Nirsevimab-alip to Prevent RSV Materials

NIRSEVIMAB-ALIP AS A NEW OPTION TO PREVENT RESPIRATORY SYNCYTIAL VIRUS

AMANDA MAYER, PharmD

Amanda Mayer is a graduate of the University of Montana, Skaggs School of Pharmacy. She has clinical experience as a pharmacist in the inpatient mental health setting, which is her passion. She has also done fill-in work at retail pharmacies throughout her career. Amanda appreciates the wide variety of professional opportunities available to pharmacists. Amanda loves spending time with her family and spends most of her free time exploring new restaurants, hiking in the summer, snowboarding, and cross-country skiing in the winter.

Topic Overview

Approximately 2 million children under the age of 5 will visit a healthcare provider in an outpatient setting because of an RSV infection. From this population group, the estimates are that between 58,000–80,000 will be hospitalized with RSV. The U.S. Food and Drug Administration (FDA) approved nirsevimab-alip (BEYFORTUS®) as a new RSV immunization to help prevent severe RSV in babies and toddlers. Nirsevimab-alip is indicated for neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. This immunization may be used as part of a prevention plan during the RSV season.

Accreditation Statement

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is 

Pharmacist  0669-0000-24-001-H06-P

Pharmacy Technician  0669-0000-24-002-H06-T

Credits: 1.5 contact hours (0.15 CEUs) of continuing education credit

Type of Activity: Knowledge

Media: Internet/Home study Fee Information: $5.99

Estimated time to complete activity: 1.5 contact hours (0.15 CEUs), including Course Test and course evaluation

Release Date: January 8, 2024 Expiration Date: January 8, 2027

Target Audience: This educational activity is for pharmacists.

How to Earn Credit: From January 8, 2024, through January 8, 2027, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “Educational Activity;” and,

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately (No partial credit will be given).

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Identify individuals who are at high risk of severe disease from the respiratory syncytial virus (RSV).

Discuss strategies to prevent RSV.

Identify individuals who are indicated to receive nirsevimab-alip.

Outline the dosing and administration guidelines for nirsevimab-alip.

Disclosures

The following individuals were involved in developing this activity: Amanda Mayer, PharmD, and Pamela Sardo, PharmD, BS. Pamela Sardo was an employee of Rhythm Pharmaceuticals until March 2022 and has no conflicts of interest or relationships regarding the subject matter discussed. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.

© RxCe.com LLC 2024: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.

Educational Activity

Nirsevimab-alip as a New Option to Prevent Respiratory Syncytial Virus

Introduction

Respiratory syncytial virus is a respiratory virus that typically presents with mild cold-like symptoms; however, some population groups are at increased risk of developing severe symptoms or dying from this virus. Children under five years of age are particularly at risk of severe illness, hospitalization, or death, driving the need for better preventive approaches for this age group. Nirsevimab-alip has been recently approved to prevent severe respiratory syncytial virus in infants and children under 24 months. This immunization may be used as part of a prevention plan during the viral season. This course reviews the prevalence and risk factors of the virus, its prevention (including immunization using nirsevimab-alip), symptom management, and the impact pharmacists and pharmacy staff may have in caring for pediatric patients at risk of severe respiratory syncytial virus symptoms.

Prevalence of Respiratory Syncytial Virus

Respiratory syncytial virus (RSV) is a common, seasonal respiratory virus.1 Respiratory syncytial virus season is typically in the fall and winter months.2 In the United States, RSV infection is associated with substantial morbidity in the hospital and outpatient settings.1

Approximately 2 million children under the age of 5 will visit a healthcare provider in an outpatient setting because of an RSV infection.1,2 From this population group, the estimates are that between 58,000–80,000 will be hospitalized with RSV.2-4 These rates of RSV-associated hospitalization in young children are substantially higher than hospitalization rates for the flu.3 These rates are highest during the first year of life, declining significantly in the second year, and almost disappearing by age three.3 The Centers for Disease Control and Prevention (CDC) states that almost all children will have

had an RSV infection by their second birthday.5 Feiler, et al. (2023) reported that of the ~ 70% of children who get RSV in their first year of life, 50% will have a recurrence in their second year of life.6 The number of young children who die from RSV is between 100–300.2,7,8

