Peramivir -rapivab™

RAPIVAB™ (peramivir injection)

Usual Diluents

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

Creatinine Clearance ≥ 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

WARNINGS 

DESCRIPTION 

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:

INDICATIONS AND USAGE 

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

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

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 

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 

Storage and Stability

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.

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