A Demonstrated Safety Profile1

For patients aged 60 years and older

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in
individuals aged 60 years and older (solicited safety set with 4-day diary card)

 
AREXVY %
Placeboa %
Local Adverse Reactions
N=879
N=874
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 0
Systemic Adverse Reactions
N=879
N=878
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 and who completed their diary.

  • a

    Placebo was a saline solution.

  • b

    Any 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).

  • c

    Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

  • d

    Temperature taken by any route (oral, axillary, or tympanic).

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%) and pIMDs (0.3% vs 0.3%) were reported between AREXVY (N=12,467) and placebo (N=12,499), respectively.1
Deaths were reported in 0.9% and 0.9% of participants who received AREXVY (N=12,469) and placebo (N=12,503), respectively.

    For patients aged 50-59 years

    Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination from Study 4 (exposed set)
     
    AREXVY 50-59 YOA %
    Placeboa 50-59 YOA %
    Local Adverse Reactions
    N=756
    N=379
    Pain, Anyb 75.8 12.1
    Pain, Grade 3b
    		 3.4 0.3
    Erythema, >20 mm
    		 13.2 0.5
    Erythema, >100 mm
    		 0.5 0
    Swelling, >20 mm 10.4 0.8
    Swelling, >100 mm 0.1 0
    Systemic Adverse Reactions
    N=756
    N=380
    Fatigue, Anyc 39.8 18.2
    Fatigue, Grade 3c 2.8 0.8
    Myalgia, Anyc 35.6 9.7
    Myalgia, Grade 3c 2.5 0.5
    Headache, Anyc 31.7 16.8
    Headache, Grade 3c  2.6 1.1
    Arthralgia, Anyc 23.4 7.9
    Arthralgia, Grade 3c 1.7 0.8
    Fever, ≥38.0 °C/ 100.4 °Fd 3.2 1.1
    Fever, >39.0 °C/ 102.2 °Fd 0.1 0.5
     
    AREXVY
    50-59 YOA %
    Placeboa
    50-59 YOA %
    Local Adverse Reactions
    N=756
    N=379
    Pain, Anyb 75.8 12.1
    Pain, Grade 3b
    		 3.4 0.3
    Erythema, >20 mm
    		 13.2 0.5
    Erythema, >100 mm
    		 0.5 0
    Swelling, >20 mm 10.4 0.8
    Swelling, >100 mm 0.1 0
    Systemic Adverse Reactions
    N=756
    N=380
    Fatigue, Anyc 39.8 18.2
    Fatigue, Grade 3c 2.8 0.8
    Myalgia, Anyc 35.6 9.7
    Myalgia, Grade 3c 2.5 0.5
    Headache, Anyc 31.7 16.8
    Headache, Grade 3c  2.6 1.1
    Arthralgia, Anyc 23.4 7.9
    Arthralgia, Grade 3c 1.7 0.8
    Fever, ≥38.0 °C/ 100.4 °Fd 3.2 1.1
    Fever, >39.0 °C/ 102.2 °Fd 0.1 0.5

    N=exposed set included all participants with at least 1 documented dose and with completed diary card.

    • a

      Placebo was a saline solution.

    • b

      Any 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).

    • c

      Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

    • d

      Temperature taken by any route (oral or axillary).

    The median duration of solicited local and systemic adverse reactions after AREXVY vaccination was 2-3 days and 1-2 days, respectively.1
    The rates of solicited local and systemic adverse reactions were similar in participants 50-59 years of age with or without medical conditions associated with an increased risk of RSV-LRTD.1
    Among participants 50-59 years of age, serious adverse events (2.3% vs 2.1%), deaths (0.5% vs 0.3%), and potential immune-mediated diseases (0.5% vs 0.3%) were reported after receiving AREXVY (N=769) or placebo (N=383), respectively.1

      For patients aged 18-49 years

      Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination from Study 7 (exposed set)
       
      AREXVY 18-49 YOA %
      Local Adverse Reactions
      N=1026
      Pain, Anya 76.0
      Pain, Grade 3a
      		 1.3
      Erythema, >20 mm
      		 8.6
      Erythema, >100 mm
      		 0.2
      Swelling, >20 mm 7.0
      Swelling, >100 mm 0.2
      Systemic Adverse Reactions
      N=1027
      Fatigue, Anyb 59.6
      Fatigue, Grade 3b 3.0
      Myalgia, Anyb 59.9
      Myalgia, Grade 3b 2.1
      Headache, Anyb 43.6
      Headache, Grade 3b  2.1
      Arthralgia, Anyb 28.3
      Arthralgia, Grade 3b 1.2
      Fever, ≥38.0 °C/ 100.4 °Fc 5.0
      Fever, >39.0 °C/ 102.2 °Fc 1.1
       
      AREXVY
      18-49 YOA %
      Local Adverse Reactions
      N=1026
      Pain, Anya 76.0
      Pain, Grade 3a
      		 1.3
      Erythema, >20 mm
      		 8.6
      Erythema, >100 mm
      		 0.2
      Swelling, >20 mm 7.0
      Swelling, >100 mm 0.2
      Systemic Adverse Reactions
      N=1027
      Fatigue, Anyb 59.6
      Fatigue, Grade 3b 3.0
      Myalgia, Anyb 59.9
      Myalgia, Grade 3b 2.1
      Headache, Anyb 43.6
      Headache, Grade 3b  2.1
      Arthralgia, Anyb 28.3
      Arthralgia, Grade 3b 1.2
      Fever, ≥38.0 °C/
      100.4 °Fc      		 5.0
      Fever, >39.0 °C/
      102.2 °Fc      		 1.1

      N = Exposed set included all participants with at least 1 documented dose and with available data.

      • a

        Any 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).

      • b

        Any grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).

      • c

        Temperature taken by any route (oral or axillary).

      The median duration of solicited local and systemic adverse reactions after AREXVY vaccination was 2-3 days and 1-2 days, respectively.1
      Within 6 months postvaccination, among participants 18 through 49 years of age who received AREXVY (N=1029), no SAEs related to vaccination were reported, while 0.2% of participants reported new onset pIMDs or exacerbation of existing pIMDs.

        Indication & Important Safety Info

        Indication

        Important Safety Information

        Indication

        AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

        • individuals 60 years of age and older;
        • individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

         

        Limitations of Use

        AREXVY is not for use in pregnant individuals.

        Important Safety Information

        • AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
        • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
        • Appropriate medical treatment must be immediately available to manage potential 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
        • In adults 60 years of age and older, 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%)
        • In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)
        • In adults 18 through 49 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%)
        • Vaccination with AREXVY may not result in protection of all vaccine recipients

         

        Please see full Prescribing Information.

        To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
        1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

        pIMD=potential immune-mediated disease; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease; SAE=serious adverse event.

        Reference

        1. Prescribing Information for AREXVY.

        Questions About AREXVY?

        Call: 1-877-AREXVY1 (1-877-273-9891) Available Monday - Friday 8:30 am - 5:30 pm ET