The Food and Drug Administration (FDA) has approved additional vial sizes of Zemaira (alpha1-proteinase inhibitor [human]; CSL Behring).
Zemaira is indicated for chronic augmentation and maintenance therapy in adults with A1-PI deficiency and clinical evidence of emphysema. In addition to the 1g vial, the product is now available in 4g and 5g vials. As the treatment is dosed by weight, introducing larger vial sizes reduces the number needed for reconstitution.
“Many Alpha 1 patients already experience the burden of weekly infusions,” said Dr Robert Sandhaus, MD, PhD, FCCP, Clinical Director, Alpha 1 Foundation and Medical Director, AlphaNet. “These larger vial sizes of Zemaira are an improvement that could make it much easier for patients by simplifying the steps necessary for preparation of their therapy.”
A1-PI deficiency is a chronic, hereditary, autosomal, co-dominant disorder that is usually fatal in its severe form. Low blood levels of A1-PI (i.e., below 11µM) are most commonly associated with progressive, severe emphysema that becomes clinically apparent by the third to fourth decade of life.
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