Influenza, acute, uncomplicated: IV: 600 mg as a single dose; initiate within 2 days of onset of symptoms of influenza.
Influenza, hospitalized patients (alternative agent) (off-label use): IV: 600 mg once daily for up to 5 to 10 days (CDC 2020a; de Jong 2014; Ison 2014; Kohno 2011). Note: Due to insufficient data on use of peramivir for treatment of hospitalized patients with influenza, only consider for patients who cannot tolerate or absorb oral or enterically-administered oseltamivir due to gastric stasis, malabsorption, or GI bleeding (CDC 2020a).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Renal function may be estimated using the Cockcroft-Gault formula.
Uncomplicated influenza:
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: 200 mg as a single dose
CrCl 10 to 29 mL/minute: 100 mg as a single dose
ESRD requiring intermittent hemodialysis (IHD): 100 mg as a single dose, administered after dialysis
Hospitalized patients with influenza (FDA 2009):
CrCl ≥50 mL/minute: 600 mg once daily
CrCl 31 to 49 mL/minute: 150 mg once daily
CrCl 10 to 30 mL/minute: 100 mg once daily
CrCl <10 mL/minute (not on renal replacement therapy): 100 mg once daily on day 1, then 15 mg once daily beginning on day 2
ESRD requiring intermittent hemodialysis (IHD): 100 mg on day 1, then 100 mg given 2 hours after each dialysis session
Continuous renal replacement therapy (CRRT): Pharmacokinetic data indicate that peramivir is efficiently cleared by CRRT due to high sieving coefficient and low protein binding (Bazan 2010; Bentley 2014; Scheetz 2011). One suggested method for determining the dose of peramivir while on CRRT, assuming a sieving coefficient of 100% and negligible protein binding, is to estimate the patient’s total clearance based on the following equation and refer to the above renal dosage adjustments for dose selection (FDA 2009):
Total clearance = Residual renal function (mL/minute) + CRRT clearance (CLCRRT) (mL/minute)
CLCRRT can be determined as follows:
CVVH/Continuous arteriovenous hemofiltration (CAVH)/Slow continuous ultrafiltration (SCUF): Use ultrafiltration rate (mL/minute)
CAVHD/CVVHD: Use dialysate flow rate (mL/minute)
Continuous arteriovenous hemodialysis (CAVHDF)/CVVHDF: Use total of ultrafiltration rate and dialysate flow rate (mL/minute)
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, not significantly metabolized hepatically.
Refer to adult dosing.
(For additional information see "Peramivir: Pediatric drug information")
Influenza, treatment; acute, uncomplicated: Note: Administer within 2 days of onset of symptoms of influenza.
Infants ≥6 months and Children: IV: 12 mg/kg as a single dose; maximum dose: 600 mg/dose.
Adolescents: IV: 600 mg as a single dose.
Influenza, treatment ; hospitalized, high risk and/or epidemic (alternate agent): Limited data available; efficacy results variable; optimal dosing not established.
Note: Peramivir should be considered in patients who cannot tolerate or absorb oseltamivir (CDC 2021b). During the 2009 influenza season, peramivir was given as part of an Emergency Use Authorization in the United States for patients with pandemic A (H1N1) 2009 virus (FDA 2009). Subsequently, it has been studied but is not approved for use in hospitalized patients and/or patients with complicated influenza (de Jong 2014; Sugaya 2012; Witcher 2019). In a small pharmacokinetic study, 11 critically ill children demonstrated faster clearance than previously reported; however, additional studies are needed (Cies 2019).
Infants, Children, and Adolescents: IV:
29 to 30 days of life: 6 mg/kg/dose once daily for 5 to 10 days (FDA 2009; Hata 2014); others have used 10 mg/kg/dose once daily (Komeda 2015; Sugaya 2012).
31 to 90 days of life: 8 mg/kg/dose once daily for 5 to 10 days (FDA 2009; Hata 2014); others have used 10 mg/kg/dose once daily (Komeda 2015; Sugaya 2012).
