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This is your educational guide to understanding respiratory syncytial virus— RSV—and vaccinating with AREXVY.
Could the severity of RSV in older adults be greater than you think?
Encourage appropriate adults aged 60 years and older to get vaccinated with AREXVY.
Please see full Prescribing Information for AREXVY available on this website.
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AREXVY: Pharmacist Education Guide
Intended for US healthcare professionals only.
The Severity of RSV in Older Adults Could Be Greater Than You Think1
Encourage appropriate adults aged 60 years and older to get vaccinated with AREXVY
Not an actual patient.
RSV=respiratory syncytial virus.
Reference: 1. RSV in older adults and adults with chronic medical conditions. Centers for disease control and prevention. Accessed November 2, 2022. https://www.cdc.gov/ rsv/high-risk/older-adults.html
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Indication.
AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.
Important Safety Information.
AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of AREXVY.
Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.
The most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).
Vaccination with AREXVY may not result in protection of all vaccine recipients.
Please see full Prescribing Information for AREXVY available on this website.
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Let’s begin with an overview of RSV.
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RSV OVERVIEW
RSV=respiratory syncytial virus.
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Respiratory syncytial virus (RSV) is a common and contagious virus that is primarily spread via respiratory droplets when an infected person coughs or sneezes.
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RSV OVERVIEW
What Is RSV?
Respiratory syncytial virus (RSV) is a common and contagious virus that is primarily spread via respiratory droplets when an infected person coughs or sneezes.1-3
Not an actual patient.
References: 1. RSV in older adults and adults with chronic medical conditions. Centers for Disease Control and Prevention. Accessed November 2, 2022. https://www.cdc.gov/ rsv/high-risk/older-adults.html 2. Mesa-Frias M, Rossi C, Emond B, et al. Incidence and economic burden of respiratory syncytial virus among adults in the United States: a retrospective analysis using 2 insurance claims databases. J Manag Care Spec Pharm. 2022;28(7):753 765. doi:10.18553/jmcp.2022.21459 3. Increased interseasonal respiratory syncytial virus (RSV) activity in parts of the southern United States. Centers for Disease Control and Prevention. June 10, 2021. Accessed June 29, 2022. https://emergency.cdc.gov/ han/2021/han00443.asp
RSV=respiratory syncytial virus.
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RSV poses a real risk to older adults.
Older adults are at increased risk for severe RSV infection, including those with certain underlying conditions.
RSV infection usually presents as mild disease with cold-like symptoms but can become more severe and affect the lower respiratory tract.
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Are you aware? RSV infection usually presents as mild disease with cold-like symptoms but can become more severe and affect the lower respiratory tract.1,3
Not an actual patient.
RSV=respiratory syncytial virus.
References: 1. RSV in older adults and adults with chronic medical conditions. Centers for Disease Control and Prevention. Accessed November 2, 2022. https://www.cdc.gov/ rsv/high-risk/older-adults.html 2. Havers F. Epidemiology and burden of respiratory syncytial virus in older adults in the U.S. Presented at: Advisory Committee on Immunization Practices; June 23, 2022; Atlanta, GA. 3. Mesa-Frias M, Rossi C, Emond B, et al. Incidence and economic burden of respiratory syncytial virus among adults in the United States: a retrospective analysis using 2 insurance claims databases. J Manag Care Spec Pharm. 2022;28(7):753-765. doi:10.18553/ jmcp.2022.21459
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RSV cases usually increase during the fall and peak in the winter, but may vary by region in the United States.
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Not an actual patient.
RSV=respiratory syncytial virus.
Reference: 1. RSV surveillance & research. Centers for Disease Control and Prevention. Accessed April 17, 2023. https:// www.cdc.gov/rsv/research/index.html
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Next, we’ll discuss the efficacy of AREXVY.
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EFFICACY
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Study 1, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of this analysis, median follow-up was 6.7 months.
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EFFICACY
Study Design1
Study 1, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of this analysis, median follow-up was 6.7 months.
RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.
Reference: 1. Prescribing Information for AREXVY.
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In the study that evaluated the efficacy of AREXVY, RSV-LRTD, or respiratory syncytial virus lower respiratory tract disease, was defined based on the following criteria: the participant must have experienced at least 2 lower respiratory symptoms or signs, including at least 1 lower respiratory sign for at least 24 hours, or experienced at least 3 lower respiratory symptoms for at least 24 hours.
