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Peramivir Fact Sheet for Health Care Providers (cont.)

OTHER CONSIDERATIONS PRIOR TO PERAMIVIR IV USE

In addition to the information presented above FDA recommends (but does not require) considerations of the following information before use of Peramivir IV, some of which is provided in more detail in other parts of this document:

Data Available on Safety and Efficacy

  • The efficacy and safety of Peramivir IV (or the other approved neuraminidase inhibitors) have not been established in hospitalized patients with any type of influenza A or B virus including 2009 H1N1 virus.
  • Results from the phase 2 and 3 trials with IV and intramuscular (IM) administration include a statistically significant effect of a single 300 mg IV or 600 mg IV dose of Peramivir compared to placebo in adult patients with acute uncomplicated influenza. Additionally, three phase 2 trials and one phase 3 trial, including one trial in hospitalized patients, did not show statistically significant treatment differences between Peramivir and placebo or oseltamivir.
  • Approximately 1,891 clinical trials subjects have received Peramivir given IV or IM, including 478 who received a single dose of 600 mg IV. Data on multi-dose administration are limited with 33 adult clinical trial subjects who received approximately 600 mg (or higher) intravenously once daily for five or more days.
  • No pediatric patients (age < 18 years) have received Peramivir in clinical trials. No pharmacokinetic, safety or efficacy data are available in the pediatric population. However, limited use of Peramivir IV in children has been allowed for Peramivir IV 600 mg once daily for 5 to 10 days under emergency IND procedures.
  • Limited safety data from adults are available on Peramivir IV use for 5 days or longer. However, limited use of Peramivir IV in adults has been allowed for Peramivir IV 600 mg once daily for 5 to 10 days under emergency IND procedures.
  • Peramivir has not been administered to pregnant women or nursing mothers in clinical trials. No pharmacokinetic, safety or efficacy data are available in pregnant women or nursing mothers.
  • Use of Peramivir has not been shown to reduce the risk of transmission of influenza to others.

Treatment Regimens and Timeliness

  • Empiric antiviral treatment of hospitalized patients with suspected influenza should not be delayed pending laboratory confirmation of influenza because antiviral treatment is most effective when initiated as early as possible. In addition, a negative influenza antigen test (rapid influenza diagnostic test or immunoflorescence) does not rule out influenza virus infection.
  • Initial treatment courses of 5 days or 10 days are permitted. Patients with critical illness (for example, those with respiratory failure or those requiring intensive care unit admission) might benefit from a longer treatment course, although there are no available data demonstrating that longer treatment courses are more effective. Limited data are available on the use of Peramivir IV for up to 10 days or longer.
  • Peramivir IV can be used at any time after onset of symptoms in hospitalized patients; however, no data are available regarding initiation of Peramivir IV beyond 72 hours after symptom onset.

Drug Resistance

  • 2009 H1N1 virus strains circulating worldwide are susceptible to the neuraminidase inhibitor class of antivirals (oseltamivir, zanamivir, Peramivir IV), and resistant to the adamantane class (amantadine, rimantadine). Rare, sporadic cases of oseltamivir-resistant virus infection associated with the H275Y mutation in the neuraminidase have been reported, including in the United States. To date, there is no evidence worldwide of on-going community-wide transmission of oseltamivir-resistant 2009 H1N1 virus. The latest antiviral resistance surveillance data for the United States can be found at: http://www.cdc.gov/flu/weekly/.
  • Peramivir IV should not be used for treatment of 2009 H1N1 virus infection in patients with documented or highly suspected oseltamivir resistance.
  • Peramivir IV should be used with caution in patients with documented (neuraminidase E119D or R292K) or highly suspected zanamivir resistance. The activity of Peramivir IV against zanamivir resistant virus is unknown.
  • Limited data are available on the combination antiviral activity relationships of Peramivir with oseltamivir. No data are available on the combination antiviral drugs, although combination of Peramivir with oseltamivir in a mouse influenza A virus challenge study demonstrated additive antiviral activity compared to use of a single agent alone. The clinical significance of these data is unknown.


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