About ZemairaWhat is Alpha-1?Patient SupportPatient SupportFor Healthcare ProfessionalsPrescribing InformationImportant Safety InformationAlready Treating Your Alpha-1?Newly diagnosed with alpha-1?What is Augmentation Therapy?Diagnosed with Chronic Lung Disease?Receive Zemaira at no charge for up to 2 weeks.

What is Augmentation Therapy?

For Alpha-1 patients with emphysema, augmentation therapy with a form of
alpha1-proteinase inhibitor (A1-PI) derived from human plasma has been shown to help to increase the level of A1-PI in the lungs.1 This is important because studies show that low levels of A1-PI put you at risk of developing progressively worsening emphysema.1

Alpha-1 augmentation therapy is administered intravenously.1 It can be administered in a doctor's office, in an infusion center or hospital, or at home.2 The most common side effects of Alpha-1 augmentation therapy are fatigue, injection-site pain, dizziness, headache, tingling, and itching.

Zemaira® is used for chronic A1-PI augmentation therapy in adult Alpha-1 patients with emphysema. Zemaira® has been shown to be safe and effective, with half or less the infusion volume and time of other Alpha-1 therapies.3-5*

 
*Based on recommended dosage as stated in the product package inserts of 60 mg/kg body weight at the infusion rate of 0.08 mL/kg/min.

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. Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira are not available.

Zemaira may not be appropriate for the following adult individuals as they may experience severe reactions, including anaphylaxis: individuals with a known hypersensitivity and/or history of anaphylaxis or severe systemic reaction to A1-PI products or their components, and individuals with selective IgA deficiencies who have known antibodies against IgA.

In clinical studies, the following treatment-related adverse reactions were reported in 1% of subjects: asthenia (fatigue), injection-site pain, dizziness, headache, paresthesia (tingling), and pruritus (itching).

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.

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.

  1. American Thoracic Society/European Respiratory Society Task Force. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168:818-900.
  2. Alpha-1 Foundation. A Healthcare Provider’s Guide to Alpha-1 Antitrypsin Deficiency. [Alpha-1 Foundation Web Site], November 2003. Available at: http://www.alphaone.org/files/Healthcare_Providers_Guide.pdf. Accessed January 20, 2004.
  3. Data on file, CSL Behring LLC.
  4. Prolastin® Alpha1-Proteinase Inhibitor (Human), Full Prescribing Information, March 2003.
  5. Aralast™ Alpha1-Proteinase Inhibitor (Human), Full Prescribing Information, January 2003.