About ZEMAIRA

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About A1AT deficiency (AATD)

AATD is a hereditary condition characterized by low levels of a protein called alpha1 antitrypsin (A1AT). AATD results in uninhibited neutrophil elastase activity, an imbalance that can lead to progressive degenerative and destructive changes in the lungs, including emphysema.1

AATD can be challenging to diagnose because it shares an identical clinical presentation with more common conditions like chronic obstructive pulmonary disease (COPD) and asthma.1 AATD is the most common genetic risk factor for COPD.2 In fact, current guidelines recommend screening all individuals diagnosed with COPD or unexplained bronchiectasis for AATD regardless of age or ethnicity.3

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What is ZEMAIRA?

ZEMAIRA is an alpha1-proteinase inhibitor (A1-PI) indicated for chronic augmentation and maintenance therapy in adults with A1-PI deficiency and emphysema.

ZEMAIRA, a highly purified augmentation therapy, has been used in alpha1 treatment for more than 16 years with no confirmed cases of virus transmission.4

ZEMAIRA is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.

Please see full prescribing information for ZEMAIRA.
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What are the key benefits?

ZEMAIRA is a once-per-week infusion that is proven to elevate and maintain serum levels of A1AT.*

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Low infusion volumes allow for treatment in as little as 15 minutes.†
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ZEMAIRA can be stored safely at room temperature.

*Clinical data demonstrating the long-term effects of chronic augmentation therapy with ZEMAIRA are not available. The effect of augmentation therapy with ZEMAIRA or any A1-PI product on pulmonary exacerbations and the progression of emphysema in A1AT deficiency have not been demonstrated in randomized, controlled clinical studies.

†Average infusion time is based on an infusion rate of 0.08 mL/kg/min for a 75 kg (165 lb) patient. Individual experiences may vary.

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

Important Safety Information

Alpha1-Proteinase Inhibitor (Human), ZEMAIRA® is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. The effect of augmentation therapy with ZEMAIRA or any A1-PI product on pulmonary exacerbations and progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical studies.

ZEMAIRA is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.

ZEMAIRA is contraindicated in patients with a history of severe systemic reactions to the product or to A1-PI protein, including anaphylaxis. Due to the risk of severe hypersensitivity, ZEMAIRA is also contraindicated in immunoglobulin A-deficient patients with antibodies against IgA.

Use caution in administering ZEMAIRA to patients who have experienced anaphylaxis or severe systemic reactions to another A1-PI product. Patients with selective or severe IgA deficiency can develop antibodies to IgA and are at greater risk of such reactions. If anaphylactic or severe anaphylactoid reactions occur during infusion, discontinue immediately.

In pre-licensure clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving ZEMAIRA: headache, sinusitis, upper respiratory infection, bronchitis, asthenia, increased cough, fever, injection-site hemorrhage, rhinitis, sore throat, and vasodilation.

ZEMAIRA is derived from human plasma. The risk of transmission of 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.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Alpha-1 antitrypsin deficiency. National Organization for Rare Disorders (NORD). Accessed April 6, 2022. https://rarediseases.org/rare-diseases/alpha-1-antitrypsin-deficiency 2. Lung disease. Alpha-1 Foundation. Accessed April 6, 2022. https://www.alpha1.org/newly-diagnosed/learning-about-alpha-1/lung-disease 3. Sandhaus RA, Turino G, Brantly ML, et al. The diagnosis and management of alpha-1 antitrypsin deficiency in the adult. Chronic Obstr Pulm Dis. 2016;3(3):668-682. doi:10.15326/jcopdf.3.3.2015.0182 4. Data on file. Available from CSL Behring as DOF ZMR-002.

ZEMAIRA is manufactured and distributed by CSL Behring LLC.

Driven by Our Promise™ is a trademark and ZEMAIRA® is a registered trademark of CSL Behring LLC.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

ZMR-0074-OCT22

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