The first and only full course of antiviral flu therapy in a single dose.1,2
- Only one 15- to 30-minute IV infusion required.
- Treats acute uncomplicated influenza in patients 2+ who have been symptomatic for no more than 2 days
- Appropriate for many patients, including those who cannot tolerate or may be noncompliant with oral flu treatment and those requiring IV hydration
- Can be used with OTC supportive therapies
RAPIVAB injection is a clear, colorless sterile, isotonic solution. Each single-use vial contains 200 mg per 20 mL (10 mg/mL) of peramivir in a clear glass vial (NDC # 61364-181-01). RAPIVAB injection is supplied in cartons containing three single-use vials (NDC # 61364-181-03).
Storage and Handling
- Store vials of RAPIVAB injection in original cartons at 20° to 25°C (68° to 77°F).
- Excursions are permitted to 15° to 30°C (59° to 86°F).
- Do not use if seal over bottle opening is broken or missing.
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.
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.
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 greater than 160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%) and neutrophils less than 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/medwatch or call 1-800-FDA-1088.
- RAPIVAB [package insert]. Durham, NC: BioCryst Pharmaceuticals, Inc; 2014.
- 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. Doi:10.1128/AAC.0074-10.