91 to 180 days of life: 10 mg/kg/dose once daily for 5 to 10 days (FDA 2009; Hata 2014; Komeda 2015).
181 days of life through 5 years: 12 mg/kg/dose once daily for 5 to 10 days (FDA 2009; Hata 2014); others have used 10 mg/kg/dose once daily (Komeda 2015; Sugaya 2012); maximum daily dose: 600 mg/day.
6 to 17 years: 10 mg/kg/dose once daily for 5 to 10 days (FDA 2009; Hata, 2014; Komeda 2015); maximum daily dose: 600 mg/day.
≥18 years: 600 mg once daily for 5 to 10 days (Hata 2014).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents: IV:
Uncomplicated influenza:
Infants ≥6 months and Children <2 years: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Based on experience with older children and adolescents, dosage adjustment may be necessary.
Children ≥2 years and Adolescents:
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute:
Children ≥2 years: 4 mg/kg as a single dose; maximum dose: 200 mg/dose.
Adolescents: 200 mg as a single dose.
CrCl 10 to 29 mL/minute:
Children ≥2 years: 2 mg/kg as a single dose; maximum dose: 100 mg/dose.
Adolescents: 100 mg as a single dose.
End-stage renal disease requiring hemodialysis:
Children ≥2 years: 2 mg/kg as a single dose; maximum dose: 100 mg/dose, administered after dialysis.
Adolescents: 100 mg as a single dose; administered after dialysis.
Hospitalized (high-risk and/or epidemic) patients with influenza: Limited data available: Dosing adjustment based on recommendations from H1N1 epidemic 2009 to 2010 (FDA 2009):
Infants, Children, and Adolescents <18 years: Note: Dosage adjustment based on renal function estimated using the Schwartz equation.
CrCl ≥50 mL/minute/1.73 m2: No adjustment necessary.
CrCl 31 to 49 mL/minute/1.73 m2:
29 to 30 days of life: 1.5 mg/kg/dose once daily for 5 to 10 days.
31 to 90 days of life: 2 mg/kg/dose once daily for 5 to 10 days.
91 to 180 days of life: 2.5 mg/kg/dose once daily for 5 to 10 days.
181 days of life through 5 years: 3 mg/kg/dose once daily for 5 to 10 days; maximum dose: 150 mg/dose.
6 to 17 years: 2.5 mg/kg/dose once daily for 5 to 10 days; maximum dose: 150 mg/dose.
CrCl 10 to 30 mL/minute/1.73 m2:
29 to 30 days of life: 1 mg/kg/dose once daily for 5 to 10 days.
31 to 90 days of life: 1.3 mg/kg/dose once daily for 5 to 10 days.
91 to 180 days of life: 1.6 mg/kg/dose once daily for 5 to 10 days.
181 days of life through 5 years: 1.9 mg/kg/dose once daily for 5 to 10 days; maximum dose: 100 mg/dose.
6 to 17 years: 1.6 mg/kg/dose once daily for 5 to 10 days; maximum dose: 100 mg/dose.
CrCl <10 mL/minute/1.73 m2 (not on intermittent hemodialysis [HD] or continuous renal replacement therapy [CRRT]):
29 to 30 days of life: 1 mg/kg/dose on day 1, followed by 0.15 mg/kg/dose once daily for a total of 5 to 10 days.
31 to 90 days of life: 1.3 mg/kg/dose on day 1, followed by 0.2 mg/kg/dose once daily for a total of 5 to 10 days.
91 to 180 days of life: 1.6 mg/kg/dose on day 1, followed by 0.25 mg/kg/dose once daily for a total of 5 to 10 days.
181 days of life through 5 years: 1.9 mg/kg/dose on day 1 (maximum dose day 1: 100 mg/dose), followed by 0.3 mg/kg/dose once daily for a total of 5 to 10 days; maximum dose: 15 mg/dose.
6 to 17 years: 1.6 mg/kg/dose on day 1 (maximum dose day 1: 100 mg/dose), followed by 0.25 mg/kg/dose once daily for a total of 5 to 10 days; maximum dose: 15 mg/dose.
