RAPIVAB SIDE EFFECTS
SIDE EFFECTS
The following adverse reactions are discussed in other sections of the labeling:
- Serious skin and hypersensitivity reactions
- Neuropsychiatric Events
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.
Adverse Reactions In Adults (18 years of age and older)
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 1 occurred more frequently in subjects treated with RAPIVAB 600 mg (intravenous or intramuscular) than placebo. Only events occurring at ≥2% are included.
Table 1: Laboratory Abnormalities Occurring in ≥2% of Subjects Treated with RAPIVAB 600 mg
| Laboratory Parameter Abnormality* | RAPIVAB 600 mg | Placebo |
| Alanine Aminotransferase (>2.5 x ULN) | (N=654) | (N=430) |
| 3% | 2% | |
| Serum Glucose (>160 mg/dL) | (N=660) | (N=433) |
| 5% | 3% | |
| Creatine Phosphokinase (≥6.0 x ULN) | (N=654) | (N=431) |
| 4% | 2% | |
| Neutrophils (<1.000 x109/L) | (N=654) | (N=430) |
| 8% | 6% | |
| * 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%).
Adverse Reactions In Adolescent And Pediatric Subjects (2 To 17 Years Of Age)
Assessment of adverse reactions is based on a randomized, active-controlled study in which 110 adolescent and pediatric subjects ages 2 to 17 years of age with acute uncomplicated influenza received open-label treatment with a single dose of RAPIVAB (N=88), or 5 days of treatment with oseltamivir (N=22).
The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults included vomiting (3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, respectively, for each of these events). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).
Postmarketing Experience
The following additional adverse reactions have been identified during postapproval use of RAPIVAB. 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
General disorders and administration site conditions: anaphylactic/anaphylactoid reactions
Psychiatric: abnormal behavior, hallucination
SRC: NLM .