peramivir (Rx)

1-10%

Diarrhea (8%)

Neutrophils <1 x 10^9/L (8%)

Increased serum glucose (>160 mg/dL) (5%)

Creatine phosphokinase (≥6 xULN) (5%)

Constipation (4%)

Insomnia (3%)

AST and ALT increased (3%)

Hypertension (2%)

Postmarketing Reports

Dermatologic: Stevens-Johnson syndrome, exfoliative dermatitis, rash

General disorders and administration site conditions: anaphylactic/anaphylactoid reactions

Psychiatric: abnormal behavior, hallucination

Contraindications

Known serious hypersensitivity or anaphylaxis to peramivir or any component of the product; severe allergic reactions have included anaphylaxis, erythema multiforme, and Stevens-Johnson Syndrome

Cautions

Serious skin reactions reported including erythema multiforme and Stevens-Johnson syndrome; discontinue and initiate appropriate treatment (see Contraindications)

Influenza can be associated with neurologic and behavioral symptoms including hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes

Pregnancy

Limited available data with use in pregnant women are insufficient to determine a drug- associated risk of adverse developmental outcomes; there are risks to the mother and fetus associated with influenza in pregnancy

Animal studies

• Administered during organogenesis in rats

  • Dose 8 x human recommended dose
  • Single IV bolus injection: No adverse effects observed
  • Continuous IV infusion: Reduced renal papilla and dilated ureters were observed

• Administered in rabits

  • Administration of drug during organogenesis at exposures 8 times those in humans at recommended dose resulted in developmental toxicity (abortion or premature delivery) at a maternally toxic dose

Lactation

There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; drug is present in rat milk limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Elicits antiviral activity by inhibiting influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells

IV Compatibilities

0.9% NaCl

0.45% NaCl

Dextrose 5% in water

Lactated Ringer solution

IV Preparation

Contains no preservatives or bacteriostatic agents; do not use if seal over vial opening is broken or missing

Inspect vial for particulate matter and discoloration

Dilute appropriate dose in 0.9% or 0.45% NaCl, D5W, or lactated Ringer solution to a maximum volume of 100 mL

IV Administration

Administer IV over 15-30 minutes

Do not mix or coinfuse peramivir with other IV medications

Storage

Unopened vials: Store in original cartons at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F)

Diluted solution: Administer immediately or store refrigerated (2-8°C [36-46°F]) for up to 24 hr

If refrigerated, allow the diluted solution to reach room temperature then administer immediately