CSL Behring announcement on their product Zemaira
Today, the Alpha-1 Foundation received the following communication from CSL Behring, regarding Zemaira®, their prescription drug for augmentation therapy for the treatment of Alpha-1 Antitrypsin Deficiency (Alpha-1):
“CSL Behring would like to inform you of a precautionary distribution hold of ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)], limited to CSL Behring warehouses, while we conduct an ongoing manufacturing investigation into the diluent packaged within this product. We sincerely regret this interruption and are working hard to improve the situation.
“We encourage patients to contact their pharmacy regarding their individual prescription and, if necessary, contact their physician about their treatment plan.
“This hold affects product at CSL Behring warehouses only. Based on analysis of reported adverse event data from the company’s global safety database, there is no indication of a patient safety concern related to the current product on the market. You can continue to use the product in your inventory.
“All CSL controlled inventory is on hold. CSL in Australia has communicated to all HCPs, nurses and pharmacist who have patients.
“Our commitment to patient care continues to be a key priority and guiding principle for CSL Behring, and it is our goal to manage supply so that patients experience minimal disruption. CSL Behring acknowledges the concern and hardships this presents for patients and physicians and will keep the community apprised of the situation so that therapy management decisions can be made from an informed position.”
As this is a manufacturing investigation into the diluent packaged with their product Zemaira®, CSL Behring is not issuing a recall and you can continue to use their product. A “diluent,” as referred to, is by definition a substance used to dilute something or a diluting agent (as the vehicle in a medicinal preparation).
According to the label on CSL Behring’s Zemaira®: ZEMAIRA is supplied in a single-use vial containing approximately 1000 mg, 4000 mg, or 5000 mg of functionally active A1 -PI as a white to off-white lyophilized powder for reconstitution with 20 mL, 76 mL, or 95 mL of Sterile Water for Injection, USP. The amount of functional A1 -PI is printed on the vial label and carton (3).
CSL Behring is reporting that this should not affect the distribution of their product Zemaira®.
For further clarity, other countries are not affected.
Source: Alpha-1 Foundation