PharmacovigilanceOfficial

AIFA publishes DHPC on Respreeza vial closure defects affecting specific batches

🇮🇹 AIFA · Wed 04 Nov 2026

CSL Behring has reported stopper defects in certain Respreeza batches that could prevent administration or allow microbial contamination, prompting a quality-related communication to healthcare professionals.

Italy's medicines agency AIFA published on 4 November 2026 a Direct Healthcare Professional Communication on a quality issue with Respreeza (alpha1-proteinase inhibitor (human)). The notice warns of a risk of missed doses and potential infection arising from compromised vial integrity.

According to the communication, CSL Behring received reports of container closure defects affecting specific Respreeza batches, which are listed in Table 1 in the 'Context' section of the DHPC. In the reported cases, parts of the vial stopper loosened or detached when the Mix2Vial transfer device was removed from the vial after reconstitution.

The defects occurred even though the product had been prepared and handled in line with the instructions for use. As a result, the reconstituted product may be impossible to administer, leading to missed or delayed doses. If the vial is no longer properly sealed, there is also a risk of microbial contamination that could cause serious infection.

If the defect appears during reconstitution as described in the product information, the product must not be administered and a product complaint should be reported. The defective vial and the transfer device should be kept and sent to CSL Behring for investigation, and patients will be given replacement product.

Patients who use Respreeza at home should be told by their treating physician or dispensing pharmacy that compromised vial integrity can make administration impossible. They should also be told that the risk of potential infection cannot be ruled out if product from an affected vial is given.

What it means for your team

  • Check stock and patient supplies against the batch list in Table 1 of the DHPC.
  • Make sure clinicians and pharmacies know not to administer product if the stopper defect appears during reconstitution, and that a complaint must be filed.
  • Retain defective vials and Mix2Vial devices for return to CSL Behring, and arrange replacement supply to avoid treatment interruption.
  • PV and QA teams should ensure home-treatment patients are informed and that any related complaints or adverse events are captured.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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