Peramivir

Peramivir may be found in some form under the following brand names:

• Rapivab

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of peramivir, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Peramivir falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have

The recommended dose of peramivir for the treatment of the flu is 600 mg administered by IV infusion over 15 minutes within 2 days of the onset of flu symptoms.

Avoid getting the nasal flu vaccine (FluMist) within 48 hours after you are treated with peramivir, unless your doctor tells you to.

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

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• BCX-1812
• RWJ-270201

Influenza: Treatment of acute, uncomplicated influenza in adults who have been symptomatic ≤2 days.

Limitations of use:

Efficacy has not been established for patients with serious influenza requiring hospitalization.

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.

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

Dilute solution in D5W, NS, ½ NS, or LR to a maximum volume of 100 mL; administer immediately. If refrigerated, allow diluted solution to reach room temperature then administer immediately.

1% to 10%:

Cardiovascular: Hypertension (2%)

Central nervous system: Insomnia (3%)

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

Gastrointestinal: Diarrhea (8%), constipation (4%)

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%)

<1% (Limited to important or life-threatening): Abnormal behavior, anaphylactoid reaction, anaphylaxis, delirium, erythema multiforme, exfoliative dermatitis, hallucination, skin rash, Stevens-Johnson syndrome

Use is recommended only if clearly needed and the benefit outweighs the risk. US FDA pregnancy category: C

Animal studies have shown that this drug crosses the placenta and can cause both maternal and developmental toxicity. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.