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Rapivab

Generic Name: Peramivir
Class: Neuraminidase Inhibitors
VA Class: AM800
Chemical Name: 3-[(1S)-1-(Acetylamino)-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2-hydroxy-cyclopentanecarboxylic acid hydrate
Molecular Formula: C15H28N4O4 • 3H2O
CAS Number: 1041434-82-5

Introduction

Antiviral; neuraminidase inhibitor.1 2 3 137 144

Uses for Rapivab

Treatment of Seasonal Influenza A and B Virus Infections

Treatment of acute, uncomplicated illness caused by influenza A or B viruses in adults ≥18 years of age.1 2 3 137

Although efficacy and safety not established in pediatric patients,1 has been used for treatment of influenza in infants and children.1 5 9 (See Pediatric Use under Cautions.)

CDC, US Public Health Service Advisory Committee on Immunization Practices (ACIP), and AAP recommend antiviral treatment of seasonal influenza illness initiated as soon as possible in all individuals with suspected or confirmed influenza who require hospitalization or have severe, complicated, or progressive illness (regardless of vaccination status or underlying illness).105 112 137 144 Early empiric antiviral treatment also recommended in individuals with suspected or confirmed influenza of any severity if they are at high risk of developing influenza-related complications because of age or underlying medical conditions.112 137 144 This includes children <2 years of age, adults ≥65 years of age, individuals of any age with certain chronic medical or immunosuppressive conditions, women who are pregnant or up to 2 weeks postpartum, individuals <19 years of age receiving long-term aspirin therapy, American Indians, Alaskan natives, morbidly obese individuals with body mass index (BMI) ≥40, and residents of any age in nursing homes or other long-term care facilities.112 137 144

CDC, ACIP, and AAP also state empiric antiviral treatment can be considered in previously healthy, symptomatic individuals with suspected or confirmed influenza who are not known to be at increased risk of developing severe or complicated illness if such treatment can be initiated within 48 hours of illness onset.105 112 137 144 Although these individuals typically do not require treatment, early empiric antiviral treatment might provide some benefit (e.g., decreased duration of illness).144

If indicated, initiate antiviral treatment as soon as possible after illness onset (ideally within 48 hours);112 137 144 177 do not delay initiation of treatment while waiting for laboratory confirmation.112 137 144 177

Although manufacturer states use for treatment of influenza only in patients who have been symptomatic for ≤2 days since efficacy not established in those whose symptoms have been present for >48 hours,1 there is some evidence from observational studies evaluating oseltamivir in hospitalized patients that antiviral treatment might still be beneficial when initiated up to 4 or 5 days after illness onset.112 137 144 177 CDC, ACIP, and AAP recommend that antiviral treatment be initiated in all patients with severe, complicated, or progressive illness attributable to influenza and all hospitalized patients and patients at increased risk of influenza complications (either hospitalized or outpatient) who have suspected or confirmed influenza, even if it has been >48 hours since illness onset.112 137 177 Base decisions regarding use of empiric antiviral treatment in outpatients, especially high-risk patients, on disease severity and progression, age, underlying medical conditions, likelihood of influenza, and time since onset of symptoms.137 177 If empiric antiviral treatment considered warranted in previously healthy, symptomatic outpatients not considered at increased risk of influenza complications, initiate within 48 hours after illness onset,112 137 177 but some experts state treatment can be considered in such patients even if it has been >48 hours since illness onset.112

When treatment of suspected or confirmed acute, uncomplicated seasonal influenza indicated, use age-appropriate antiviral (oral oseltamivir, IV peramivir, intranasal zanamivir).112 137 144 177 Oseltamivir usually preferred for hospitalized patients and patients with severe or complicated influenza since data lacking regarding use of peramivir or zanamivir in such patients.112 137 161 Although manufacturer states efficacy of peramivir for treatment of influenza in hospitalized patients not established,1 CDC states that peramivir may be considered for treatment of hospitalized patients with severe influenza who cannot tolerate or absorb oseltamivir (e.g., because of suspected or known gastric stasis, malabsorption, or GI bleeding).137 161

Consider viral surveillance data available from local and state health departments and CDC when selecting an antiviral for treatment of seasonal influenza.1 137 144 Strains of circulating influenza viruses and the antiviral susceptibility of these strains constantly evolve;1 144 emergence of peramivir-resistant strains may decrease effectiveness of the drug.1 Although influenza A and B viruses circulating in US during last few years generally have been susceptible to peramivir,559 561 562 consult most recent information.1 137 144

CDC issues recommendations concerning use of antivirals for treatment of influenza, and these recommendations are updated as needed during each influenza season.137 144 Information regarding influenza surveillance and updated recommendations for treatment of seasonal influenza are available from CDC at .

Avian Influenza A Virus Infections

Alternative for treatment of infections caused by susceptible avian influenza A viruses.50 178 556

For treatment of severe, complicated, or progressive avian influenza A infections in hospitalized patients or outpatients, including infections caused by highly pathogenic Asian strain of influenza A (H5N1), other highly pathogenic avian influenza (HPAI) H5 strains, or novel avian influenza A (H7N9), CDC and WHO recommend oseltamivir as drug of choice.104 178 CDC states peramivir may be considered for treatment of hospitalized patients with severe avian influenza A infection who cannot tolerate or absorb oseltamivir (e.g., because of suspected or known gastric stasis, malabsorption, or GI bleeding).178

For treatment of uncomplicated avian influenza A infections in outpatients, CDC states oseltamivir, zanamivir, or peramivir may be used.178

When antiviral prophylaxis indicated in close contacts of individuals with confirmed or probable infection with avian influenza A virus, CDC recommends oseltamivir or zanamivir.179

Most recent information regarding treatment and prevention of avian influenza A infections is available from CDC at or WHO at .

Pandemic Influenza

Alternative for treatment of pandemic influenza caused by susceptible strains of influenza virus.5 9 52 151

Influenza viruses can cause pandemics, during which rates of illness and death from influenza-related complications can increase dramatically worldwide.52 488

Most recent influenza pandemic occurred during 2009 and was related to a novel influenza A (H1N1) strain, influenza A (H1N1)pdm09.52 134 144 151 488 In the US, the pandemic was characterized by a substantial increase in influenza activity that peaked in late October and early November 2009 and returned to seasonal baseline levels by January 2010.123 488 During that time, ≥99% of influenza viruses circulating in the US were influenza A (H1N1)pdm09.123 488 In August 2010, the WHO declared that the world was in a post-pandemic period;148 since that time, influenza A (H1N1)pdm09 has become a seasonal influenza virus and continues to circulate with other seasonal viruses.144 551 553 561 562

The spread of the highly pathogenic Asian strain of avian influenza A (H5N1) in poultry in Asia and other countries that has been occurring since 2003 and has caused human infections represents a potential future pandemic threat.50 52 54 55 56 104 147 The novel avian influenza A (H7N9) virus first identified in China in March 2013 that has been causing sporadic human infections also has pandemic potential.50 104 182 555 556

Rapivab Dosage and Administration

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.1

Commercially available injection containing 10 mg/mL must be diluted prior to administration.1

Do not mix with or administer simultaneously with other drugs.1

Compatible with materials commonly used for administration (e.g., polyvinyl chloride and polyvinyl chloride-free infusion bags, polypropylene syringes, polyethylene tubing).1

Vials contain no preservatives or bacteriostatic agents and are for single use only.1

Dilution

Withdraw appropriate dose of peramivir injection containing 10 mg/mL and dilute in 0.9 or 0.45% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection to achieve a maximum total volume of 100 mL.1

Administer immediately after dilution.1 If not used immediately, diluted solution may be stored for ≤24 hours at 2–8°C.1 Allow refrigerated solution to reach room temperature and administer immediately.1

Discard unused portions of diluted solution 24 hours after dilution.1

Rate of Administration

Administer by IV infusion over 15–30 minutes.1

Dosage

Adults

Treatment of Seasonal Influenza A and B Virus Infections
Treatment of Acute, Uncomplicated Seasonal Influenza A or B Virus Infections
IV

Single 600-mg dose given within 2 days of symptom onset.1

Special Populations

Hepatic Impairment

Not studied in patients with hepatic impairment;1 clinically important alterations in pharmacokinetics not expected.1

Renal Impairment

Clcr ≥50 mL/minute: Usual dosage.1

Clcr 30–49 mL/minute: Single 200-mg dose.1

Clcr 10–29 mL/minute: Single 100-mg dose.1

Chronic renal disease maintained on hemodialysis: Adjust dosage based on renal function;1 give dose after dialysis.1

Geriatric Patients

Dosage adjustments based solely on age not needed.1

Cautions for Rapivab

Contraindications

  • Manufacturer states none.1

Warnings/Precautions

Sensitivity Reactions

Dermatologic and Hypersensitivity Reactions

Serious dermatologic reactions (Stevens-Johnson syndrome, erythema multiforme) reported.1 Exfoliative dermatitis and rash also reported.1

