CSL Behring Demonstrates Continued Commitment to Alpha-1 Community with Addition of ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)] 4- and 5-Gram Vials

02 Jan 2024
www.prnewswire.com
Drug Approval
-    4- and 5-gram ZEMAIRA® vials may reduce the number of vials necessary for reconstitution, thereby providing convenience and lowering package waste
KING OF PRUSSIA, Pa., Jan. 2, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)]. Previously available only in a 1-gram vial, the 4- and 5-gram packaging is significant for the Alpha-1 community as it will streamline the preparation process for ZEMAIRA and reduce waste.
ZEMAIRA dosing is weight-based, so a person weighing 183 pounds would require five 1-gram vials. With the 4- and 5-gram vial sizes, healthcare professionals will need to reconstitute fewer ZEMAIRA vials per dose for their patients with Alpha-1. Room temperature storage coupled with the larger vial sizes may also help streamline preparation and administration.
"We have been providing ZEMAIRA to the Alpha-1 community for 20 years and are committed to listening and addressing unmet needs through our therapies and patient programs," said Shannen Silvestrini, Director, ZEMAIRA Marketing, CSL Behring. "With the larger vial sizes, we will continue to provide a safe and effective treatment option while potentially making it easier for healthcare professionals to prepare ZEMAIRA for their patients."
Lowering the number of vials patients need also positively contributes to CSL's efforts to reduce waste in the supply chain and end-to-end production, which is an area of focus of the Environmental Pillar of CSL's Sustainability Strategy.
For more information on ZEMAIRA, please visit www.Zemaira.com.
About Alpha1 Antitrypsin Deficiency
Alpha1 Antitrypsin (AAT) Deficiency is a hereditary condition that can severely affect a patient's lung function. The condition is marked by a low level or absence of AAT, a natural protein that inhibits neutrophil elastase, thereby preventing destruction of lung tissue. Severe deficiency of AAT is associated with a strong tendency for the development of emphysema, a form of chronic obstructive pulmonary disease (COPD), and can significantly impact everyday life and life expectancy.
About ZEMAIRA®
ZEMAIRA is a highly purified form of AAT (human) currently approved in the US, Brazil, Mexico, and Puerto Rico, where it is indicated for chronic augmentation and maintenance therapy in adults with Alpha 1 Antitrypsin DeficiencyAlpha 1 Antitrypsin Deficiency and clinical evidence of emphysema. CSL Behring markets ZEMAIRA as Respreeza® in Europe.
Important Safety Information (ISI)
Alpha1-Proteinase Inhibitor (Human), ZEMAIRA® is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.
ZEMAIRA may not be suitable for everyone; for example, people with known hypersensitivity to components used to make ZEMAIRA, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.
Early signs of hypersensitivity reactions to ZEMAIRA include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.
In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving ZEMAIRA: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.
Because ZEMAIRA is made from human blood, the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
Please see
full prescribing information
for ZEMAIRA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring.
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