CLINICAL DATA

Trusted therapy.

Demonstrated effects

Zemaira is proven to raise and maintain therapeutic levels of alpha-1 antitrypsin (A1AT).5  Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira are not available.

Efficacy

  • In clinical trials, Zemaira has been proven effective for chronic augmentation and maintenance therapy.
  • Zemaira was shown to produce a rapid increase in alpha-1 antitrypsin to therapeutic levels and to maintain those levels over 2 years of therapy.

Highly purified

  • Undergoes virus removal and inactivation steps to minimize the risk of virus transmission.
  • Manufactured in a state-of-the-art facility under stringent, controlled conditions.
    • The manufacturing process includes 2 virus clearance steps.
      • Heat treatment at 60°C for 10 hours.
      • Nanofiltration.
  • Zemaira has been in use for over 10 years with no confirmed reports of virus transmission.
    • While all efforts are made to prevent the transmission of infectious agents and viruses, the risk of transmission cannot be completely eliminated.

Safe

  • Studies have shown that A1AT augmentation therapy is safe. In clinical studies of Zemaira, at least 5% of subjects reported adverse reactions related to treatment, including headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.

DOSING AND ADMINISTRATION

Zemaira dosing

  • The recommended dose of Zemaira is 60 mg/kg body weight administered once weekly.
  • Low infusion volume.*

Administration

  • Can be stored safely at room temperature.
  • Easy to reconstitute.
  • Administered intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient.
  • The recommended dosage will take approximately 15 minutes to infuse.

*Averages are based on 75-kg patient, and individual experiences may vary.

Dosage calculator agreement

END USER LICENSE AGREEMENT FOR CSL BEHRING LLC ZEMAIRA DOSAGE CALCULATOR

This End User License Agreement ("Agreement") is a legal agreement between you and CSL Behring LLC ("CSL") regarding your use of the Zemaira Dosage Calculator ("Calculator"). This Agreement governs your use of this Calculator, including, without limitation, the use of all content such as text, information, and images and the suite of services, integrated tools, programs, software, databases, helpers, and other related items. By checking the "I have read and agree to these terms of use" checkbox, you accept to be bound by all the terms and conditions of this Agreement. If you do not accept the terms of this Agreement, you will not be able to use the Calculator. Your use of the Calculator is subject to the following terms and conditions of this Agreement.

  1. GRANT OF LICENSE. Subject to the terms of this Agreement, CSL hereby grants to you a limited, non-exclusive, non-transferable license to access and use the Calculator solely for your personal use. You may not rent, lease, sell, sublicense, assign, reverse engineer, disassemble, modify, loan, distribute, export or otherwise transfer, or allow others to use the Calculator, technology, or other information, including any printed materials of the same, nor may you create derivative works of or otherwise modify the same. This license will automatically terminate if you do not comply with the terms of this Agreement. You may not use, download, or export the Calculator in violation of any applicable laws or regulations.
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PRIVACY INFORMATION

CSL does not collect personal information about you when you use this Calculator. If you have any question regarding the use of your non-personal information resulting from your use of the Calculator, please contact us at cslwebapps@cslbehring.com.

Please agree to the end user license agreement before continuing

Please agree to the end user license agreement before continuing

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. No clinical data are available demonstrating the effect of augmentation therapy with Zemaira or any A1-PI product on the progression of emphysema in A1-PI deficiency.

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, 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.

Zemaira is manufactured and distributed by CSL Behring LLC.
Zemaira® is a registered trademark of CSL Behring LLC.

© 2017 CSL Behring LLC. The product information presented on this site is intended for US residents only. ZMR03-13-0022(3) 6/2015