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Peramivir Fact Sheet for Health Care Providers (cont.)

1. AUTHORIZED USE:

Peramivir injection is authorized for use under an EUA for treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, Peramivir IV is authorized only for the following patients who are admitted to a hospital:

  1. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
    1. patient not responding to either oral or inhaled antiviral therapy, or
    2. drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
    3. the clinician judges IV therapy is appropriate due to other circumstances.
  2. Pediatric patients for whom an IV agent is clinically appropriate because:
    1. patient not responding to either oral or inhaled antiviral therapy, or
    2. drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.

DOSAGE AND ADMINISTRATION

All patients with known or suspected renal insufficiency must have creatinine clearance determined and dosing of Peramivir IV adjusted accordingly [see Impaired Renal Function].

Initial treatment courses are for 5 to 10 days duration. Treatment beyond 10 days is permitted depending on clinical presentation such as critical illness (e.g., respiratory failure or intensive care unit admission), continued viral shedding or unresolved clinical influenza illness.

Do not administer as an intramuscular (IM) injection.

Adult Patients ( ≥ 18 years)

The recommended adult dose is 600 mg given intravenously over 30 minutes once daily for 5 to 10 days. Adult patients with known or suspected renal insufficiency must have creatinine clearance determined and the dose adjusted according to Table 1.

Infusion rates should not exceed 40 mg per minute. Peramivir IV must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes [see Directions For Use of Peramivir Injection]. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride.

Adults with Impaired Renal Function

The dose of Peramivir IV should be adjusted in adult patients with renal impairment as follows: [see Special Populations, Renal Impairment]

Table 1: Adult Impaired Renal Function Daily Dosage Recommendations

Renal Impairment or Hemodialysis Creatinine Clearance Daily Dose (IV)
Mild Renal Impairment CrCl 50-80 mL/min 600 mg
Moderate Renal Impairment CrCl 31-49 mL/min 150 mg
Severe Renal Impairment CrCl 10-30 mL/min 100 mg
Hemodialysis or CrCl < 10 mL/min 15 mg
The dose should be adjusted in patients with impaired renal function (CrCL less than 50 mL/min).
# On dialysis days, Peramivir IV should be administered after hemodialysis is completed.

When only a serum creatinine determination is available, the following formula (Cockcroft and Gault equation)1 may be used to estimate creatinine clearance in adults. The serum creatinine should represent a steady state of renal function.

Males: Creatinine Clearance (mL/min) = Weight (kg) x (140 – age)
72 x serum creatinine (mg/dL)
Females: 0.85 x above value  

There is no information available specific to the administration of Peramivir IV in patients receiving peritoneal dialysis or Continuous Veno-Venous Hemofiltration (CVVH) dialysis.

Pediatric Patients from birth through 17 years of age

Dosing in pediatric patients is based upon modeling. No pediatric patients have received Peramivir in clinical trials [see Dose Rationale]. However, limited use of Peramivir IV in children has been allowed for Peramivir IV 600 mg once daily for 5 to 10 days under emergency IND procedures.

The recommended pediatric dose should be calculated using the mg/kg dose according to the patient's age (See Table 2). Pediatric patients with known or suspected renal insufficiency must have creatinine clearance determined and the dose adjusted according to Table 3.

The calculated dose should be infused intravenously over 60 minutes once daily. Initial treatment courses of 5 days or 10 days are permitted.

The maximum daily dose should not exceed 600 mg IVof Peramivir injection. Infusion rates should not exceed 40 mg per minute. Peramivir injection must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes [see Directions For Use of Peramivir Injection]. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride.

Table 2: Pediatric Daily Dosage Recommendations*

Age Dose (mg/kg)
Birth through 30 Days 6 mg/kg
31 Days through 90 Days 8 mg/kg
91 Days through 180 Days 10 mg/kg
181 Days through 5 Years 12 mg/kg
6 Years through 17 Years 10 mg/kg
*Maximum Daily Dose is 600 mg IV

Pediatric Patients with Impaired Renal Function

The dose of Peramivir IV should be adjusted in pediatric patients with different degrees of renal impairment as follows: [see Special Populations, Renal Impairment– Pediatric Patients]