If hypersensitivity or serious skin reaction occurs or is suspected, initiate appropriate treatment.1

Neuropsychiatric and CNS Effects

Postmarketing cases of delirium and abnormal behavior leading to injury reported in patients with influenza receiving neuraminidase inhibitors, including peramivir.1 Most cases involved children in Japan and generally had abrupt onset and rapid resolution.1 Role of peramivir not established.1

Influenza itself can be associated with a variety of neurologic and behavioral symptoms (e.g., hallucinations, delirium, abnormal behavior) and fatalities can occur.1 Although such events may occur in the setting of encephalitis or encephalopathy, they can occur without obvious severe disease.1

Closely monitor patients with influenza for signs of abnormal behavior.1

Differential Diagnosis

When making treatment decisions in patients with suspected influenza, consider possibility of primary or concomitant bacterial infection for which peramivir would be ineffective.1

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications of influenza.1 No evidence that peramivir prevents such complications.1

No evidence of efficacy in illness caused by any organisms other than influenza A or B.1

Influenza Vaccination

Although antivirals used for treatment of influenza, including peramivir, may be used concomitantly with or at any time before or after influenza virus vaccine inactivated,1 100 these antivirals may inhibit the vaccine virus contained in influenza vaccine live intranasal.1 100 (See Specific Drugs under Interactions.)

Specific Populations

Pregnancy

Category C.1

No adequate and well-controlled studies using peramivir in pregnant women;1 animal studies revealed evidence of maternal toxicity, developmental toxicity, and some fetal anomalies.1

Pregnant women are at increased risk for severe complications from influenza,142 144 which may lead to adverse pregnancy and/or fetal outcomes including maternal death, stillbirths, birth defects, preterm delivery, low birthweight, and small size for gestational age.21

Manufacturer states use peramivir during pregnancy only if clearly needed.1

CDC and ACIP state that pregnancy is not a contraindication to use of antivirals for treatment of influenza;137 142 144 oseltamivir may be preferred when a neuraminidase inhibitor indicated for treatment of influenza in women who are pregnant or up to 2 weeks postpartum.137 142 144

Lactation

Distributed into milk in rats;1 not known whether distributed into human milk.1

Consider benefits of breast-feeding and importance of peramivir to the woman; also consider potential adverse effects on the breast-fed child from the drug or underlying maternal condition.1

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.1

During the 2009 influenza A (H1N1)pdm09 pandemic (see Pandemic Influenza under Uses), FDA issued an Emergency Use Authorization (EUA) that temporarily allowed use of peramivir for treatment of serious pandemic influenza virus infection in certain hospitalized patients, including infants and children.10 11 Although the EUA expired in June 2010,11 some information is available regarding safety and efficacy for treatment of influenza virus infection in pediatric patients.1 5 9 Data from an open-label study evaluating peramivir for treatment of uncomplicated influenza in infants and children 4 weeks to 16 years of age indicated that the safety profile is similar to that reported in adults.5 Most frequently reported adverse effects in pediatric patients are GI effects (diarrhea, vomiting) and decreased neutrophil counts.1 5 9

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Hepatic Impairment

Not studied in patients with hepatic impairment;1 clinically important alterations in pharmacokinetics not expected since the drug does not undergo clinically important metabolism.1 (See Elimination under Pharmacokinetics.)

Renal Impairment

Increased AUC.1 Reduce dosage in adults with Clcr <50 mL/minute.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea,1 constipation,1 insomnia,1 hypertension.1

Interactions for Rapivab

Not metabolized by and does not affect CYP isoenzymes.1 Drug interactions with drugs that are substrates or inhibitors of these enzymes unlikely.1

Not a substrate for and does not inhibit P-glycoprotein (P-gp).1

Specific Drugs

Drug

Interaction

Comments

Estrogens/progestins

Oral contraceptives containing ethinyl estradiol and levonorgestrel: No interactions1

Influenza virus vaccines

Influenza virus vaccine inactivated: No specific studies1

Influenza vaccine live intranasal: Peramivir may inhibit the vaccine virus;1 100 no specific studies1

Influenza virus vaccine inactivated: May be administered simultaneously with or at any time before or after peramivir1 100

Influenza vaccine live intranasal: Do not administer the live vaccine until at least 48 hours after peramivir discontinued;1 100 do not administer peramivir until at least 2 weeks after the vaccine, unless medically necessary;1 if peramivir is administered within 2 weeks after the vaccine, ACIP recommends revaccination ≥48 hours after antiviral dose;100 alternatively, if peramivir given 2 days before to 14 days after the vaccine, revaccinate using parenteral inactivated vaccine or parenteral recombinant vaccine100

Oseltamivir

No interactions1

Probenecid

No interactions1

Rimantadine

No interactions1

Rapivab Pharmacokinetics

Absorption

Bioavailability

Following IV infusion over 30 minutes, peak serum concentrations attained at end of the infusion.1 Negligible accumulation following multiple doses for up to 10 days.1

Linear relationship between dose and exposure parameters (peak plasma concentrations, AUC).1

Distribution

Extent

Well distributed within extracellular fluid spaces, including nose and throat, following IV administration.6

Crosses placenta in animals.1

Distributed into milk in rats;1 not known whether distributed into human milk.1

Plasma Protein Binding

<30%.1

Elimination

Metabolism

Does not undergo clinically important metabolism.1

Not a substrate for and does not affect CYP isoenzymes.1

Elimination Route

Following IV administration, approximately 90% of dose eliminated unchanged in urine, principally by glomerular filtration.1

Removed by hemodialysis.1

Half-life

Approximately 20 hours following single 600-mg IV dose.1

Special Populations

Renal Impairment: AUC increased by 28, 302, or 412% in patients with Clcr of 50–79, 30–49, or <30 mL/minute, respectively, compared with individuals with normal renal function.1 Systemic exposure decreased by 73–81% in patients undergoing hemodialysis.1

Hepatic impairment: Pharmacokinetics not studied, but substantial alterations not expected since the drug does not undergo clinically important metabolism.1

Geriatric individuals: Pharmacokinetics similar to that in younger adults.1

Stability

Storage

Parenteral

Solution for IV Use

20–25°C (may be exposed to 15–30°C).1

Following dilution, use immediately or store for ≤24 hours at 2–8°C.1 Discard unused portions 24 hours after dilution.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1

Compatible

Dextrose 5%

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Actions and Spectrum

  • Peramivir is a potent selective competitive inhibitor of influenza virus neuraminidase, an enzyme essential for viral replication; possibly alters virus particle aggregation and release.1 2 3 6 9

  • Active in vitro against both influenza A and B viruses.1 2 3 6 137 Majority of seasonal influenza A (H3N2), influenza A (H1N1)pdm09, and influenza B viruses circulating during recent influenza seasons have been susceptible to neuraminidase inhibitors (oseltamivir, peramivir, zanamivir) in vitro;551 552 557 559 561 562 resistance reported rarely.123 144 163 167 551 552 557 559 561 562

  • Active against some avian influenza A viruses, including some strains of avian influenza A (H5N1) and (H7N9).6 181

  • Influenza viruses with decreased susceptibility to peramivir have been produced in vitro and observed rarely in clinical isolates.1 181 6 Clinical importance of decreased in vitro susceptibility not known.1

  • Cross-resistance between peramivir and other neuraminidase inhibitors (e.g., oseltamivir, zanamivir) reported in influenza A and B viruses.1 6 21 172 173 175 181 However, because oseltamivir, peramivir, and zanamivir bind to different sites on the neuraminidase enzyme or interact differently with binding sites, cross-resistance among the drugs is variable.173 175 Some influenza A or B strains have reduced in vitro susceptibility to peramivir and/or oseltamivir, but are susceptible to zanamivir;1 144 163 167 181 552 562 other strains have reduced in vitro susceptibility to zanamivir, but are susceptible to peramivir and/or oseltamivir.1 21 181 562 Reduced in vitro susceptibility to all 3 drugs (oseltamivir, peramivir, zanamivir) reported in some influenza A and B strains with certain resistance-associated neuraminidase substitutions.1 21 562 To date, influenza A (H1N1)pdm09 isolates with the H275Y mutation are cross-resistant to oseltamivir and peramivir, but susceptible to zanamivir in vitro.172 174 181 559 562

Advice to Patients

  • Advise patients of the risk of serious skin reactions and importance of immediately contacting a clinician if a skin reaction occurs.1

  • Advise patients of the risk of neuropsychiatric reactions in patients with influenza and importance of immediately contacting a clinician if they experience signs of abnormal behavior after receiving peramivir.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Peramivir

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

10 mg/mL

Rapivab

BioCryst

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.

References

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