Monday November 2, 2009
Peramivir Fact Sheet for Health Care Providers

Source: http://www.cdc.gov/h1n1flu/eua/

As of October 23, 2009 as the request of the CDC the FDA authorized an Emergency Use of the investigational drug Peramivir, for the treatment of select adult and pediatric patients affected by the 2009 H1N1 influenza.

About Peramivir: It is an IV investigational neuraminidase inhibitor currently being evaluated in phase 3 clinical trials. Limited phase 2 and 3 safety and efficacy data are available, sufficient to allow emergency approval

Dosing: (adults) 600 mg IV once daily for 5-10 days

Renal adjustment needed: CrCl 50-60 ml/min 600mg IV daily; CrCl 31-49 ml/min 150mg IVdaily; CrCl 10-30 100mg IV daily; Hemodialysis or CrCl less than 10 ml/min 15 mg daily. Information is not available for those receiving peritoneal dialysis or CVVHD.

No hepatic dose adjustments needed.

Initial treatment course 5 or 10 days. Patients with critical illness may benefit from longer courses, no data available demonstrating increased efficacy

Administration: IV administration only. Infuse at a rate not to exceed 40mg/min. Dilute only in 0.9% sodium chloride. NOT compatible with dextrose solutions. Stable 24 hours refrigerated once constituted and diluted

Pharmacokinetics - T1/2: 7.7-20.8 hours

Warning/Precaution: not shown to reduce risk of transmission of influenza to others; should not be used in those with documented or highly suspected oseltamivir resistence; caution should be used in those with documented or highly suspected zanamivir resistence; In rare cases, peramivir may be associated with anaphylaxis an serious skin reactions, and a variety of neurologic and behavioral symptoms

Adverse events: diarrhea, nausea, vomiting, neutropenia are commonly reported in clinical trials. All medication errors and selected adverse events should be reported to the FDA Med Watch as this is still an investigational drug.