In the United States, RSV is also the leading cause of pneumonia and bronchiolitis in children <1 year old.5,6 This occurs when the RSV infection, which begins in the nasopharyngeal epithelium, travels through the lower airways and into the terminal bronchioles.9

Risk Factors for RSV

The risk of developing severe illness from RSV is greatest in the following groups:

Premature infants10

Infants up to 12 months (especially 6 months and younger)10

Younger than 2 years of age with chronic lung disease or congenital heart disease10

Children with weakened immune systems10

Children with neuromuscular disorders (including those with difficulty swallowing or clearing mucus secretions)10

Children diagnosed with asthma have a substantial risk for RSV, especially in the youngest children with asthma.3

Transmission of RSV

Respiratory syncytial virus can spread through droplets if an infected person coughs or sneezes into another person’s eyes, nose, or mouth (i.e., entering and infecting the nasopharyngeal airway or the conjunctival mucosa).9,11 Direct contact with the virus, such as kissing the face of a child, can also spread RSV. Touching a surface such as a doorknob, table, or crib, then touching your face before washing your hands may also spread the virus.11 The RSV virus can survive for up to 6 hours on hard surfaces, about 90 minutes on rubber gloves, and for about 20 minutes on the skin.9 This

highlights the need for people to wash their hands and use contact precautions to keep the infection from spreading, especially in clinic settings.9

The incubation period for RSV is between 2 to 8 days.9 Individuals with RSV may become contagious 1 to 2 days before displaying symptoms and are usually contagious for 3 to 8 days.9,11 Infants and some individuals with weakened immune systems may spread the virus typically for as long as 4 weeks.11 However, Piedimonte, et al. (2014), note that viral shedding from immunocompromised individuals can continue for several months.9 The virus can be spread by patients who are asymptomatic.11

RSV Symptoms and Their Management

Respiratory syncytial virus typically causes cold-like symptoms that are mild and self-limiting.5,12 These symptoms typically last one to two weeks.5 Individuals who are infected with RSV usually show symptoms within 4 to 6 days after getting infected. Symptoms may include runny nose, decreased appetite, coughing, sneezing, fever, and wheezing.5 In young infants, symptoms may present as irritability, decreased activity, and breathing difficulties. As stated above, RSV is the most common cause of bronchiolitis and pneumonia in children under 1 year of age, and symptoms of these conditions can appear in patients with RSV.3,5

Currently, antiviral medications are not routinely recommended to fight RSV infection. Managing fever and pain, drinking fluids, and talking to your healthcare provider prior to taking nonprescription medication are steps that are typically taken to help relieve symptoms of RSV.13 Patients with severe RSV may need to be hospitalized if they are having trouble breathing or are dehydrated. Hospitalized patients may require additional oxygen, IV fluids, or intubation with mechanical ventilation.13

Prevention of RSV

Everyday preventative measures to help limit the spread of RSV are the same measures used to prevent the spread of other respiratory illnesses.13 Individuals should stay home when they are sick. When coughing and sneezing, a tissue or shirt sleeve should be used to cover the mouth and nose instead of hands. Washing hands regularly for at least 20 seconds with soap and water can be a significant way to help limit the spread of illness.13 All individuals should avoid touching their faces with unwashed hands. Close contact with others, such as kissing, shaking hands, and sharing cups and eating utensils, should be avoided. Frequently touched surfaces such as doorknobs and mobile devices should be cleaned often.13

Most children infected with RSV were healthy, suggesting that control strategies targeting only high-risk children will have a limited effect on the total disease burden of RSV infection.1 A broader approach to prevention is needed, such as monoclonal antibody or vaccination.14,15

Palivizumab, a multiple-dose monoclonal antibody, was previously the only available immunoprophylaxis agent against severe RSV-related lower respiratory tract illness in premature and other high-risk infants.14 On July 17, 2023, the U.S. Food and Drug Administration (FDA) approved nirsevimab-alip (BEYFORTUS®) as a new RSV immunization to help prevent severe RSV in babies and toddlers.16 The prescribing information states that nirsevimab-alip is indicated for neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.15

In August 2023, the CDC recommended nirsevimab-alip to help protect babies and toddlers from severe RSV.16 The CDC recommends nirsevimab-alip as a single, longer-lasting dose for all infants aged 8 months and younger born during or entering their first RSV season and as a single dose for infants and children aged 8–19 months who are at increased risk for severe RSV disease and entering their second RSV season.16 Nirsevimab-alip is not indicated for use in females of reproductive potential.15

On September 22, 2023, a distinct maternal RSVpreF vaccine was recommended for pregnant women. Women who are 32-36 weeks pregnant during the months of September through January and who reside in the continental United States should receive the RSVpreF vaccine to prevent newborn babies from severe RSV.17,18 By administering the vaccine to the mother during these months, the infants will be at the highest level of protection during the RSV season and their first months of life.18 In jurisdictions outside the continental United States, the RSV season differs, so the months the RSVpreF vaccine should be administered are also different.18 These geographical areas include Alaska, southern Florida, Guam, Hawaii, Puerto Rico, U.S.-affiliated Pacific Islands, and the U.S. Virgin Islands.18 Providers should consult state, local, or territorial guidance on the timing of the RSVpreF vaccination.18 The CDC stated in the September 22, 2023, vaccine update that most infants will likely only need protection from either the maternal RSV vaccine or the RSV immunization for babies.17,18

In July 2023, the CDC recommended RSV vaccines for adults ages 60 and over if deemed appropriate by their healthcare provider.19,20 There are two RSV vaccines licensed by the FDA for use in adults 60 and older in the United States: RSVPreF3 (AREXVY®), and RSVpreF (ABRYSVO®).20

A final point to make in preventing serious illness from RSV is the need for a complete patient history and consideration of potential risk factors. For example, a missed asthma diagnosis can impact effective prevention of RSV and symptom management.3

Nirsevimab-alip

Nirsevimab-alip was approved by the FDA on July 17, 2023.15 Nirsevimab can be administered with other childhood immunizations. In addition, there is currently no known drug interaction between nirsevimab and any other drug.

Indications

Nirsevimab-alip is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering into their first RSV season AND children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.15 The American Academy of Pediatrics and the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends nirsevimab for all infants <8 months born during or entering their first RSV season and for children aged 8–19 months who are at increased risk for severe RSV disease and entering their second RSV season.8,21

Dosing and Administration

Table on Dosing and Administration

Mechanism of Action

Nirsevimab is a monoclonal antibody with anti-RSV activity. It is a recombinant IgG1ƙ monoclonal antibody. Nirsevimab targets the prefusion conformation of the RSV F protein to provide passive immunity. RSV is neutralized by the inhibition of the conformation changes in the F protein that are necessary for the fusion of the viral and cellular membranes and viral entry.15,22 The duration of protection extends through 5 months after a single dose of nirsevimab.15

Storage and Handling

Nirsevimab should be refrigerated between 36℉ and 46℉ for storage.15 It should be stored in the original carton to protect the medication from light until the time of use.15 Nirsevimab may be kept at a room temperature of 68℉ to 77℉ for a maximum of 8 hours. Once removed from the refrigerator, any pre-filled syringe must be used within 8 hours or discarded.15 Do not freeze,

Dosing considerations for the 2023-2024 RSV season with regard to palivizumab versus nirsevimab administration for high-risk infants:8

If nirsevimab has been administered, palivizumab should NOT be administered.

If palivizumab was administered initially for the season but less than

5 doses were administered, the infant should receive 1 dose of nirsevimab with no further palivizumab.

If palivizumab was administered in season 1 and the child is eligible for RSV prophylaxis in season 2, nirsevimab should be administered if available. If no nirsevimab is available, palivizumab should be administered as previously recommended.

