Zemaira Side Effects
Please note - some side effects for Zemaira may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Zemaira - for the Consumer
Zemaira
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zemaira:
Seek medical attention right away if any of these SEVERE side effects occur when using Zemaira:Dizziness; headache; pain, swelling, or redness at injection site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); swelling of the ankles or feet; symptoms of infection (eg, fever, chills, muscle aches, sore throat); tingling or numbness of the skin; weakness.
Zemaira Side Effects - for the Professional
Zemaira
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.
| 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.
TopSide Effects by Body System
Respiratory
Respiratory side effects have included chest pain, pharyngitis, asthma, rhinitis, bronchitis, sinusitis, cough, upper and lower respiratory tract infections, viral infections, and dyspnea.
Nervous system
Nervous system side effects have included dizziness, headache, and somnolence.
Cardiovascular
Cardiovascular side effects have included peripheral edema, bloating, and vasodilation.
Ocular
Ocular side effects have included abnormal vision.
Hepatic
Hepatic side effects have included elevations (> two times the upper normal limit) in aminotransferases (ALT or AST).
General
General side effects have included chills and fever.
Dermatologic
Dermatologic side effects have included pruritus and rash.
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