ZEMAIRA is proven to raise and maintain serum levels of alpha-1 antitrypsin (A1AT).20 Clinical data demonstrating the long-term effects of chronic augmentation therapy with ZEMAIRA are not available.
Dotted line represents the theoretical clinically protective threshold of 11 μM for alpha1 antitrypsin.
This figure shows the levels of A1AT following administration of ZEMAIRA to 30 patients with A1AT deficiency.20
ZEMAIRA was administered once a week for 24 weeks at a dose of 60 mg per kg of body weight
The dotted line represents an A1AT level of 11 µM, a threshold presumed to provide therapeutically relevant anti-neutrophil elastase protection
Patients treated with ZEMAIRA in this study demonstrated a rapid increase in serum A1AT levels that were maintained throughout the study period
The effect of augmentation therapy with ZEMAIRA or any A1-PI product on pulmonary exacerbations and on the progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical studies
A heritage of high-quality plasma manufacturing safety standards
CSL Behring has been fractionating human plasma for more than 60 years, employing an expert team of virologists and quality-assurance systems and controls that are among the most rigorous and powerful in the industry.
ZEMAIRA has been used for over 10 years with no confirmed cases of virus transmission.21 Like all CSL Behring products, the manufacturing and purification process is rigorous:
Initial donor testing and selection
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
While all efforts are made to prevent the transmission of infectious agents and viruses, the risk of transmission cannot be completely eliminated
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
The recommended dose of ZEMAIRA is 60 mg/kg body weight administered once weekly.
Low infusion volume
ZEMAIRA is supplied in a single-use vial containing approximately 1000 mg of functionally active A1-PI for reconstitution with 20 mL of sterile water.
A 165-pound patient will require approximately 90 mL of solution
ZEMAIRA is 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
For a 165-pound patient, infusion will take approximately 15 minutes (dosing is weight-based, so individual time of infusion will vary)
ZEMAIRA can be stored safely at room temperature
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Enter patient's weight:
Based on a weight of 0 lb/0 kg, the recommended dose of ZEMAIRA for your patient is:
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