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Rapivab Clinical
Evidence in
Adults


Proven clinical results of Rapivab® (peramivir injection) in influenza treatment

In a clinical trial of adult patients aged 20 to 64, Rapivab was proven to shorten the amount of time that patients experienced symptoms of influenza.1

It offers a demonstrated safety profile in over 600 patients in clinical studies.1,2 Worldwide, over 1 million patients have received Rapivab.3

Rapivab is indicated for the treatment of acute, uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.1

Rapivab shortened time to alleviation of flu symptoms by 21 hours in adults1

  • Clinical Study Design

    Study design in adult patient population

    Efficacy was established in a randomized, double-blind, placebo-controlled trial involving previously healthy adults aged 20 to 64 years who reported onset of influenza-like illness within the previous 48 hours. Subjects were randomized to receive a single intravenous (IV) dose of Rapivab 300 mg (n = 99), Rapivab 600 mg (n = 97), or placebo (n = 100).1

    Eligible subjects had fever ≥38°C (axillary), a positive rapid antigen test for influenza virus, and at least 2 of the following: cough, nasal congestion, sore throat, myalgia, feverishness, fatigue, or headache. The study was well balanced for baseline demographic and virologic parameters, and the predominant influenza virus strain was the A/H1 subtype.1

    Rapivab significantly reduced the time to alleviation of symptoms compared with placebo.1 Overall, subjects receiving Rapivab 600 mg experienced alleviation of their combined influenza symptoms a median of 21 hours sooner than those receiving placebo. The median time to recovery to normal temperature (<37°C) was approximately 12 hours sooner compared with placebo.2 Recipients of Rapivab 300 mg experienced alleviation of symptoms in 59.1 hours (50.9-72.4; P = 0.0092). Recipients of Rapivab 600 mg experienced alleviation of symptoms in 59.9 hours (54.4-68.1; P = 0.0092).1

    Recipients of Rapivab reported shorter times to return to usual activities (43.6 h and 41.7 h earlier in the 300- and 600-mg groups, respectively; 300 mg, median duration 125.6 h [95% CI, 103.8-148.5; P = 0.0367]; 600 mg, 127.4 h [95% CI, 122.1-153.1; P = 0.0152]; and placebo, 169.1 h [95% CI, 142.0-180.0]).1

    Rapivab reduced time to resolution of fever by 12 hours in adults2,4,a

    Rapivab offers the potential for patients to return to normal function nearly 2 days sooner than those who did not receive an antiviral.1

    Rapivab has a demonstrated safety profile in adults

    In clinical trials, diarrhea was the most commonly occurring adverse reaction in patients receiving Rapivab 600 mg (n = 664).2

    No subject receiving Rapivab 600 mg experienced a serious adverse event, and <1% discontinued the study because of an adverse reaction.2

    Rapivab has been used in more than 1,000,000 patients.3

  • Safety Trial Design

    Study description in adult patient population

    In 5 randomized, double-blind, controlled trials, 1399 subjects with acute uncomplicated influenza received a single dose of Rapivab, intravenous (IV) or intramuscular (IM) administration, at doses up to 600 mg. Among the 664 subjects receiving Rapivab 600 mg (IV or IM), the most commonly observed adverse reaction was diarrhea, which occurred at a rate of 8% versus 7% in subjects receiving placebo.2

References: 1. Kohno S, Kida H, Mizuguchi M, Shimada J; S-021812 Clinical Study Group. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother. 2010;54(11):4568-4574. 2. Rapivab [package insert]. Summit, NJ: Seqirus USA Inc; 2017. 3. bioCSL. Development safety update report #5. Data on file. 2015. 4. BioCryst Pharmaceuticals, Inc. Summary of clinical efficacy. Data on file. 2014.
Important Safety Information  

RAPIVAB® (peramivir injection) Important Safety Information

Indication

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.

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.

  • The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization.

Contraindications

RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.

Limitations of Use
  • Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketing experience with RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to RAPIVAB.

  • Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. There have been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatric patients. The contribution of Rapivab to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rapivab has not been shown to prevent such complications.

Adverse Reactions

The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% Rapivab vs 7% placebo). Lab abnormalities (incidence ≥2%) occurring more commonly with Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 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%).

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).

Concurrent Use with Live Attenuated Influenza Vaccine

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy). The concurrent use of Rapivab with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

Please see full prescribing information for Rapivab.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates.