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Peramivir Fact Sheet for Health Care Providers (cont.)

DRUG INTERACTIONS

Peramivir IV is primarily eliminated by the kidneys; coadministration of Peramivir IV with drugs that reduce renal function or compete for active tubular secretion may increase plasma concentrations of Peramivir IV and/or increase the concentrations of other renally eliminated drugs.

Drug-drug interaction trials of Peramivir IV and other concomitant medications have not been conducted. Use with caution with other medications which are eliminated by the kidneys and monitor the patient's renal function as appropriate.

Use In Specific Populations

Pregnancy

No adequate and well-controlled studies of Peramivir use in pregnant women have been conducted. Peramivir IV should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

No teratogenicity was detected in fertility and developmental studies conducted in both rats and rabbits. When comparing to systemic Peramivir exposures at the 600 mg IV dose in humans (predicted AUC = 90 µg*h/ml), the exposures in rats are 8.4 times the human exposure and the exposures in rabbits are 1.5 times the human exposure at the 600 mg dose given intravenously. Peramivir administered intravenously at 200 mg/kg, caused severe maternal toxicity (dose-limiting nephrosis) in pregnant rabbits, and an increased incidence of abortion and embryotoxicity, considered to be related to the maternal toxicity. Rabbits are considered a sensitive species and nephrotoxicty has been observed in non-pregnant rabbits in general toxicology studies. The margin of safety for nephrotoxicity in non-pregnant rabbits, as compared with predicted AUC of 90 µg*h/ml at 600 mg IV dose in humans, is less than 1. In contrast to rabbits, Peramivir did not produce significant maternal toxicity nor embryotoxicity (up to 600 mg/kg) in pregnant rats.

Nursing Mothers

Peramivir has not been studied in nursing mothers. Studies in rats demonstrated Peramivir is excreted in milk. Lactating rats excreted Peramivir into the milk, at levels below the mother's plasma drug concentrations. However, nursing mothers should be instructed that it is not known whether Peramivir is excreted in human milk.

Pediatric Use

Peramivir has not been administered to any pediatric patients (age < 18 years) in clinical trials. However, limited use of Peramivir IV in adults and children has been allowed for Peramivir IV 600 mg once daily for 5 to 10 days under emergency IND procedures.

The safety and effectiveness of Peramivir IV for treatment of influenza has not been assessed in pediatric patients. Dosing instructions for pediatric patients were derived based on modeling and simulation of pharmacokinetic data from adult healthy volunteers and adult patients with influenza and information on renal maturation and body weight [see Dose Rationale].

Geriatric Use

Clinical studies of Peramivir do not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, appropriate caution should be exercised in the administration of Peramivir IV and monitoring of elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Sixteen healthy volunteers ≥ 65 years of age received twice-daily doses of 4 mg/kg for 1, 5, and 10 days. Too few patients ≥ 65 years of age have received Peramivir to make conclusions about the overall safety profile compared to adult patients < 65 years of age [see Special Populations].



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