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First-and-only ONE-DOSE IV treatment for influenza1

Indicated for the treatment of acute, uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.

  • 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 enrolled1
  • Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use1
  • Efficacy could not be established in patients with serious influenza requiring hospitalization3

 

Significantly shortens time to symptom alleviation and fever reduction in the treatment of acute seasonal influenza1

RapivabArtwork_alleviationchartsidebysidestacked2
RapivabArtwork_alleviationchartsidebysidestacked1

Results are from a randomized, double-blind, placebo-controlled trial in subjects 20 to 65 years of age with acute uncomplicated influenza. Eligible subjects had fever greater than 38°C (axillary) and a positive rapid antigen test for influenza virus, accompanied by at least two symptoms (cough, nasal symptoms, sore throat, myalgia, chills/sweats, fatigue, or headache). Study treatment was started within 48 hours of onset of symptoms, with the majority of subjects (53%) starting treatment within 24 hours of symptom onset. All subjects enrolled were also allowed to take fever-reducing medications. The study was well-balanced for baseline demographic and virologic parameters, with the majority infected with influenza A/H1N1 subtype. Subjects participating in the trial were required to self-assess their influenza symptoms as ‘none’, ‘mild’, ‘moderate’, or ‘severe’ twice daily. The primary endpoint, time to alleviation of symptoms, was defined as the number of hours from initiation of study drug until the start of the 24-hour period in which all seven symptoms of influenza (cough, sore throat, nasal congestion, headache, feverishness, myalgia, and fatigue) were either absent or present at a level no greater than mild for at least 21.5 hours.1,3

Rapivab delivers the safety and efficacy you need to treat influenza immediately in a single dose1,3

  • Reduced median time to alleviation of symptoms by 21 hrs (p<0.005) (81 vs 60 hours) vs. placebo
  • Reduced median time to resolution of fever by 12 hrs vs placebo (p<0.005) (42 vs 30 hours)
  • Showed consistent benefit, independent of age, gender, race, region, smoking status, influenza virus subtype and severity of illness
  • The efficacy of Rapivab could not be established in patients with serious influenza requiring hospitalization3

Active against influenza A and B viruses1

  • Exhibits broad-spectrum in vitro activity against influenza subtypes, including: H1N1, H3N2, H5N14, and H7N95
  • Binds tightly to influenza virus neuraminidase and prevents the release of virus from infected cells
  • 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

Immediately bioavailable with confirmed adherence1

  • Delivered in its active form directly to the blood stream
  • Not significantly metabolized
  • Only requires a single dose in acute, uncomplicated influenza

Safety profile similar to placebo1

  • Most common adverse reaction is diarrhea (8% vs 7% for placebo)
  • Safe for use in patients with renal dysfunction with dose adjustment (See Dosage and Administration)
  • No contraindications and no known drug-drug interactions
  • Avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated

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% vs 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

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% vs 2%), insomnia (3% vs 0%), AST increased (3% vs 2%), and hypertension (2% vs 0%).

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