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warnings
WARNINGS Zemaira ® may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Zemaira ® is contraindicated in patients with antibodies against IgA due to risk of severe hypersensitivity. Zemaira ® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Zemaira ® is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. (See DESCRIPTION section for viral reduction measures.) The manufacturing procedure for Zemaira ® includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. The primary viral reduction steps of the Zemaira ® manufacturing process are pasteurization (60°C for 10 hours) and nanofiltration. Additional purification procedures used in the manufacture of Zemaira ® also potentially provide viral reduction. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus, the risk of transmission of infectious agents can not be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958. The physician should discuss the risks and benefits of this product with the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections (see Information For Patients ). During clinical studies, no cases of hepatitis A, B, C, or HIV viral infections were reported with the use of Zemaira ® .
ADVERSE REACTIONS In clinical studies, the following adverse reactions considered treatment-related by the investigator were reported following intravenous administration of Zemaira ® , 60 mg/kg weekly: 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 ® and Prolastin ® . No clinically significant differences were detected between the two treatment groups. Table 3: Summary of Adverse Events Zemaira ® Prolastin ® No. of subjects treated 89 32 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 0 0 No. of infusions 1296 160 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 ® -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 Zemaira ® 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 ® treatment group, 7 subjects (23%) had a total of 11 exacerbations of their COPD.
adverse reactions table
<table width="80%" ID="table3"> <caption>Table 3: Summary of Adverse Events</caption> <col width="50%" align="left" valign="top"/> <col width="25%" align="center" valign="top"/> <col width="25%" align="center" valign="top"/> <thead> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">Zemaira<sup>®</sup> </th> <th styleCode="Rrule">Prolastin<sup>®</sup> </th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of subjects treated</td> <td styleCode="Rrule">89</td> <td styleCode="Rrule">32</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of subjects with adverse events regardless of causality (%)</td> <td styleCode="Rrule">69 (78%)</td> <td styleCode="Rrule">20 (63%)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of subjects with related adverse events (%)</td> <td styleCode="Rrule">5 (6%)</td> <td styleCode="Rrule">4 (13%)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of subjects with related serious adverse events</td> <td styleCode="Rrule">0</td> <td styleCode="Rrule">0</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of infusions</td> <td styleCode="Rrule">1296</td> <td styleCode="Rrule">160</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">No. of adverse events regardless of causality (rates per infusion)</td> <td styleCode="Rrule">298 (0.230)</td> <td styleCode="Rrule">83 (0.519)</td> </tr> <tr> <td styleCode="Lrule Rrule">No. of related adverse events (rates per infusion)</td> <td styleCode="Rrule">6 (0.005)</td> <td styleCode="Rrule">5 (0.031)</td> </tr> </tbody> </table>