Rapivab® (peramivir injection)

Rapivab

INDICATION

Rapivab is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.

  • Efficacy of Rapivab was 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.
  • 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.
  • Efficacy could not be established in patients with serious influenza requiring hospitalization.

IMPORTANT SAFETY INFORMATION

Contraindications

None

Warnings and Precautions

Rare cases of serious skin reactions, including Stevens-Johnson syndrome and erythema multiforme have occurred with Rapivab. Appropriate treatment should be instituted if a serious skin reaction occurs or is suspected.

Patients with influenza may be at an increased risk of hallucinations, delirium and abnormal behavior early in their illness. There have been post-marketing 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. 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 (incidence >2%) is diarrhea (8% Rapivab vs. 7% placebo).

Lab abnormalities (incidence >2%) occurring more commonly than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs. 2%), elevated serum glucose greater than 160 mg/dL (5% vs 3%), elevated CPK more than 6 times the upper limit of normal (4% vs. 2%) and neutrophils less than 1.0 x 10^9/L (8% vs. 6%).

Concurrent use with Live Attenuated Influenza Vaccine

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV). 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 LAIV within 2 weeks before or 48 hours after administration of Rapivab unless medically indicated.