Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Serious skin and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Neuropsychiatric events [see Warnings and Precautions (5.2) ] Most common adverse reaction (incidence >2%) is diarrhea.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc.
at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 5 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 <1% discontinued study because of an adverse reaction.
Clinically significant laboratory abnormalities (DAIDS Grades 2 to 4) listed in Table 4 occurred more frequently in subjects treated with RAPIVAB 600 mg (intravenous or intramuscular) than placebo.
Only events occurring at ≥2% are included.
Table 4: Laboratory Abnormalities Occurring in ≥2% of Subjects Treated with RAPIVAB 600 mg Laboratory Parameter Abnormality a RAPIVAB 600 mg Placebo a Frequencies based on treatment-emergent laboratory abnormalities.
Alanine Aminotransferase (>2.5 × ULN) (n = 654) 3% (n = 430) 2% Serum Glucose (>160 mg/dL) (n = 660) 5% (n = 433) 3% Creatine Phosphokinase (≥6.0 × ULN) (n = 654) 4% (n = 431) 2% Neutrophils (<1.000 ×10 9 /L) (n = 654) 8% (n = 430) 6% 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%).
5 WARNINGS AND PRECAUTIONS Cases of anaphylaxis and serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB.
Discontinue RAPIVAB and initiate appropriate treatment if anaphylaxis or serious skin reaction occurs or is suspected.
( 5.1 ) Neuropsychiatric events: Patients with influenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness.
Monitor for signs of abnormal behavior.
( 5.2) 5.1 Serious Skin/Hypersensitivity Reactions Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience.
Like all medications, Rapivab can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: