TRUSTED ALPHA-1 THERAPY

Zemaira effectively raises the plasma level of A1PI.

Zemaira is:

  • Approved by the FDA to raise the plasma level of alpha-1 proteinase inhibitor (A1PI) in patients with A1AT deficiency and related emphysema.
  • A highly purified Alpha-1 protein derived from human plasma.
  • Safe, with few and generally mild side effects.
  • A drug with low infusion volume that requires about 15 minutes to infuse.*

*Averages based on 75-kg patient (approximately 165 pounds); individual experiences may vary.

If at any time you have questions about your treatment, we urge you to talk to your doctor.

Efficacious

  • Zemaira is proven in clinical trials to raise and maintain therapeutic levels of alpha-1 antitrypsin.5
  • Zemaira was shown to produce and maintain therapeutic levels of alpha-1 antitrypsin levels.
  • Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira are not available.

Highly purified

  • Zemaira is a highly purified product made from human blood and undergoes virus removal and inactivation.
  • Zemaira is made in a state-of-the-art facility under stringent, controlled conditions.
    • The 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, 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.
  • Your doctor will advise you if Zemaira is right for you.

Once-weekly administration.
Low, weight-based infusion volume.

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.
  • Administration rate as determined by the response and comfort of the patient.
  • For a 165-pound patient, infusion will take approximately
    15 minutes (dosing is weight-based, so individual time of infusion will vary).

Important Safety Information

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, 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® and CareZ® are registered trademarks of CSL Behring LLC.

© 2015 CSL Behring LLC. The product information presented on this site is intended for US residents only. ZMR03-13-0022(2) 12/2014