Hemodialysis (intermittent) CrCl <10 mL/minute/1.73 m2:
29 to 30 days of life: 1 mg/kg/dose on day 1, followed by 1 mg/kg/dose given 2 hours after each HD session on dialysis days only.
31 to 90 days of life: 1.3 mg/kg/dose on day 1, followed by 1.3 mg/kg/dose given 2 hours after each HD session on dialysis days only.
91 to 180 days of life: 1.6 mg/kg/dose on day 1, followed by 1.6 mg/kg/dose given 2 hours after each HD session on dialysis days only.
181 days of life through 5 years: 1.9 mg/kg/dose on day 1, followed by 1.9 mg/kg/dose given 2 hours after each HD session on dialysis days only; maximum dose: 100 mg/dose.
6 to 17 years: 1.6 mg/kg/dose on day 1, followed by 1.6 mg/kg/dose given 2 hours after each HD session on dialysis days only; maximum dose: 100 mg/dose.
CRRT: Limited data exist. Estimate total clearance by calculating CRRT clearance (CLCRRT) depending on CRRT modality used (eg, CVVHD, slow continuous ultrafiltration [SCUF]), plus any residual renal function, and adjust dosage according to CrCl recommendation.
Adolescents ≥18 years: Note: Dosage adjustment based on renal function estimated using the Cockcroft-Gault formula.
CrCl ≥50 mL/minute: No adjustment necessary.
CrCl 31 to 49 mL/minute: 150 mg once daily for 5 to 10 days.
CrCl 10 to 30 mL/minute: 100 mg once daily for 5 to 10 days.
CrCl <10 mL/minute (not on renal replacement therapy): 100 mg on day 1, followed by 15 mg once daily for 5 to 10 days.
Hemodialysis (HD): 100 mg on day 1, followed by 100 mg given 2 hours after each HD session on dialysis days only.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, not significantly metabolized hepatically.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
As reported with adult patients, unless otherwise noted.
1% to 10%:
Cardiovascular: Hypertension (2%)
Endocrine & metabolic: Increased serum glucose (>160 mg/dL: 5%)
Gastrointestinal: Constipation (4%), diarrhea (8%), vomiting (children & adolescents: 3%)
Genitourinary: Proteinuria (children & adolescents: 3%)
Hematologic and oncologic: Neutropenia (<1 x 109/L: 8%)
Hepatic: Increased serum alanine aminotransferase (>2.5 x ULN: 3%), increased serum aspartate aminotransferase (3%)
Nervous system: Insomnia (3%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (≥6 x ULN: 4%)
Postmarketing:
Dermatologic: Erythema multiforme, exfoliative dermatitis, skin rash, Stevens-Johnson syndrome
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
Nervous system: Abnormal behavior, delirium, hallucination
Serious hypersensitivity or anaphylaxis to peramivir or any component of the formulation.
Concerns related to adverse effects:
• Dermatologic reactions: Rare serious skin reactions (eg, erythema multiforme, Stevens-Johnson syndrome) have been reported. If skin reactions are suspected or occur, discontinue infusion immediately and institute appropriate supportive treatment.
• Hypersensitivity reactions: Serious hypersensitivity reactions (eg, anaphylaxis) have been reported. Discontinue infusion immediately and institute appropriate supportive treatment.
• Neuropsychiatric events: Rare occurrences of neuropsychiatric events (including abnormal behavior, delirium, and hallucinations), including fatalities have been reported, primarily among pediatric patients. Onset is often abrupt and subsequent resolution is rapid. These events may occur in patients with encephalitis, encephalopathy, or in uncomplicated influenza. Closely monitor for signs of abnormal behavior.
Disease-related concerns:
• Renal impairment: Elimination is primarily renal; dosage adjustment is required in patients with CrCl <50 mL/minute.
