ADVERSE REACTIONS
Intravenous administration of Zemaira, 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 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.
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REPORTS OF SUSPECTED ZEMAIRA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Zemaira. The information is not vetted and should not be considered as verified clinical evidence.
Possible Zemaira side effects / adverse reactions in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-05
Patient: 64 year old male
Reactions: Dyspnoea, Respiratory Failure
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Zemaira
Possible Zemaira side effects / adverse reactions in 45 year old female
Reported by a pharmacist from United States on 2011-10-06
Patient: 45 year old female weighing 138.0 kg (303.6 pounds)
Reactions: Fatigue, Dyspnoea, Pain, Pulmonary Congestion, Insomnia, Oropharyngeal Pain, Pyrexia
Adverse event resulted in: hospitalization
Suspect drug(s):
Zemaira
Dosage: (60 mg/kg 1x/week, infused at a rate of 0.08 ml/kg/min (4.7 ml/min) intravenous
Indication: Alpha-1 Anti-Trypsin Increased
Start date: 2011-09-22
Zemaira
Dosage: (60 mg/kg 1x/week, infused at a rate of 0.08 ml/kg/min (4.7 ml/min) intravenous
Indication: Alpha-1 Anti-Trypsin Increased
Start date: 2011-05-24
Other drugs received by patient: Allegra; Prozac; Multivitamin (Daily Multivitamin); Doxepin HCL; Combivent; Symbicort; Valium; Sodium Chloride 0.9%; Xanaflex (Tizanidine)
Possible Zemaira side effects / adverse reactions in 49 year old female
Reported by a pharmacist from United States on 2011-10-13
Patient: 49 year old female weighing 60.8 kg (133.7 pounds)
Reactions: Urinary Tract Infection
Suspect drug(s):
Zemaira
Other drugs received by patient: Alendronate Sodium; Uniphyl; Symbicort; Calcium with D (Calcium with Vitamin D); Promethazine; Albuterol; Ipratropium BR (Ipratropium); Amitriptyline HCL; Vitamin D; Spiriva; Ferrous Sulfate TAB
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