The preferred IM administration site is the anterolateral aspect of the thigh. The gluteal muscle should not be used due to the risk of damage to the sciatic nerve.8,15

Must be administered by a healthcare provider.8,15

Based on pre-pandemic RSV infection patterns, nirsevimab may be administered in most of the United States from October through the end of March.8

shake, or expose the syringe to heat. Each pre-filled syringe is for one-time use only.15

Contraindications, Warnings, and Precautions

Contraindications to nirsevimab include infants and children with a history of serious hypersensitivity reactions to nirsevimab-alip.15 Nirsevimab should be given with caution to infants and children with thrombocytopenia, any coagulation disorder, or to individuals on anticoagulation therapy.15 The FDA labeling states that children who have received nirsevimab should not receive palivizumab for the same RSV season.21

Caregivers of children receiving nirsevimab should be informed of the signs and symptoms of a serious allergic reaction, which include the following:15

Swelling of the face, mouth, or tongue

Difficulty breathing or swallowing

Unresponsiveness

Bluish color of skin, lips, or under fingernails

Muscle weakness

Severe rash, hives, or itching

Adverse Reactions

Adverse reactions that were reported at a higher incidence than placebo included rash and injection site reactions during clinical trials.15 The reported rash occurred anywhere within 14 days post-dose, and the injection site reaction occurred within 7 days post-dose. Injection site reactions included pain, induration, edema, and swelling at the site.15

Drug Interactions

There are no known drug interactions currently listed by the manufacturer.15 Nirsevimab does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays. If an immunological assay result is negative when clinical observations are consistent with RSV infection, it is recommended to confirm results using an RT-PCR-based assay. Nirsevimab is not predicted to be a substrate, inhibitor, or inducer of cytochrome P450 enzymes or transporter systems.15

Special Populations

Nirsevimab is not indicated for use in females of reproductive potential.15 Pregnant women should consult with their providers as there are other options available for RSV prevention while pregnant. The safety and efficacy of nirsevimab have been established for the prevention of RSV in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who are at risk of developing severe RSV through their second RSV season.15

Overdosage

There is limited experience regarding nirsevimab overdose. There is no specific treatment; however, individuals should be monitored for adverse reactions and symptoms and should be treated when appropriate.15

Clinical Studies

The safety and efficacy of nirsevimab were evaluated in term and preterm infants in Phase 2 and Phase 3 clinical trials (Trials 03, 04, and 05).8,15 A total of 3,224 pediatric subjects received the recommended dose of BEYFORTUS.8,15 These trials were conducted to evaluate the prevention of medically attended RSV lower respiratory tract infection (MA RSV LRTI).15 Trial 03 studied infants born at ≥29 to <35 weeks gestational age entering their first RSV season.15 This trial had 969 individuals in the nirsevimab group and 484 individuals in the placebo group. All individuals in this trial received 50 mg of nirsevimab IM injections regardless of body weight.15 This was a randomized, double-blind, placebo-controlled multicenter trial with a primary endpoint being the incidence of MA RSV LRTI caused by RT-PCR–confirmed RSV. RSV was characterized predominantly as bronchiolitis or pneumonia through 150 days after nirsevimab dosing. The incidence of MA RSV LRTI in the nirsevimab group was 2.6% (25 individuals) and 9.5% (46 individuals) in the placebo group.15 The efficacy based on the relative risk reduction was 78.4% in this trial through 150 days post-dose of Beyfortus.15

Trial 04 was also a double-blind, placebo-controlled multicenter trial that looked at infants born at ≥35 weeks gestational age entering their first RSV season.23 This trial had a primary cohort with 994 individuals in the nirsevimab group and 496 individuals in the placebo group. In the safety cohort of this group, there were 1,015 individuals in the nirsevimab group and 507 individuals in the placebo group. The primary endpoint in this trial was the incidence of MA RSV LRTI caused by RT-PCR-confirmed RSV. In this trial, the incidence of MA RSV LRTI was 1.2% (12 individuals) in the nirsevimab group and 5.0% (25 individuals) in the placebo group through 150 days post-dose.23 The relative risk reduction in this trial was 60.2%, and dosing was done as described in the dosing section of the 50 mg IM for those less than 5 kg and 100 mg IM for those greater than or equal to 5 kg.15