A severe RSV-associated LRTD was defined as an RT-PCR-confirmed RSV-associated LRTD with at least 2 lower respiratory signs or as an RT-PCR-confirmed RSV-associated LRTD episode preventing normal, everyday activities. Lower respiratory symptoms included new or increased sputum, new or increased cough, and new or increased dyspnea. Lower respiratory signs included new or increased wheezing, crackles or rhonchi, respiratory rate ≥20 respirations per minute, low or decreased oxygen saturation, and need for oxygen supplementation.
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EFFICACY
What Is RSV-LRTD?1
Respiratory syncytial virus-associated lower respiratory tract disease (RSV-LRTD) was defined based on the following criteria: the participant must have experienced at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or experienced at least 3 lower respiratory symptoms for at least 24 hours.
A severe RSV-associated LRTD was defined as an RT-PCR–confirmed RSV-associated LRTD with at least 2 lower respiratory signs or as an RT-PCR–confirmed RSV-associated LRTD episode preventing normal, everyday activities.
Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), need for oxygen supplementation.
RT-PCR=reverse transcription polymerase chain reaction.
Reference: 1. Prescribing Information for AREXVY.
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AREXVY provided exceptional efficacy for participants aged 60 years and older.
For the primary endpoint, AREXVY’s overall vaccine efficacy against RSV-LRTD was 82.6%.
At the time of this analysis, the median follow-up was 6.7 months.
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EFFICACY
Exceptional Efficacy for Patients Aged 60 Years and Older1
PRIMARY ENDPOINT
82.6% OVERALL EFFICACY AGAINST RSV-LRTD (96.95% CI, 57.9, 94.1) AREXVY (7 cases out of 12,466), placebo (40 cases out of 12,494)
SECONDARY ENDPOINT
94.6% EFFICACY AGAINST RSV-LRTD IN PARTICIPANTS WITH AT LEAST 1 COMORBIDITY* (95% CI, 65.9, 99.9) AREXVY (1 case out of 4937), placebo (18 cases out of 4861)
STUDY DESIGN1:
Study 1, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged ≥60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of this analysis, median follow-up was 6.7 months.
LRTD was defined as ≥2 lower respiratory symptoms/signs, including ≥1 lower respiratory sign for at least 24 hours, or ≥3 lower respiratory symptoms for at least 24 hours.
*Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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For the secondary endpoint, AREXVY’s vaccine efficacy against RSV-LRTD in participants aged 60 years and older with at least 1 comorbidity of interest was 94.6%.
Those comorbidities of interest were: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory or pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.
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EFFICACY
Exceptional Efficacy in Patients With Certain Comorbidities1
SECONDARY ENDPOINT
94.6% EFFICACY AGAINST RSV-LRTD IN PARTICIPANTS WITH AT LEAST 1 COMORBIDITY* (95% CI, 65.9, 99.9)
AREXVY (1 case out of 4937)
placebo (18 cases out of 4861)
PRIMARY ENDPOINT†:
82.6% overall efficacy against RSV-LRTD (96.95% CI, 57.9, 94.1)
*Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.
†Study 1, an ongoing phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). RSV-LRTD was reported in 7 participants in the AREXVY group vs 40 in the placebo group. Median follow-up for this analysis was 6.7 months.
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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Now, let’s break down the efficacy of AREXVY for other endpoints.
AREXVY’s vaccine efficacy was similar against the RSV A and RSV B subtypes for RSV-LRTD with 84.6% and 80.9%, respectively.
For severe RSV-LRTD, AREXVY was 94.1% effective. Severe RSV-associated LRTD was defined as an RT-PCR–confirmed RSV-associated LRTD with at least 2 lower respiratory signs, or as an RT-PCR–confirmed RSV-associated LRTD episode preventing normal, everyday activities.
Vaccine efficacy was 81% against RSV-LRTD in participants aged 60 to 69 years and 93.8% in participants aged 70 to 79 years.
Vaccine efficacy for participants aged 80 years and older could not be concluded due to too few cases accrued.
