The following adverse reactions are discussed in other sections of the labeling:
- Serious skin and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Neuropsychiatric Events [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In five randomized, double-blind, controlled trials, 1,399 subjects with acute uncomplicated influenza received a single dose of RAPIVAB, administered intravenously or intramuscularly, at doses up to 600 mg. Among the 664 subjects receiving RAPIVAB 600 mg (intravenous or intramuscular), the most commonly observed adverse reaction was diarrhea, occurring at a rate of 8% versus 7% in subjects receiving placebo. No subject receiving RAPIVAB 600 mg experienced a serious adverse event and less than 1% discontinued study because of an adverse reaction.
Clinically significant laboratory abnormalities (DAIDS Grade 2-4) listed in Table 2 occurred more frequently in subjects treated with RAPIVAB 600 mg (intravenous or intramuscular) than placebo. Only events occurring at ≥ 2% are included.
Table 2: Laboratory Abnormalities Occurring in ≥ 2% of Subjects Treated with RAPIVAB 600 mg
|Laboratory Parameter Abnormalitya||RAPIVAB 600 mg||Placebo|
|Alanine Aminotransferase ( > 2.5 x ULN)||(N=654) 3%||(N=430) 2%|
|Serum Glucose ( > 160 mg/dL)||(N=660) 5%||(N=433) 3%|
|Creatine Phosphokinase ( ≥ 6.0 x ULN)||(N=654) 4%||(N=431) 2%|
|Neutrophils ( < 1.000 x109/L)||(N=654) 8%||(N=430) 6%|
|a Frequencies based on treatment-emergent laboratory abnormalities|
In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101) the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).
The following additional adverse reactions have been identified during postapproval use of RAPIVAB in Japan. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: Stevens-Johnson Syndrome, exfoliative dermatitis, rash [see WARNINGS AND PRECAUTIONS]
Psychiatric: abnormal behavior, hallucination [see WARNINGS AND PRECAUTIONS]