Supemtek (Quadrivalent Recombinant Influenze Vaccine)

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  • Product Details

    Description

    Supemtek® is a quadrivalent recombinant influenza vaccine developed by Sanofi Pasteur. It is designed to provide active immunization against influenza caused by two influenza A virus subtypes (H1N1 and H3N2) and two influenza B virus lineages (Victoria and Yamagata). Unlike traditional egg-based vaccines, Supemtek® is produced using recombinant DNA technology in an insect cell line, allowing for an exact genetic match to the World Health Organization (WHO) recommended strains . This method eliminates the risk of egg-adapted mutations, potentially enhancing vaccine effectiveness.

    Fact Table

    Formula

    Recombinant HA proteins from 4 influenza strains

    License

    EMA (EU), 2020

    Bioavailability

    High (intramuscular absorption)

    Legal status

    Rx-only

    Chemical Name

    Quadrivalent recombinant influenza vaccine (QIVr)

    Elimination half-life

    Not applicable (vaccine antigen)

    Dosage (Strength)

    0.5 mL containing 45 µg of HA per strain (180 µg total)

    Pregnancy

    Use if clearly needed; consult physician

    Brands

    Supemtek

    Protein binding

    Not applicable

    PubChem CID

    Not assigned

    MedlinePlus

    a621048

    ChEBI

    Not listed

    ATC code

    J07BX03

    DrugBank

    DB11621

    KEGG

    D10962

    Routes of administration

    Intramuscular injection

    Directions

    Supemtek® is administered as a single 0.5 mL intramuscular injection, preferably into the deltoid muscle of the upper arm. It is indicated for adults 18 years of age and older. Annual vaccination is recommended, as influenza virus strains and immunity levels can change each year .

    Ingredients

    Each 0.5 mL dose of Supemtek® contains:

    • 45 micrograms of recombinant hemagglutinin (HA) protein per strain, totaling 180 micrograms for all four strains
    • Polysorbate 20 (E432)
    • Sodium chloride
    • Sodium phosphate monobasic monohydrate
    • Sodium phosphate dibasic dodecahydrate
    • Water for injections

    Supemtek® is egg-free, latex-free, and contains no preservatives or antibiotics .

    Contraindications

    Supemtek® is contraindicated in individuals with:

    • Hypersensitivity to the active substances or any of the excipients listed above
    • Known allergy to octylphenol ethoxylate, a trace residual from the manufacturing process

    Cautions

    • Postpone vaccination in individuals with acute febrile illness until recovery
    • Immunocompromised individuals may have a diminished immune response
    • As with all vaccines, appropriate medical treatment should be available in case of an anaphylactic reaction
    • Supemtek® may not provide protection against all circulating influenza strains or in all vaccinated individuals

    Side Effects

    Very common (may affect more than 1 in 10 people):

    • Injection site pain and tenderness
    • Fatigue
    • Headache
    • Muscle and joint pain (in adults 18–49 years of age)

    Common (may affect up to 1 in 10 people):

    • Nausea
    • Redness, swelling, or hardness at the injection site
    • Fever (>38°C) (in adults 18–49 years of age)
    • Shivering
    • Muscle and joint pain (in adults 50 years of age and older)

    Uncommon (may affect up to 1 in 100 people):

    • Dizziness
    • Gastrointestinal symptoms (e.g., diarrhea, vomiting)
    • Lymphadenopathy (swollen lymph nodes)

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    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 : 14596

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