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IV Dilution Guidelines- RAPIVAB™ (peramivir injection)

RAPIVAB™ (peramivir injection)

[ Usual Diluents ] [ Standard Dilution ] [ Storage and Stability ]
DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

Drug UPDATES:   [Drug information  /  PDF]  
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)
 

Usual Diluents top of page

NS,  D5W,  0.45% sodium chloride, or lactated Ringer's

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate] top of page

Total volume should not exceed 100mL.

Creatinine Clearance geq 50 mL/min:
[600 mg (60ml)]   [40 ml]  [15-30 minutes]

Creatinine Clearance 30-49 mL/min:
[200 mg (20ml)]   [80 ml]  [15-30 minutes]

Creatinine Clearance 10-29 mL/min:
[100 mg (10ml)]   [90 ml]  [15-30 minutes]

In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis


Stability data:

Stability
Refrigerated
Stability
Room Temp.
Reconstituted
Vial/Powder
Notes P-Insert
Updated
Solution:  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.  Vial: Discard any unused diluted solution of RAPIVAB after 24 hours.  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).

  Revised: 12/2014

WARNINGS  top of page

See warnings and precautions below.


DESCRIPTION  top of page

Description:
RAPIVAB™ (peramivir injection), for intravenous use
Initial U.S. Approval: [2014]

RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells. The median neuraminidase inhibitory activity (IC50 values) of peramivir in biochemical assays against influenza A/H1N1 virus, influenza A/H3N2 virus, and influenza B virus clinical isolates were 0.16 nM (n=44; range 0.01-1.77 nM), 0.13 nM (n=32; range 0.05-11 nM), and 0.99 nM (n=39; range 0.04-54.2 nM), respectively, in a neuraminidase assay with a fluorescently labeled MUNANA substrate.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
RAPIVAB is an influenza virus neuraminidase inhibitor indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.

Limitations of Use:
-Efficacy 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.
-Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.
-Efficacy could not be established in patients with serious influenza requiring hospitalization.

USE IN SPECIFIC POPULATIONS
Pregnancy: Use if benefit outweighs risk.
Nursing mothers: Caution should be exercised when administered to a nursing woman.

CONTRAINDICATIONS top of page

Contraindications:
None

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS:
  1.  Serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB.
  2. 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.

ADVERSE REACTIONS top of page

ADVERSE REACTIONS:

Most common adverse reaction (incidence >2%) is diarrhea (6)

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-844-273-2327 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION::
2.1 Dosage in Acute Uncomplicated Influenza
Administer RAPIVAB within 2 days of onset of symptoms of influenza.

The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

2.2 Dosing in Patients with Renal Impairment
Significantly increased drug exposures were observed when RAPIVAB was administered to subjects with renal dysfunction. Therefore, the RAPIVAB dose should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1. No dose adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher.

In patients with chronic renal impairment maintained on hemodialysis, RAPIVAB should be administered after dialysis at a dose adjusted based on renal function (Table 1).

Table 1. Dosage Adjustment for Patients with Altered Creatinine Clearance
Creatinine Clearance* (mL/min)
>/=50 - Recommended Dose (mg) 600
30-49 - Recommended Dose (mg) 200
10-29 - Recommended Dose (mg) 100
*Calculated using the Cockcroft and Gault equation.

2.3 Preparation of RAPIVAB for Intravenous 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.

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

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

(b) Visually inspect RAPIVAB for particulate matter and discoloration prior to administration.

(c) Dilute an appropriate dose of RAPIVAB 10 mg/mL solution [see Dosage and Administration (2)] in 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's to a maximum volume of 100 mL.

(d) Administer the diluted solution via intravenous infusion for 15 to 30 minutes.

(e) 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.

2.4 Drug Compatibility

RAPIVAB injection is compatible with 0.9% or 0.45% sodium chloride, 5% dextrose, or lactated Ringer's. Do not mix or co-infuse RAPIVAB with other intravenous medications.

RAPIVAB injection is compatible with materials commonly used for administration such as polyvinylchloride (PVC) bags and PVC-free bags, polypropylene syringes, and polyethylene tubing


HOW SUPPLIED  top of page

DOSAGE FORMS AND STRENGTHS:
Injection: 200 mg in 20 mL (10 mg/mL) in a single-use vial

Storage and Stability top of page

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).

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.


Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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