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Rapivab
Clinical Evidence
in Pediatric Patients

Rapivab is FDA approved for people aged 2 years and older.1

Rapivab has a demonstrated safety profile in pediatric patients1

The safety and effectiveness of Rapivab for the treatment of influenza has been established in pediatric patients aged 2 years and older.

The primary endpoint was safety as measured by adverse events, laboratory analysis, vital signs, and physical exams.

  • Safety was assessed in 110 pediatric patients ages 2 to 17 years with acute uncomplicated influenza who received a single dose of Rapivab (n = 88) within 48 hours of symptom onset or 5 days of treatment with oseltamivir (n = 22)
  • Safety profile of Rapivab in pediatric patients 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% vs 9% for oseltamivir), fever (2% vs 0% for oseltamivir), and tympanic membrane erythema (2% vs 0% for oseltamivir)a

a The only clinically significant laboratory abnormality occurring in ≥2% of pediatric subjects treated with Rapivab was proteinuria by dipstick analysis (3% vs 0% for oseltamivir).

  • Safety Trial Design

    The safety and effectiveness in pediatric patients was established in a randomized, active-controlled study in subjects with acute uncomplicated influenza who reported onset of symptoms within 48 hours. Patients were randomized to receive Rapivab (n = 88) 600 mg (13-17 years of age) and Rapivab 12 mg/kg up to a maximum dose of 600 mg (2-12 years of age), or oral oseltamivir twice a day for 5 days (n = 22). All enrolled subjects were allowed to take fever-reducing medications. Eligible patients had a fever ≥37.8°C (oral) with at least one respiratory symptom (cough or rhinitis) or a positive influenza rapid antigen test.1

  • Median time to resolution of flu symptoms and fever in pediatric patients aged 2 years and older who received a single dose of Rapivab1,b

  • Clinical Study Design

    Study design in pediatric patient population1

    A randomized, multicenter, open-label, active-controlled trial was performed to evaluate the safety, pharmacokinetics and efficacy of a single intravenous dose of Rapivab administered for a minimum of 15 minutes in subjects 2 to 17 years of age (n = 88) with acute uncomplicated influenza who had fever greater than or equal to 37.8°C (oral) with at least one respiratory symptom (cough or rhinitis) or a positive influenza rapid antigen test. Study treatment was started within 48 hours of onset of symptoms. Subjects were randomized to receive Rapivab 600 mg (13 to 17 years of age), Rapivab 12 mg/kg up to a maximum dose of 600 mg (2 to 12 years of age), or oral oseltamivir BID for 5 days. In addition, all enrolled subjects were allowed to take fever-reducing medications.

    The overall efficacy population, consisting of subjects with confirmed influenza and administered study drug, totaled 84 subjects. Among the 69 subjects treated with Rapivab, the median age was 7.9 years; 55% were male; 58% were infected with influenza A virus, 36% were infected with influenza B virus, and 6% were co-infected with influenza A and B viruses.

    The primary endpoint was the safety of peramivir compared to oseltamivir as measured by adverse events, laboratory analysis, vital signs and physical exams. Secondary endpoints included efficacy outcomes such as time to resolution of influenza symptoms and time to resolution of fever; however, the trial was not powered to detect statistically significant differences in these secondary endpoints. Subjects receiving Rapivab experienced a median time to alleviation of their combined influenza symptoms of 79 hours (interquartile range: 34-122 hours). The median time to recovery to normal temperature (less than 37°C) was 40 hours (interquartile range:19-68 hours).1

Reference: 1. Rapivab [package insert]. Summit, NJ: Seqirus USA Inc; 2017.
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.