Table 3: Pediatric Impaired Renal Function Daily Dosage Recommendations

Age CrCl (ml/min)
50-80 ml/min 31-49 ml/min 10-30 ml/min < 10 ml/min or hemodialysis#
Birth through 30 days 6 mg/kg QD 1.5 mg/kg QD 1 mg/kg QD 0.15 mg/kg QD
31 Days through 90 Days 8 mg/kg QD 2 mg/kg QD 1.3 mg/kg QD 0.2 mg/kg QD
91 Days through 180 Days 10 mg/kg QD 2.5 mg/kg QD 1.6 mg/kg QD 0.25 mg/kg QD
181 Days through 5 Years 12 mg/kg QD 3.0 mg/kg QD 1.9 mg/kg QD 0.3 mg/kg QD
6 Years through 17 Years 10 mg/kg QD 2.5 mg/kg QD 1.6 mg/kg QD 0.25 mg/kg QD
# On dialysis days, Peramivir IV should be administered after hemodialysis is completed.

To estimate creatinine clearance in children, the Schwartz formula2 may be used. A link to a website using the Schwartz formula to calculate creatinine clearance in children can be found at:

http://www-users.med.cornell.edu/~spon/picu/calc/crclschw.htm

There is no information available specific to the administration of Peramivir IV in patients receiving peritoneal dialysis or Continuous Veno-Venous Hemofiltration (CVVH) dialysis.

Impaired Hepatic Function

Based on the available data, Peramivir IV is not significantly metabolized by the liver. Therefore, no dose adjustment is necessary for patients with impaired hepatic function.

Directions For Preparing Peramivir Injection

Method of Preparation: See the following detailed preparation directions for adult and pediatric use.

Preparation of Peramivir IV infusion should be done under aseptic conditions.

Adult Dose Preparation Directions

Follow the steps below to prepare a diluted solution of Peramivir IV 600 mg for adult patients with normal renal function. The dose of Peramivir IV should be adjusted in adult patients with renal impairment according to Table 1. Peramivir injection must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride.

  1. Transfer 600 mg (60 mL, or appropriate volume based on recommended dose for patients with renal impairment in Table 1) of Peramivir injection to an empty sterile container for IV use.
  2. Add 40 mL (or appropriate volume to reach a total of 100 mL based on the adjusted renal dose) of 0.9% or 0.45% Sodium Chloride Injection, USP to the container. The total volume of diluted solution should be 100 mL with a maximum final concentration of 6 mg/mL.

Pediatric Dose Preparation Directions: (age birth through 17 years of age)

Follow the steps below to prepare a diluted solution of Peramivir injection. Peramivir injection must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride.

  1. Calculate the recommended age-based dose according to Table 2. Refer to Table 3 to calculate the recommended dose for pediatric patients with known or suspected renal insufficiency.
  2. Dilute the calculated dose using 0.9% or 0.45% Sodium Chloride Injection, USP in an empty sterile container for IV use. The final concentration of the diluted solution should not exceed 6 mg/mL. The diluted solution should be administered intravenously over 60 minutes.
    OR
  3. An undiluted dose must be administered using an infusion device, e.g., a piggy back system, timed syringe system or pump, which allows infusion into an open IV line with Sodium Chloride Injection, USP over 60 minutes.

Storage: Vials of Peramivir injection should be stored at ambient temperature (15°C-30°C or 59°F-86°F). However, temperature extremes encountered during shipment and storage (including freezing) would likely not adversely affect the quality of this product. Once a diluted solution has been prepared, it should be administered immediately or stored under refrigerated conditions (2°C-8°C or 36°F-46°F). If refrigerated, the refrigerated diluted solution should be allowed to reach room temperature prior to administration. The diluted solution should be administered within 24 hours following preparation. Any unused diluted solution must be discarded after 24 hours.

IMPORTANT:

Any unused portion of a single use Peramivir injection vial should be discarded after a diluted solution is prepared. Maintain adequate records showing receipt, use, and disposition of Peramivir. For unused intact vials, maintain adequate records showing use and disposition of Peramivir.

Peramivir injection is a clear-colorless solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.

The prepared diluted solution should not be administered simultaneously with any other medication. The compatibility of Peramivir injection with IV solutions and medications other than Sodium Chloride Injection, USP is not known. Peramivir injection must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes [see Directions For Use of Peramivir Injection]. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride.

Care should be taken during admixture to prevent inadvertent microbial contamination. As there is no preservative or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the final parenteral solution. It is always recommended to administer IV medication immediately after preparation when possible. The diluted solution of Peramivir IV must be discarded after 24 hours.

Dosage Forms And Strengths

Intravenous (IV) Injection:

  • Each vial of Peramivir injection contains 200 mg per 20 mL (10 mg per mL)


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