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