Trial 05 was a randomized, double-blind, palivizumab-controlled multicenter trial that looked at infants born at <35 weeks gestational age and infants born with chronic lung disease (CLD) or hemodynamically significant

chronic heart disease (CHD) entering into their first RSV season and infants with CLD or CHD only entering their second RSV season.15 In the RSV season one group, there were 616 individuals in the nirsevimab group and 304 individuals in the palivizumab group. In the RSV Season Two group, there were 220 individuals in the nirsevimab group and 42 individuals in the palivizumab group. Individuals who received nirsevimab received 4 once- monthly placebo doses to keep the study blind, as the palivizumab administration requires 5 doses spaced 1 month apart. In the first RSV season of Trial 05, the incidence of MA RSV LRTI through day 150 post-dose was 0.6% (4 individuals) in the nirsevimab group and 1.0% (3 individuals) in the palivizumab group.15 In the RSV Season Two section of Trial 05, subjects receiving palivizumab during their first RSV season were re-randomized 1:1 to receive nirsevimab or palivizumab entering the second RSV season.15 Forty subjects who received palivizumab in the first RSV season received a single IM dose of nirsevimab, and 42 subjects received palivizumab. In the second RSV season trial, there were no cases of MA RSV LRTI through day 150 post- dose in all subjects.15

Interdisciplinary Approach and Collaboration

Nirsevimab may not be readily available in all clinical settings, particularly during the first season of implementation of the new recommendations.21 If nirsevimab is not available or not feasible to administer, high-risk infants should receive palivizumab in the first or second year of life, as previously recommended, or until nirsevimab becomes available. Pharmacy staff can help to maintain a supply of nirsevimab in healthcare settings, and pharmacists can help to make recommendations to prescribers in the case that nirsevimab is not available.21 Pharmacists can help to answer questions that patients may have regarding current vaccination and disease prevention schedules. Pharmacy technicians can help to keep an adequate inventory of over-the-counter products used for symptom management, disease-preventing medications, and vaccinations.21 While nirsevimab must be given in a clinic or hospital setting, other vaccinations should be well stocked, and RSV prevention options may be given in the retail pharmacy setting in older individuals as stated by the most recent CDC

guidelines.24 The most recent vaccination schedule has been published by the CDC.24

Summary

Respiratory syncytial virus typically presents with mild cold-like symptoms; however, some individuals (particularly infants), are at increased risk of developing severe illness from RSV. An estimated 58,000 to 80,000 children under the age of 5 years are hospitalized each year in the United States due to RSV infection, with approximately 100 to 300 deaths caused by RSV in this population. Premature infants, infants up to 12 months, children under 2 with CLD or CHD, children with weakened immune systems, and children with neuromuscular disorders are at higher risk of developing severe illness from RSV. Individuals who are infected usually show symptoms within 4 to 6 days after getting infected; however, they may become contagious 1 to 2 days before displaying symptoms and are usually contagious for 3 to 8 days.

Nirsevimab is indicated for the prevention of RSV in neonates and infants born during or entering their first RSV season AND children up to 24 months of age who are vulnerable to severe RSV through their second RSV season. The American Academy of Pediatrics, in agreement with the CDC, recommends nirsevimab for all infants <8 months old born during or entering their first RSV season and for children and children aged 8–19 months who are at increased risk for severe RSV disease and entering their second RSV season. Providers should refer to the package insert prior to dosing as during the first RSV season, there are weight-based dosing guidelines, and the dosing during the second season differs from dosing during the first RSV season.

