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 6 months of age and older.

 
 
 

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 [see Dosage and Administration (2.1, 2.2)] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer’s. The maximum infusion volume is provided in Table 3. The final concentration of diluted RAPIVAB for administration should be between 1 mg/mL and 6 mg/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° to 8°C or 36° to 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]. Durham, NC: BioCryst Pharmaceuticals, Inc; 2021.
Important Safety Information  

RAPIVAB® (peramivir injection) Important Safety Information

Indication

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months 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.

Warnings and Precautions

  • Cases of anaphylaxis and serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. Discontinue RAPIVAB and initiate appropriate treatment if anaphylaxis or serious skin reaction occurs or is suspected.

  • Neuropsychiatric events: Patients with influenza may be at an increased risk of hallucinations, delirium and abnormal behavior early in their illness. Monitor 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 6 months to 17 years of age was generally similar to that observed in adults. The only adverse reaction reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults was vomiting (3% versus 9% for oseltamivir). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB (and not previously reported in adults) 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. Avoid use of LAIV within 2 weeks before or 48 hours after administration of RAPIVAB, unless medically indicated.

Please see full prescribing information for RAPIVAB.

You are encouraged to report negative side effects of prescription drugs to the FDA. To report suspected adverse reactions, contact BioCryst Pharmaceuticals at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

RAPIVAB and BioCryst are registered trademarks of BioCryst Pharmaceuticals, Inc.


 

RAPIVAB is a registered trademark of BioCryst

BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, NC 27703

RAPIVAB and BioCryst are registered trademark of BioCryst Pharmaceuticals, Inc.
© 2022 BioCryst Pharmaceuticals, Inc.
All rights reserved. US.RAP.00012 6/22