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EFFICACY
Efficacy by RSV Type, Severity, Age
RSV-LRTD BY SUBTYPES
84.6% Efficacy against RSV A-LRTD1 (95% CI, 32.1, 98.3)
80.9% Efficacy against RSV B-LRTD1 (95% CI, 49.4, 94.3)
SEVERE RSV-LRTD
94.1% Efficacy against severe RSV-LRTD1 (95% CI, 62.4, 99.9)
AREXVY (1 case out of 12,466), placebo (17 cases out of 12,494)
SUBGROUP ANALYSIS FOR PARTICIPANT’S AGE*
81.0% Efficacy against RSV-LRTD in participants aged 60-69 years1 (95% CI, 43.6, 95.3)
AREXVY (4 cases out of 6963), placebo (21 cases out of 6979)
93.8% Efficacy against RSV-LRTD in participants aged 70-79 years1 (95% CI, 60.2, 99.9)
AREXVY (1 case out of 4487), placebo (16 cases out of 4487)
*The vaccine efficacy in the subgroup of participants 80 years of age and older (1016 participants who received AREXVY vs 1028 participants who received placebo) cannot be concluded due to the low number of total cases accrued (2 cases among participants who received AREXVY and 3 cases among participants who received placebo).1
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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Next, let’s talk about the safety of AREXVY.
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SAFETY
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AREXVY has a demonstrated safety profile for older adults.
The tables on screen represent local adverse reactions and systemic adverse reactions for AREXVY.
The most commonly reported adverse reactions were injection site pain, fatigue, myalgia, headache, and arthralgia.
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SAFETY
A Demonstrated Safety Profile for Older Adults1
Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults aged 60 years and older (solicited safety set with 4-day diary card)
(Adverse Events Chart, showing AE, AREXVY [N=879] percentage, and placeboa [N=874] percentage)
Local Adverse Reactions
Pain, Anyb 60.9, 9.3
Pain, Grade 3b 1, 0
Erythema, >20 mm 7.5, 0.8
Erythema, >100 mm 0.2, 0
Swelling, >20 mm 5.5, 0.6
Swelling, >100 mm 0.2, 9
Systemic Adverse Reactions
Fatigue, Anyc 33.6, 16.1
Fatigue, Grade 3c 1.7, 0.5
Myalgia, Anyc 28.9, 8.2
Myalgia, Grade 3c 1.4, 0.3
Headache, Anyc 27.2, 12.6
Headache, Grade 3c 1.3, 0
Arthralgia, Anyc 18.1, 6.4
Arthralgia, Grade 3c 1.3, 0.6
Fever, ≥38.0 C/100.4 Fd 2.0, 0.3
Fever, >39.0 C/102.2 Fd 0.1, 0.1
N=exposed set for solicited safety set included all participants with at least 1 documented dose.
aPlacebo was a saline solution.
bAny grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
cAny grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
dTemperature taken by any route (oral, axillary, or tympanic).
AE=adverse event; pIMD=potential immune-mediated disease; SAE=serious adverse event.
Reference: 1. Prescribing Information for AREXVY.
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In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days, and the duration of systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.
Serious adverse events with onset within 6 months following vaccination were reported at similar rates in participants who received AREXVY (4.2%) or placebo (4.0%).
From vaccination through the first analysis, adverse events leading to death were reported for 49 participants (0.4%) who received AREXVY and 58 participants (0.5%) who received placebo.
New onset pIMDs or exacerbation of existing pIMDs within 6 months following vaccination were reported for 0.3% of participants who received AREXVY and 0.3% of participants who received placebo.
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SAFETY
A Demonstrated Safety Profile for Older Adults1
In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days and the systemic adverse reactions reported with AREXVY had a median duration ranging between 1 and 2 days.1
Similar rates of SAEs (4.2% vs 4.0%), deaths (0.4% vs 0.5%), and pIMDs (0.3% vs 0.3%) were reported between AREXVY and placebo, respectively.1
STUDY DESIGN1
Solicited AEs were evaluated in a subset of participants following a dose of AREXVY (n=879) or placebo (n=874). SAEs and pIMDs were monitored in all participants for 6 months following administration of AREXVY (n=12,467) or placebo (n=12,499), and AEs leading to deaths were monitored through the first analysis of Study 1.
AE=adverse event; pIMD=potential immune-mediated disease; SAE=serious adverse event.
Reference: 1. Prescribing Information for AREXVY.
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It’s now time to discuss how to prepare and administer AREXVY.
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DOSING AND ADMINISTRATION
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Before we start the reconstitution process, let’s begin by talking about the 2 components of AREXVY.