Pharmacists can help to make recommendations to providers based on a child's age, weight, and other comorbidities. Pharmacy technicians play an important role in keeping these medications in stock and properly stored to help get the patients the best preventative treatment possible. All healthcare professionals should stay current on the newest developments in preventative healthcare.

Course Test

According to the CDC, most children will have an RSV infection by their

tenth birthday.

second birthday.

fourth birthday.

fifth birthday.

The risk of developing severe illness from RSV is greatest in all of the following EXCEPT

premature infants.

children younger than 2 years of age with chronic lung disease or congenital heart disease.

children over 5 years of age.

children with neuromuscular disorders.

Which of the following is true regarding transmission of RSV?

Individuals with RSV can be contagious 1 to 2 days before displaying symptoms.

RSV is contagious only when symptoms are present.

Individuals who are infected with RSV are contagious long after symptoms subside.

Individuals who are infected with RSV usually show symptoms 10 or more days after getting infected.

Which of the following everyday preventative measures can help limit the spread of RSV?

Antiviral medications are routinely used to stop the spread of RSV infection

Control strategies should only target high-risk children since healthy children rarely get RSV.

Avoid giving infected children nonprescription medications for their RSV symptoms.

Regularly wash hands for at least 20 seconds with soap and water.

Which of the following is true regarding current CDC recommendations for preventing severe RSV in children?

The CDC only recommends palivizumab for the prevention of RSV.

The CDC recommends nirsevimab-alip for all infants aged 8 months and younger born during or entering their first RSV season.

The CDC recommends nirsevimab-alip for all children aged 8–19 months who had an RSV infection the year before.

The CDC recommends nirsevimab-alip for all females of reproductive potential.

Nirsevimab-alip is not indicated for use in

immunocompromised infants.

children who were infected with RSV in their first RSV season.

females of reproductive potential.

neonates.

Which of the following is true regarding nirsevimab dosing during an infant's first RSV season?

If an individual is born during or entering the RSV season, practitioners should aim for the administration of nirsevimab within the first week of life.

If an infant is born outside of the RSV season, nirsevimab should be administered twice: once at birth and once during the RSV season.

The dose of nirsevimab during the first RSV season is always 100 mg by IM injection.

If a child undergoes cardiac surgery with cardiopulmonary bypass on their first RSV season, they should always receive an additional dose of nirsevimab 200 mg IM.

Which of the following is true regarding the storage and handling of nirsevimab?

Nirsevimab pre-filled syringes should be vigorously shaken prior to administration.

Nirsevimab must be stored frozen.

Nirsevimab should be stored at room temperature.

Nirsevimab may be kept at room temperature for a maximum of 8 hours, and any pre-filled syringe not used within 8 hours must be discarded.

Counseling points for signs and symptoms of serious allergic reaction to nirsevimab may include the following:

Muscle contractions

Pink color of skin, lips, or under fingernails

Soreness at the injection site

Swelling of the face, mouth, or tongue

Which of the following statements about nirsevimab administration is true?

Nirsevimab must be given in a clinic or hospital setting.

Nirsevimab may not be administered with other childhood vaccines.

Nirsevimab is available in a 50 mg, 100 mg, and 200 mg pre-filled syringe.

Nirsevimab should be administered in the gluteal muscle.

References

Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877

Centers for Disease Control and Prevention. RSV Surveillance & Research. CDC. July 17, 2023. https://www.cdc.gov/rsv/research/index.html#ref01. Accessed December 5, 2023.

Goldstein E, Finelli L, O'Halloran A, et al. Hospitalizations Associated with Respiratory Syncytial Virus and Influenza in Children, Including Children Diagnosed with Asthma. Epidemiology. 2019;30(6):918-926. doi:10.1097/EDE.0000000000001092

Wang L, Berger N, Davis PB, Kaelber DC, Volkow N, Xu R. Time trend and seasonality in medically attended respiratory syncytial virus (RSV) infections in US children aged 0-5 years, January 2010-January 2023. Fam Med Community Health. 2023;11(4):e002453. doi:10.1136/fmch- 2023-002453

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Symptoms and Care. CDC. September 6, 2023. https://www.cdc.gov/rsv/about/symptoms.html. Accessed November 19, 2023.

