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Intravenous administration of Zemaira (alpha-proteinase inhibitor (human)) , 60 mg/kg weekly, has been shown to be generally well tolerated. In clinical studies, the following treatment-related adverse reactions were reported: asthenia, injection site pain, dizziness, headache, paresthesia, and pruritus. Each of these related adverse events was observed in 1 of 89 subjects (1%). The adverse reactions were mild.

Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate countermeasures and supportive therapy should be administered.

Table 3 summarizes the adverse event data obtained with single and multiple doses during clinical trials with Zemaira (alpha-proteinase inhibitor (human)) and Prolastin®. No clinically significant differences were detected between the two treatment groups.

Table 3: Summary of Adverse Events




No. of subjects treated



No. of subjects with adverse events regardless of causality (%)

69 (78%)

20 (63%)

No. of subjects with related adverse events (%)

5 (6%)

4 (13%)

No. of subjects with related serious adverse events



No. of infusions



No. of adverse events regardless of causality (rates per infusion)

298 (0.230)

83 (0.519)

No. of related adverse events (rates per infusion)

6 (0.005)

5 (0.031)

The frequencies of adverse events per infusion that were ≥0.4% in Zemaira (alpha-proteinase inhibitor (human)) -treated subjects, regardless of causality, were: headache (33 events per 1296 infusions, 2.5%), upper respiratory infection (1.6%), sinusitis (1.5%), injection site hemorrhage (0.9%), sore throat (0.9%), bronchitis (0.8%), asthenia (0.6%), fever (0.6%), pain (0.5%), rhinitis (0.5%), bronchospasm (0.5%), chest pain (0.5%), increased cough (0.4%), rash (0.4%), and infection (0.4%). The following adverse events, regardless of causality, occurred at a rate of 0.2% to <0.4% per infusion: abdominal pain, diarrhea, dizziness, ecchymosis, myalgia, pruritus, vasodilation, accidental injury, back pain, dyspepsia, dyspnea, hemorrhage, injection site reaction, lung disorder, migraine, nausea, and paresthesia.

Diffuse interstitial lung disease was noted on a routine chest x-ray of one subject at Week 24. Causality could not be determined.

In a retrospective analysis, during the 10-week blinded portion of the 24-week clinical study, 6 subjects (20%) of the 30 treated with Alpha1-Proteinase Inhibitor (Human), Zemaira (alpha-proteinase inhibitor (human)) had a total of 7 exacerbations of their chronic obstructive pulmonary disease (COPD). Nine subjects (64%) of the 14 treated with Prolastin® had a total of 11 exacerbations of their COPD. The observed difference between groups was 44% (95% confidence interval from 8% to 70%). Over the entire 24-week treatment period, of the 30 subjects in the Zemaira (alpha-proteinase inhibitor (human)) treatment group, 7 subjects (23%) had a total of 11 exacerbations of their COPD.