1 INDICATIONS AND USAGE RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.

RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than two days.

( 1 ) Limitations of Use : Efficacy based on clinical trials in which the predominant influenza virus type was influenza A; a limited number of subjects infected with influenza B virus were enrolled.

( 1 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.

( 1 ) Efficacy could not be established in patients with serious influenza requiring hospitalization.

( 1 ) Limitations of Use : Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.

Influenza viruses change over time.

Emergence of resistance substitutions could decrease drug effectiveness.

Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs.

Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4) ].

The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.3) ].

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%).

Adverse Reactions in Adolescent and Pediatric Subjects (6 months to 17 years of age) Assessment of adverse reactions is based on a randomized, active-controlled study in which 130 adolescent and pediatric subjects ages 6 months to 17 years of age with acute uncomplicated influenza received open-label treatment with a single dose of RAPIVAB (n = 107), or 5 days of treatment with oseltamivir (n = 23) [see Use in Specific Populations (8.4) , Clinical Studies (14.2) ] .

The safety profile of RAPIVAB in subjects 6 months to 17 years of age was generally similar to that observed in adults.

The only adverse reaction reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults was vomiting (3% versus 9% for oseltamivir).

The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB (and not previously reported in adults) was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).

6.2 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 [see Warnings and Precautions (5.1) ] .

General Disorders and Administration Site Conditions: Anaphylactic/anaphylactoid reactions [see Warnings and Precautions (5.1) ] .

Psychiatric: Abnormal behavior, hallucination [see Warnings and Precautions (5.2) ] .