Feiler MO, Yucel R, Liu Z, et al. Trends and Non-Clinical Predictors of Respiratory Syncytial Virus (RSV) and Influenza Diagnosis in an Urban Pediatric Population. Int J Pediatr Res. 2023;9(1):112. doi:10.23937/2469-5769/1510112

Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018. JAMA Netw Open. 2022;5(2):e220527. Published 2022 Feb 1. doi:10.1001/jamanetworkopen.2022.0527

Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925. Published 2023 Aug 25.

doi:10.15585/mmwr.mm7234a4

Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis [published correction appears in Pediatr Rev. 2015 Feb;36(2):85]. Pediatr Rev. 2014;35(12):519-530. doi:10.1542/pir.35- 12-519

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). RSV in Infants and Young Children. CDC. August 4, 2023. https://www.cdc.gov/rsv/high-risk/infants-young-children.html.

Accessed November 11, 2023.

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). RSV Transmission. CDC. April 26, 2023. https://www.cdc.gov/rsv/about/transmission.html. Accessed November 19, 2023.

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). CDC. November 7, 2023.

https://www.cdc.gov/rsv/index.html. Accessed November 19, 2023.

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). RSV Prevention. CDC. November 7, 2023. https://www.cdc.gov/rsv/about/prevention.html. Accessed November 19, 2023.

Piralla A, Chen Z, Zaraket H. An update on respiratory syncytial virus. BMC Infect Dis. 2023;23(1):734. Published 2023 Oct 27. doi:10.1186/s12879-023-08730-x

Beyfortus. Prescribing information. Sanofi Pasteur, Inc. July 2023. https://products.sanofi.us/beyfortus/beyfortus.pdf. Accessed November 20, 2023.

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Respiratory Syncytial Virus (RSV) Immunizations. CDC. August 30, 2023. https://www.cdc.gov/vaccines/vpd/rsv/index.html.

Accessed December 18, 2023.

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV).CDC recommends new vaccine to help protect babies against severe respiratory syncytial virus (RSV) illness after birth. CDC. September 22, 2023. https://www.cdc.gov/media/releases/2023/p0922-RSV-maternal- vaccine.html#:~:text=On%20September%2022%2C%202023%2C%2 0members,respiratory%20tract%20infection%20in%20infants. Accessed December 18, 2023.

Fleming-Dutra KE, Jones JM, Roper LE, et al. Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(41):1115-1122. Published 2023 Oct 13.

doi:10.15585/mmwr.mm7241e1

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Update on RSV and New Vaccine Recommendation. CDC. September 22, 2023. https://www.cdc.gov/respiratory- viruses/whats-new/rsv-update-2023-09- 22.html#:~:text=In%20July%202023%2C%20CDC%20recommended, for%20them%20at%20this%20time. Accessed December 18, 2023.

Centers for Disease Control and Prevention. RSV Vaccination for Older Adults 60 Years of Age and Over. CDC. August 30, 2023.

https://www.cdc.gov/vaccines/vpd/rsv/public/older-adults.html. Accessed January 7, 2024.

American Academy of Pediatrics. ACIP and AAP recommendations for nirsevimab. AAP. August 15, 2023. https://publications.aap.org/redbook/resources/25379. (Accessed November 19, 2023).

Lee CYF, Khan SJ, Vishal F, Alam S, Murtaza SF. Respiratory Syncytial Virus Prevention: A New Era of Vaccines. Cureus. 2023;15(9):e45012. Published 2023 Sep 11. doi:10.7759/cureus.45012

Hammitt LL, Dagan R, Yuan Y, et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022;386(9):837-846. doi:10.1056/NEJMoa2110275

Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). Immunization Schedules. CDC. February 10, 2023. https://www.cdc.gov/vaccines/schedules/index.html. Accessed December 18, 2023.

DISCLAIMER

The information provided in this course is general in nature, and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

© RxCe.com LLC 2024: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.