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Influenza
Burden

The clinical impact of influenza

Influenza affects a large number of people in the United States every year; during the 2015-2016 flu season, there were an estimated 25 million cases of influenza. Over 2 million children under the age of 5 years were among those who suffered the flu. Since 2010, CDC estimates that flu-related hospitalizations among children younger than 5 years ranged from 7,000 to 26,000 in the United States. Even children in this age group who are otherwise healthy are at risk simply because of their age.1-4

Additionally, children 2 years of age up to their 5th birthday are more likely than healthy older children to be taken to a doctor, an urgent care center, or the emergency room because of flu. It strains the health care system and puts many patients in jeopardy, especially those who are at greater risk for serious complications.1-4

Influenza illness–related direct medical costs, work absenteeism, and lost income (even in patients with mild disease) may result in a significant economic burden on society.2

Influenza is one of the most common and important respiratory illnesses affecting people of all ages.2

Influenza infects approximately 10% to 15% of the US population every year.2

 

Influenza is a significant burden for patients and health care professionals

 

Do you see at-risk patients?

These populations can be at risk for complications from influenza2,a:

Adults 65 years and older
and children, especially
younger than 5 years4,b

Adults and children
with concurrent illness

Patients with
weakened immune system

aThe populations noted here are found in the general public and recognized by the CDC. Rapivab is indicated for patients 2 years and older.
 No substantive data exist on the use of Rapivab in adults or children with concurrent illness or with weakened immune system.

bRapivab is indicated in patients 2 years and older.

Many conditions can increase the risk of serious complications5

The CDC has identified these concomitant conditions that may put patients at greater risk of complications from influenza.

    • Asthma

    • Chronic lung disease

      (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis)

    • Heart disease

      (e.g., congenital heart disease, congestive heart failure, coronary heart disease)

    • Endocrine disorders

      (e.g., diabetes mellitus)

    • Metabolic disorders

      (e.g., inherited metabolic disorders, mitochondrial disorders)

    • Kidney disorders

      (e.g., chronic kidney disease, moderate to severe renal disease)6

    •  
    • Liver disorders

      (e.g., hepatitis, chronic liver disease, cirrhosis)6

    • Neurological and neurodevelopmental conditions

      (e.g., cerebral palsy, epilepsy, stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)

    • Extreme obesity

      (with a body mass index of 40 or higher)

    • Blood disorders

      (e.g., sickle cell disease)

 

CDC recommendations — treat early and quickly

The CDC has issued recommendations for the treatment of patients with influenza:

Clinical benefit is greatest when antiviral influenza treatment is administered early, especially within 48 hours of influenza illness onset.7
When indicated, antiviral influenza treatment should be started as soon as possible after illness onset and should not be delayed even for a few hours to wait for the results of testing.7
Initiate antiviral influenza treatment in patients with risk factors for influenza complications, such as asthma and heart disease.7
References: 1. Estimated influenza illness, medical visits, hospitalizations, and deaths averted by vaccinations in the United States. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/disease/2015-16.htm#table3. Updated April 19, 2017. Accessed September 15, 2017. 2. Clark NM, Lynch JP III. Influenza: epidemiology, clinical features, therapy, and prevention. Semin Respir Crit Care Med. 2011;32(4):373-392. 3. People at high risk of developing flu-related complications. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/about/disease/high_risk.htm. Updated August 25, 2016. Accessed February 1, 2017. 4. Children, the flu, and the flu vaccine. https://www.cdc.gov/flu/protect/children.htm. Updated May 10, 2017. Accessed September 15, 2017. 5. Annunziata K, Rak A, Buono HD, DiBonaventura M, Krishnarajah G, Xu J. Vaccination rates among the general adult population and high-risk groups in the United States. PLoS One. 2012;7(11):1-9. 6. CDC health update regarding treatment of patients with influenza with antiviral medications. http://emergency.cdc.gov/han/han00375.asp. Updated January 9, 2015. Accessed October 5, 2015. 7. What you should know about influenza (flu) antiviral drugs. Centers for Disease Control and Prevention website. http://www.cdc.gov/flu/pdf/freeresources/updated/antiviral_factsheet1112_9-24.pdf. Updated August 16, 2016. Accessed September 16, 2016.
Important Safety Information  

RAPIVAB® (peramivir injection) Important Safety Information

Indication

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.

Limitations of Use
  • Efficacy of RAPIVAB is 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. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB.

  • The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization.

Contraindications

RAPIVAB is contraindicated in patients with 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.

Warnings and Precautions
  • Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketing experience with RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to RAPIVAB.

  • Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. There have been postmarketing reports (from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including Rapivab. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatric patients. The contribution of Rapivab to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Rapivab has not been shown to prevent such complications.

Adverse Reactions

The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% Rapivab vs 7% placebo). Lab abnormalities (incidence ≥2%) occurring more commonly with Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 6%). In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).

The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults included vomiting (3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, respectively, for each of these events). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).

Concurrent Use with Live Attenuated Influenza Vaccine

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy). The concurrent use of Rapivab with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

Please see full prescribing information for Rapivab.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates.