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peramivir (Rapivab)

 

Classes: Neuraminidase Inhibitors; Antivirals, Influenza

Dosing and uses of Rapivab (peramivir)

 

Adult dosage forms and strengths

IV solution

  • 200mg/20mL (10mg/mL)

 

Influenza

Indicated for treatment of acute uncomplicated influenza in patients aged &ge:18 yr who have been symptomatic for no more than 2 days

600 mg IV as a single dose

Infuse diluted IV over 15-30 minutes

 

Dosage modifications

Renal impairment

  • CrCl 30-49 mL/min: 200 mg IV as a single dose
  • CrCl 10-29 mL/min: 100 mg IV as a single dose

 

Dosing Considerations

Limitations of use

  • Efficacy based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled
  • Influenza viruses change over time and emergence of resistance substitutions could decrease drug effectiveness
  • Efficacy could not be established in patients with serious influenza requiring hospitalization

 

Pediatric dosage forms and strengths

<18 years: Safety and efficacy not established

 

Rapivab (peramivir) adverse (side) effects

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

 

Warnings

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 and lactation

Pregnancy category C; No data available for use during pregnancy

Lactation: unknown whether distributed in breast milk, do not nurse

 

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.

 

Pharmacology of Rapivab (peramivir)

Mechanism of action

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

 

Administration

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

 

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