Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations

Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations
[11/23/19/2009]

The U.S. Food and Drug Administration (FDA) has updated the Peramivir IV Fact Sheet for Health Care Providers to revise dosing recommendations for patients with end-stage renal disease on intermittent hemodialysis and for patients with renal failure with a creatinine clearance <10 mL/min who are NOT on hemodialysis. In addition, new dosing recommendations for patients undergoing continuous renal replacement therapy (CRRT) were added. The Fact Sheet for Health Care Providers authorized by FDA on November 19, 2009 replaces the original Fact Sheet authorized on October 23, 2009. Health care providers must now use this new version of the Fact Sheet.

The updated renal dosing recommendations for patients on intermittent hemodialysis are based on modeling and simulation analysis of pharmacokinetic data from a study conducted by the manufacturer (Biocryst) in patients with different degrees of renal impairment. The study showed that the systemic exposures of peramivir in patients with renal impairment were significantly higher than the systemic exposures of peramivir in adult patients with normal renal function when administered Peramivir IV 600mg, thereby highlighting the need to adjust dosing of Peramivir IV in patients with renal impairment.

The Fact Sheet for Health Care Providers provides adult and pediatric dosing adjustment recommendations for the following patients:

Mild renal impairment, creatinine clearance (CrCl) 50-80 mL/min
Moderate renal impairment, CrCl 31-49 mL/min
Severe renal impairment, CrCl 10-30 mL/min
Renal failure with CrCl < 10 mL/min and NOT on intermittent hemodialysis or continuous renal replacement therapy
End-Stage Renal Disease (CrCl < 10 mL/min) on intermittent hemodialysis
The Fact Sheet for Health Care Providers also outlines dosage adjustments for adult and pediatric patients to be used for the following cases:

On continuous veno-venous hemofiltration (CVVH) or other continuous renal replacement therapy (CRRT) including:
Continuous ultrafiltration (SCUF)
Continuous arterio-venous hemofiltration (CAVH)
Continuous arterio-venous hemodialysis (CAVHD)
Continuous veno-venous hemodialysis (CVVHD)
Continuous arterio-venous hemodiafiltration (CAVHDF)
Continuous veno-venous hemodiafiltration (CVVHDF)
The dosage adjustments for patients undergoing continuous renal replacement therapy (CRRT) are based on very limited data from patients undergoing CRRT who received Peramivir IV under an emergency IND; considerations of the various types of CRRT as outlined in the published literature; and the physicochemical properties of Peramivir IV. Consultation with the healthcare professional managing the CRRT is recommended when using Peramivir IV in these patients.

The recommended doses are intended to provide patients with renal impairment the same daily systemic peramivir exposures as those observed in adult patients with normal renal function receiving the recommended 600mg once daily IV dose. Healthcare professionals should review the Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV for additional renal dosing information. For complete information on the appropriate use of Peramivir IV, refer to the Peramivir IV Fact Sheet for Health Care Providers .

On October 23, 2009, FDA issued an Emergency Use Authorization (EUA) for the use of Peramivir IV in certain hospitalized patients with 2009 H1N1 infection as part of the federal government’s response to the 2009 H1N1 flu public health emergency.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

Considerations for Healthcare Professionals:

Review the Peramivir IV Fact Sheet for Health Care Providers for complete information on the appropriate use of Peramivir IV.
Review the Questions and Answers for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV for additional renal dosing information.
All patients with known or suspected renal impairment must have a creatinine clearance determined and dosing of Peramivir IV adjusted as outlined in the Fact Sheet.
A loading dose is not indicated for patients with mild, moderate, or severe renal impairment, including patients who have end stage renal disease and are on intermittent hemodialysis.
A loading dose is recommended for patients with a creatinine clearance <10 mL/min and NOT on intermittent hemodialysis or continuous renal replacement therapy.
The renal dosing recommendations are intended to provide similar systemic peramivir exposure as that observed in adult patients with normal renal function receiving the recommended 600 mg once daily dose.
Estimation of drug clearance by CRRT and residual renal function must be made for patients receiving continuous veno-venous hemofiltration (CVVH) or other continuous renal replacement therapy (CRRT) before determining the Peramivir IV dose. Consultation with the healthcare professional managing the CRRT is recommended.
The compatibility of Peramivir IV with IV solutions or medications other than Sodium Chloride Injection, USP is not known. To the extent possible, a separate IV line or separate IV lumen in a multilumen catheter is recommended for infusion of Peramivir IV.
Selected adverse events and all medication errors associated with the use of Peramivir IV must be submitted to FDA’s MedWatch program using the FDA Form 3500. Refer to the Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA for additional information.

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Information for Healthcare Professionals: Peramivir IV Renal Dosing Recommendations