Rapivab

RAPIVAB- peramivir solution
BioCryst Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

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 [see Microbiology (12.4)].
• The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.3)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Acute Uncomplicated Influenza

Administer RAPIVAB within 2 days of onset of symptoms of influenza.

Adults and Adolescents (13 years of age and older)

The recommended dosage of RAPIVAB in adult and adolescent patients 13 years of age and older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.

Pediatric Patients (6 months to 12 years of age)

The recommended dosage of RAPIVAB in pediatric patients 6 months to 12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), 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 adult subjects with renal dysfunction [see Clinical Pharmacology (12.3)]. Therefore, the RAPIVAB dosage should be reduced for patients with baseline creatinine clearance below 50 mL/min using the recommendations in Table 1 and Table 2. No dosage adjustment is required for single administration of RAPIVAB in patients with creatinine clearance of 50 mL/min or higher [see Clinical Pharmacology (12.3)].

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 and Table 2) [see Clinical Pharmacology (12.3)].

Table 1. Dosage Adjustment for Adults and Adolescents (13 Years and Older) with Altered Creatinine Clearance

	Creatinine Clearancea (mL/min)
	≥50	30 to 49	10 to 29
a Calculated using the Cockcroft and Gault equation.
Recommended Dose (mg)	600 mg	200 mg	100 mg

Table 2. Dosage Adjustment for Pediatric Patients (2 to 12 Years of Age) with Altered Creatinine Clearance

	Creatinine Clearancea (mL/min)
	≥50	30 to 49	10 to 29
a Calculated using the Cockcroft and Gault equation.
b Up to maximum dose of 600 mg.
Recommended Dose (mg/kg)b	12 mg/kg	4 mg/kg	2 mg/kg

No data are available to inform a recommendation for dosage adjustment with RAPIVAB in pediatric patients 6 months to less than 2 years of age with creatinine clearance less than 50 mL/min [see Use in Specific Populations (8.4, 8.6), Clinical Pharmacology (12.3)].

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 (2.1, 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.

Table 3. Maximum Infusion Volume by Age and Weight

Age	Weight (kg)	Maximum Infusion Volumea (mL)
a Infusion volume is the total volume of RAPIVAB 10 mg/mL solution and diluent. The final concentration of diluted RAPIVAB for administration should be between 1 mg/mL and 6 mg/mL.
Infants 6 months to 1 year of age	Any	25 mL
Adults and pediatric patients 1 year and older	5 kg to less than 10 kg	25 mL
	10 kg to less than 15 kg	50 mL
	15 kg to less than 20 kg	75 mL
	At least 20 kg	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.