Alpha1-proteinase inhibitor(Grifols SA)

DALLAS--( BUSINESS WIRE )--AIC, a division of AIS Healthcare, now offers GLASSIA and ARALAST NP, manufactured by Takeda, for the treatment of adult patients with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI (alpha 1 -antitrypsin deficiency). The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or at an infusion suite setting. The addition of these therapy options expands AIC’s ability to better serve patients with alpha 1 -antitrypsin deficiency. “We’re excited and proud to be able to add Takeda’s Alpha 1 therapies to our growing portfolio of infusion therapies,” said Jud Hall, President at AIC. “The addition of GLASSIA and ARALAST NP can help us provide patients with more options to meet individual treatment needs.” Approved by the U.S. Food and Drug Administration (FDA) in 2010 and 2002, respectively, GLASSIA and ARALAST NP are Alpha 1 -Proteinase Inhibitors (Human) (Alpha 1 -PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI. ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha 1 -PI. The effect of augmentation therapy with GLASSIA, ARALAST NP, or any Alpha 1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha 1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA or ARALAST NP are not available. GLASSIA and ARALAST NP are not indicated as therapies for lung disease in patients in whom severe Alpha 1 -PI deficiency has not been established. Both GLASSIA and ARALAST NP are now available at all AIC locations (Valdosta, Georgia; Birmingham, Alabama; Panama City, Florida; Dallas, Texas). Like all AIC patients, those with alpha 1 -antitrypsin deficiency will receive a high level of care from AIC, including 24/7 access to clinical and support staff. Every patient is assigned a dedicated team of professionals, including clinical pharmacists, home infusion nurses, RN clinical review specialists and patient onboarding specialists to provide support throughout the treatment process. For providers, AIC is a full-service care delivery partner. We also work directly with patients, insurance companies, and provider offices to secure all needed insurance authorizations and approvals. AIC is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/ About AIS Healthcare Advancing quality. Improving lives. As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do. Learn more at aiscaregroup.com . About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com .

- 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 . 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 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 , or call 1-800-FDA-1088. You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958. About CSL Behring 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. Media Contact Etanjalie Ayala Mobile: +1 610 297 1069 Email: [email protected] SOURCE CSL Behring