AREXVY is supplied in 2 vials that must be reconstituted prior to administration. One vial contains the adjuvant suspension component that is a liquid. Another vial contains the lyophilized antigen component that is a powder.
Prepare AREXVY by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). Use only the supplied adjuvant suspension component for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
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DOSING AND ADMINISTRATION
Reconstitution Instructions1
2 VIALS FOR RECONSTITUTION
AREXVY is supplied in 2 vials that must be reconstituted prior to administration.
VIAL 1
Adjuvant suspension component (liquid)
VIAL 2
Lyophilized antigen component (powder)
RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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There are several key steps to reconstituting AREXVY.
Let’s start with Step A:
Start by cleansing both vial stoppers. Then, using a sterile needle and sterile syringe, withdraw the entire contents of vial 1 containing the liquid adjuvant suspension component by slightly tilting the vial.
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DOSING AND ADMINISTRATION
Reconstitution Instructions1
STEP A: WITHDRAW
Cleanse both vial stoppers. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) by slightly tilting the vial. Vial 1 of 2.
RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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Step B:
Slowly transfer entire contents of syringe containing the liquid adjuvant into vial 2, the powder antigen component.
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DOSING AND ADMINISTRATION
Reconstitution Instructions1
STEP B: TRANSFER
Slowly transfer entire contents of syringe into the lyophilized antigen component vial (powder). Vial 2 of 2.
RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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Step C.
Gently swirl the vial until the powder is completely dissolved.
Be sure not to shake the vial vigorously.
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DOSING AND ADMINISTRATION
Reconstitution Instructions1
STEP C: SWIRL
Gently swirl the vial until the powder is completely dissolved.
DO NOT SHAKE VIGOROUSLY.
RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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And Step D.
After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.
Administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature, up to 25°C (77°F), for up to 4 hours prior to use. Discard reconstituted vaccine if not used within 4 hours or if the vaccine has been frozen.
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DOSING AND ADMINISTRATION
Reconstitution Instructions1
STEP D: AFTER RECONSTITUTION
After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.
Important to know: Administer AREXVY immediately or store protected from light in the refrigerator between 2°C and 8°C (36°F to 46°F) or at room temperature [up to 25°C (77°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours or if the vaccine has been frozen.1
RSV=respiratory syncytial virus.
Reference: 1. Prescribing Information for AREXVY.
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Information about storing AREXVY.
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STORAGE
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AREXVY should be refrigerated, never frozen. If AREXVY is ever frozen, please discard.
Store AREXVY in the original package to protect vials from light.
Store the adjuvant suspension component vials and lyophilized antigen component vials between 2°C and 8°C (or 36°F and 46°F) before reconstitution.
After reconstitution, administer immediately or store between 2°C and 8°C (or 36°F to 46°F) or at room temperature up to 25°C (77°F) for up to 4 hours prior to use.
Protect from light. Discard the reconstituted vaccine if it isn’t used within 4 hours.
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STORAGE
Storage Instructions1
AREXVY should be refrigerated. DO NOT FREEZE (discard if frozen).
Store in the original package to protect vials from light.
Store adjuvant suspension component vials and lyophilized antigen component vials between 2°C and 8°C (36°F and 46°F) before reconstitution.
After reconstitution, administer immediately or store between 2°C and 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F) for up to 4 hours prior to use.
Protect from light. Discard reconstituted vaccine if not used within 4 hours.
Reference: 1. Prescribing Information for AREXVY.
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SUMMARY
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Ensure appropriate adults aged 60 years and older are vaccinated against RSV.
Help them understand their RSV risk based on age and underlying condition.
Strongly recommend AREXVY and consider sharing individual experiences with RSV vaccination.
And talk to your patients about AREXVY when discussing seasonal influenza vaccination.
Please see full Prescribing Information for AREXVY available on this website.
That concludes your educational guide to RSV and AREXVY.
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SUMMARY
Ensure Appropriate Adults Aged 60 Years and Older Are Vaccinated Against RSV
EDUCATE | Help appropriate adults understand their RSV risk based on age and underlying condition.
RECOMMEND | Strongly recommend AREXVY for appropriate patients. Consider sharing individual experiences with RSV vaccination.
REMEMBER | Talk to your patients about AREXVY when discussing seasonal influenza vaccine.
Not an actual patient.
RSV=respiratory syncytial virus.
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