Respreeza (alpha1-proteinase inhibitor (human)): risk of missed dose and potential infection due to compromised vial integrity.

Summary:

• CSL Behring has received reports of container closure defects affecting specific batches of Respreeza.  The affected batches are listed in Table 1 in the Background section.  
• In the reported cases, when the Mix2Vial transfer device was removed from the product vial after reconstitution, parts of the vial closure became loose or detached which compromised the integrity of the vial. The defects occurred despite the product being prepared and handled in accordance with the instructions for use.  
• As a result of these defects, it may not be possible to administer the reconstituted product, resulting in missed or delayed doses. If the vial is no longer properly sealed, there is also a risk of microbial contamination which could lead to a serious infection. 
• If this defect occurs during the reconstitution process as described in the product information, the product should not be administered, and a product complaint should be reported. The defective product vial and transfer device should be retained and submitted to CSL Behring for investigation. Patients will receive replacement products.   
• Patients receiving Respreeza® in the home setting should be informed by their treating physician or dispensing pharmacy that compromised vial integrity may result in inability to administer the product and that risk of potential infection cannot be excluded if product from an affected vial is administered.