GSK-3536819 (MenABCWY)

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    Description

    GSK-3536819 (MenABCWY) is a multicomponent meningococcal conjugate vaccine developed by GSK for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. The MenABCWY vaccine combines the antigenic components of Bexsero (MenB) and Menveo (MenACWY), offering broad protection in a single formulation. Designed for individuals aged 10 to 25 years, particularly those at increased risk of exposure, MenABCWY GSK represents a significant advancement in meningococcal disease prevention. Healthcare providers and institutions seeking to buy MenABCWY can now access a streamlined immunization option that simplifies scheduling and improves adherence to meningococcal vaccination recommendations.

    Fact Table
    Formula Not applicable (vaccine – biologic formulation)
    License FDA approved (October 2023)
    Bioavailability Not applicable (intramuscular injection)
    Legal status Prescription only (Rx)
    Chemical Name Meningococcal Group A, C, W, Y and B Vaccine
    Elimination half-life Not applicable
    Dosage (Strength) Single-dose injection (0.5 mL)
    Pregnancy Consult healthcare provider
    Brands Penbraya
    Protein binding Not applicable
    PubChem CID Not listed
    MedlinePlus Not assigned
    ChEBI Not available
    ATC code J07AH10
    DrugBank Not assigned
    KEGG Not available
    Routes of administration Intramuscular injection

    Directions

    The MenABCWY vaccine is administered intramuscularly as a two-dose series. The recommended dosing schedule is an initial dose followed by a second dose administered six months later. For optimal immunogenic response, the vaccine should be administered into the deltoid muscle. The dosing schedule must be adhered to, and it is essential to complete the full series to ensure protective efficacy against all five serogroups.

    Ingredients

    Each dose of MenABCWY contains purified capsular polysaccharide antigens from Neisseria meningitidis serogroups A, C, W, and Y conjugated to CRM197, along with recombinant proteins from serogroup B (fHbp, NadA, and NHBA). The vaccine also includes aluminum hydroxide as an adjuvant, histidine, sodium chloride, and water for injection. The formulation does not contain preservatives or latex.

    Cautions

    Caution is advised when administering the MenABCWY vaccine to individuals with a history of Guillain-Barré Syndrome. As with any vaccine, immunization may not result in protection in all vaccine recipients. Administration should be deferred in individuals suffering from acute febrile illness. The vaccine should be used with caution in patients with bleeding disorders or those receiving anticoagulant therapy, as intramuscular injections may cause hematoma. Providers considering offering or advertising the option to buy MenABCWY should ensure appropriate patient assessment and counseling are conducted.

    Contraindications

    GSK-3536819 (MenABCWY) is contraindicated in individuals with a known hypersensitivity to any component of the vaccine, including diphtheria toxoid or CRM197. It should not be administered to individuals who have experienced a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a meningococcal vaccine.

    Side Effects

    Common side effects associated with the MenABCWY vaccine may include:

    • Pain, redness, or swelling at the injection site
    • Fatigue or malaise
    • Headache
    • Fever
    • Nausea or gastrointestinal discomfort
    • Myalgia or arthralgia

    These side effects are generally mild to moderate and resolve within a few days. Serious adverse reactions are rare but should be promptly reported and managed according to clinical guidelines.

    Frequently Asked Questions about GSK-3536819 (MenABCWY)


    What is GSK-3536819 (MenABCWY)?

    GSK-3536819 is a pentavalent meningococcal vaccine that provides protection against five meningococcal serogroups: A, B, C, W, and Y. It combines the coverage of existing MenACWY and MenB vaccines into a single product.


    Who should receive the MenABCWY vaccine?

    The vaccine is designed for adolescents and young adults who are at increased risk of meningococcal disease, particularly those entering college, military recruits, or individuals with certain medical conditions that increase their susceptibility.


    How is the MenABCWY vaccine administered?

    It is administered as an intramuscular injection, typically in the deltoid muscle of the upper arm. The vaccination schedule usually consists of two doses given at least one month apart.


    What are the common side effects of the MenABCWY vaccine?

    Common side effects include pain, redness, or swelling at the injection site, fatigue, headache, muscle or joint pain, fever, and nausea. Most side effects are mild to moderate and resolve within a few days.


    Does the MenABCWY vaccine replace the need for separate MenACWY and MenB vaccines?

    Yes, the MenABCWY vaccine is designed to provide protection against all five major disease-causing meningococcal serogroups in a single vaccine, potentially eliminating the need for separate vaccinations.


    How long does protection from the MenABCWY vaccine last?

    Current data suggests protection lasts for several years, though long-term studies are ongoing. Some individuals may require booster doses based on their risk factors or exposure.


    Can the MenABCWY vaccine be given at the same time as other vaccines?

    Yes, the MenABCWY vaccine can generally be administered concurrently with other vaccines, though they should be given at different injection sites. Always consult with a healthcare provider for specific recommendations.


    Is the MenABCWY vaccine covered by insurance?

    Coverage varies by insurance provider. Once fully approved, many insurance plans may cover the vaccine, especially for recommended age groups or those with risk factors. Check with your insurance provider for specific coverage details.


    Are there any contraindications for receiving the MenABCWY vaccine?

    The vaccine should not be given to individuals with a history of severe allergic reaction to any component of the vaccine. Those who are moderately or severely ill should wait until recovery before receiving the vaccine.


    How does the MenABCWY vaccine differ from previous meningococcal vaccines?

    The key advantage is comprehensive coverage against serogroups A, B, C, W, and Y in a single vaccine. Previous vaccines only covered either serogroup B or serogroups A, C, W, and Y, requiring multiple vaccinations for complete protection.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 15330

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