive Director, Medical Affairs, Oncology
Jazz Pharmaceuticals, Inc.
If you have any questions, please call Jazz Customer Support at 650-496-3777
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