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Peramivir

Medically reviewed on August 12, 2018

Pronunciation

(pe RA mi veer)

Index Terms

  • BCX-1812
  • RWJ-270201

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Rapivab: 200 mg/20 mL (20 mL)

Brand Names: U.S.

  • Rapivab

Pharmacologic Category

  • Antiviral Agent
  • Neuraminidase Inhibitor

Pharmacology

Peramivir, a cyclopentane analogue, selectively inhibits the influenza virus neuraminidase enzyme, preventing the release of viral particles from infected cells.

Distribution

Vd: 12.45 L

Metabolism

Not significantly metabolized

Excretion

Urine (~90% as unchanged drug)

Half-Life Elimination

~20 hours

Protein Binding

<30%

Special Populations: Renal Function Impairment

AUC increased with increasing degree of renal impairment

Use: Labeled Indications

Influenza: Treatment of acute, uncomplicated influenza in patients ≥2 years 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.

Off Label Uses

Influenza (hospitalized, high-risk patients)

Data from a multicenter, double-blind study conducted in Japan suggest that daily dosing of peramivir compared to a single dose may be beneficial (shorter duration of illness) in high-risk hospitalized patients with influenza A or B and moderate to severe symptoms [Kohno 2011]. During an open-label, randomized study of similar patients with 2009 influenza A (H1N1) in the United States, the use of peramivir was associated with decreases in viral shedding [Ison 2014]. However, in a subsequent randomized, placebo-controlled, multicenter, multinational trial in patients with influenza and severity of illness requiring hospitalization, the use of peramivir was not associated with decreases in viral shedding and clinical improvement and was terminated for futility due to sample size [de Jong 2014]. Additional data may be necessary to further define the role of daily peramivir in hospitalized high-risk patients.

Contraindications

Serious hypersensitivity or anaphylaxis to peramivir or any component of the formulation.

Dosing: Adult

Influenza (acute, uncomplicated): IV: 600 mg as a single dose; initiate within 2 days of onset of symptoms of influenza

Influenza (hospitalized, high-risk) (off-label use): IV: 600 mg once daily for up to 5 to 10 days (de Jong 2014; Ison 2014; Kohno 2011).

Note: During the 2009 influenza season, peramivir was given as part of an Emergency Use Authorization in the US for patients with pandemic A (H1N1) 2009 virus at a daily dose of 600 mg for a median duration of 6 days (Yu 2012). Subsequently, the drug has been studied but not approved for use in hospitalized patients and/or patients with complicated influenza because a clinical benefit could not be demonstrated (de Jong 2014). Some clinicians, however, may consider its use in this population, particularly in patients unable to tolerate or absorb oral oseltamivir (Yeh 2017; Yoo 2015; Zachary 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Influenza: IV: Note: Administer within 2 days of onset of symptoms of influenza.

Children: 2 to 12 years: 12 mg/kg as a single dose; maximum dose: 600 mg.

Adolescents ≥13 years: Refer to adult dosing.

Dosing: Renal Impairment

Note: Renal function may be estimated using the Cockcroft-Gault formula.

Adolescents ≥13 years of age and Adults:

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 (high-risk) 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)

Children 2 to 12 years of age:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute: 4 mg/kg as a single dose (maximum single dose: 200 mg)

CrCl 10 to 29 mL/minute: 2 mg/kg as a single dose (maximum single dose: 100 mg)

ESRD requiring hemodialysis: 2 mg/kg as a single dose, administered after dialysis (maximum single dose: 100 mg)

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, not significantly metabolized hepatically.

Reconstitution

Dilute solution in D5W, NS, 1/2NS, or LR to a maximum volume of 100 mL; administer immediately. If refrigerated, allow diluted solution to reach room temperature then administer immediately.

Administration

IV: Administer as an IV infusion over 15 to 30 minutes.

Storage

Store intact vials in original carton at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). After dilution, administer immediately or store at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Discard unused diluted solution after 24 hours.

Drug Interactions

Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid anti-influenza antivirals during the period beginning 48 hours prior to and ending 2 weeks after vaccine administration. Persons receiving these agents within 2 weeks of the live intranasal spray vaccine should receive a repeat vaccine dose. Consider therapy modification

Adverse Reactions

1% to 10%:

Cardiovascular: Hypertension (2%)

Central nervous system: Insomnia (3%)

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

Gastrointestinal: Diarrhea (8%), constipation (4%), vomiting (children & adolescents: 3%)

Genitourinary: Proteinuria (children & adolescents: 3%)

Hematologic and oncologic: Neutropenia (<1 x 109/L: 8%)

Hepatic: Increased serum ALT (>2.5 x ULN: 3%), increased serum AST (3%)

Neuromuscular & skeletal: Increased creatine phosphokinase (≥6 x ULN: 4%)

Miscellaneous: Fever (children & adolescents: 2%)

<1%, postmarketing, and/or case reports: Abnormal behavior, anaphylactoid reaction, anaphylaxis, delirium, erythema multiforme, exfoliative dermatitis, hallucination, skin rash, Stevens-Johnson syndrome

Warnings/Precautions

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

Monitoring Parameters

Baseline BUN and serum creatinine, neurologic abnormalities (eg, abnormal behavior), rash after administration.

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Information related to the use of peramivir in pregnancy is limited (Hernandez 2011; Sorbello 2012). Based on information from one case, the pharmacokinetics of peramivir may be changed with pregnancy (Clay 2011).

Untreated influenza infection is associated with an increased risk of adverse events to the fetus and an increased risk of complications or death to the mother (CDC 62[07], 2013). Neuraminidase inhibitors are currently recommended for the treatment or prophylaxis of influenza in pregnant women and women up to 2 weeks postpartum (CDC 60[1], 2011; CDC March 13, 2014; CDC January 2015).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), confusion, behavioral changes, altered speech, tremors, seizures, or hallucinations (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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