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Dosing &
Administration

 

One 15- to 30-minute intravenous (IV) infusion provides a full course of antiviral influenza treatment1

Use these dosing guidelines to determine the dosage of Rapivab® (peramivir injection) for your patients.

 
 
 

aIn patients with chronic renal impairment maintained on hemodialysis, Rapivab should be administered after dialysis at a dose adjusted based on renal function.1

bCalculated using the Cockcroft and Gault equation.

The administration of Rapivab in patients with renal impairment is at the discretion of the treating physician.

 

Preparation of Rapivab for IV infusion

Use aseptic technique during the preparation of Rapivab to prevent inadvertent microbial contamination. There is no preservative or bacteriostatic agent present in the solution.1

Follow the steps below to prepare a diluted solution of Rapivab1:

 

1. Do not use if seal over bottle opening is broken or missing.

2. Visually inspect Rapivab for particulate matter and discoloration prior to administration.

3. Dilute an appropriate dose of Rapivab 10 mg/mL solution in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s to a maximum volume of 100 mL.

4. Administer the diluted solution via intravenous infusion for 15 to 30 minutes.

5. Discard any unused diluted solution of Rapivab after 24 hours.

Once a diluted solution of Rapivab has been prepared, administer immediately or store under refrigerated conditions (2°-8°C or 36°-46°F) for up to 24 hours. If refrigerated, allow the diluted solution of Rapivab to reach room temperature, then administer immediately.

Do not use if seal over bottle opening is broken or missing.

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

Important Safety Information

Rapivab® (peramivir injection) 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.

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.

Warnings and Precautions
  • 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.

  • Patients with influenza may be at an increased risk of hallucinations, delirium, and abnormal behavior early in their illness. 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 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%).

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 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/Safety/MedWatch/ or call 1-800-FDA-1088.