Other warnings/precautions:
• Appropriate use: Emergence of resistance substitutions or other factors (eg, viral virulence) could decrease drug effectiveness. Consider available information on influenza drug susceptibility patterns/treatment effects when using; efficacy in patients with serious influenza requiring hospitalization has not been established. Has not been shown to prevent secondary serious bacterial infections occurring during influenza course; if bacterial infections occur, treat with antibiotics as appropriate.
In pediatric trials, most frequently reported adverse effects included diarrhea and abnormal behavior (Komeda 2015). Abnormal behavior, particularly of a moderate severity, may be more likely with peramivir as compared to other neuraminidase inhibitors in patients 5 to 19 years of age; data are limited (Nakamura 2015; Sugawara 2020).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Rapivab: 200 mg/20 mL (20 mL)
No
Solution (Rapivab Intravenous)
200 mg/20 mL (per mL): $19.00
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Rapivab: 200 mg/20 mL (20 mL)
IV: Administer as an IV infusion over 15 to 30 minutes.
Parenteral: IV: For IV use only, do not administer IM. Administer diluted dose IV over 15 to 30 minutes; in some pediatric studies, infusion times up to 60 minutes have been used (Komeda 2015; Sugaya 2012).
Influenza, acute uncomplicated: Treatment of acute, uncomplicated influenza in patients ≥6 months of age who have been symptomatic ≤2 days.
Limitations of use: Efficacy is based on clinical trials in which influenza A was the predominant virus; a limited number of subjects with influenza B have been studied.
Influenza, hospitalized patients
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid administration of live influenza virus vaccine (LAIV) within 2 weeks before or 48 hours after administration of antiviral agents. Consider avoiding LAIV if peramivir was given within the last 5 days or baloxavir was given within the last 17 days. Risk D: Consider therapy modification
Information related to the use of peramivir for the treatment of influenza in pregnancy is limited (Hernandez 2011; Komeda 2016; Sorbello 2012). However, pregnant and postpartum patients (≤2 weeks after delivery) have a higher risk for complications from influenza, including preterm delivery, pneumonia, admission to a hospital or intensive care unit, and maternal and fetal death. Underlying maternal medical conditions increase these risks (ACOG 2018; CDC 2020a).
Based on information from one case, the pharmacokinetics of peramivir may be changed with pregnancy (Clay 2011).
Peramivir is not the preferred neuraminidase inhibitor for the treatment of influenza during pregnancy, however it may be used as an alternative agent when otherwise appropriate (ACOG 2018; CDC 2020a; CDC 2020b). Pregnant patients with known or suspected influenza can be treated with antiviral medications, regardless of trimester, vaccination status, or laboratory test results (ACOG 2018; CDC 2020a; CDC 2020b).
An algorithm is available for the treatment of pregnant patients with known or suspected influenza (ACOG 2018). Refer to the Centers for Disease Control and Prevention recommendations recommendations for treatment updates based on resistance patterns (ACOG 2018; CDC 2020a).
It is not known if peramivir is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Until additional information becomes available, peramivir is not the preferred neuraminidase inhibitor for the treatment of influenza in patients who are breastfeeding. Infectious patients should take precautions to avoid influenza transmission to the breastfed infant (CDC 2021a).
Baseline BUN and serum creatinine, neurologic abnormalities (eg, abnormal behavior), rash after administration.
Peramivir, a cyclopentane analogue, selectively inhibits the influenza virus neuraminidase enzyme, preventing the release of viral particles from infected cells.
Distribution: Vd: 12.56 L
Protein binding: <30%
Metabolism: Not significantly metabolized
Bioavailability: Oral: Low (investigational agent) (Hata 2014)
Half-life elimination: ~20 hours
Excretion: Urine (~90% as unchanged drug)
Altered kidney function: AUC increased with increasing degree of renal impairment.
Pediatric: Pharmacokinetics in children 2 to 17 years of age with uncomplicated influenza were similar to adults. In infants and children 6 months to <2 years of age, maximum concentration and initial 3-hour exposure were lower than in healthy adults, but the difference is not considered clinically significant (manufacturer's labeling). Critically ill children may demonstrate increased clearance and shorter elimination half-life as compared to children with uncomplicated influenza (Cies 2019).
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