November 23, 2009
Revised Peramivir IV renal dosing recommendations for H1N1 influenzaThe FDA has updated the Peramivir IV (from BioCryst) Fact Sheet for Healthcare 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 <10mL/min who are not on hemodialysis. Additionally, new dosing recommendations were added for patients undergoing continuous renal replacement therapy.
The updated renal dosing recommendations for patients on intermittent hemodialysis are based on pharmacokinetic data from a study conducted by Biocryst in patients with different degrees of renal impairment. Study results showed that the systemic exposures of peramivir in patients with renal impairment were significantly higher than that of 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.
Peramivir IV is an investigational drug for which the FDA has issued an Emergency Use Authorization for use in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191472.htm.