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Adtralza (Tralokinumab)

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  • Product Details

    Description

    Adtralza, known by its generic name Tralokinumab, is a monoclonal antibody prescribed to treat adults with moderate to severe atopic dermatitis, commonly known as eczema. It targets interleukin-13 (IL-13), a key protein involved in inflammation and symptoms associated with atopic dermatitis. Adtralza may help reduce the immune system's overactivity that causes inflammation. Doctors and healthcare providers may prescribe this medication for patients not receiving adequate relief from topical treatments. It may sometimes be used in combination with topical corticosteroids to better manage the condition.

    Fact Table

    Formula

    C6404H9886N1702O2008S44

    License

    US FDA (2021), EMA (2021)

    Bioavailability

    76% (subcutaneous)

    Legal status

    Prescription only (Rx)

    Chemical Name

    Tralokinumab

    Elimination half-life

    ~22 days

    Dosage (Strength)

    150 mg/1 mL solution; initial: 600 mg (four 150 mg injections), then 300 mg every 2 weeks

    Pregnancy

    Use only if clearly needed; insufficient human data

    Brands

    Adtralza (EU), Adbry (US)

    Protein binding

    Not applicable (monoclonal antibody)

    PubChem CID

    25081261

    MedlinePlus

    a622035

    ChEBI

    Not available

    ATC code

    D11AH07

    DrugBank

    DB11703

    KEGG

    D11995

    Routes of administration

    Subcutaneous

    Directions

    Adtralza is administered as a subcutaneous injection, which is an injection just under the skin. The initial dose is typically 600 mg, with subsequent 300 mg doses administered every other week. Follow your healthcare provider’s instructions and make sure the skin is clean and free from any signs of infection before injecting. It’s recommended to rotate injection sites to reduce irritation.

    Ingredients

    Adtralza injections contain the active ingredient Tralokinumab.

    Contraindications

    Avoid taking or using this medication if you have a known hypersensitivity to Tralokinumab or experienced an allergic reaction to any ingredient of the Adtralza formulation.

    Cautions

    • Before starting on Adtralza, discuss the following with a doctor or healthcare provider:
      • Allergies to medication ingredients, to avoid severe reactions.
      • Current medications, including over-the-counter drugs and supplements, as they can interact with Adtralza.
      • Medical history, especially infections or immune system problems, since Adtralza may affect immune responses.
      • Pregnancy status or intentions, as effects on the unborn child are not well established.
      • Breastfeeding plans, because it's unknown if Adtralza passes into breast milk.
    • Make sure the name and batch number of Adtralza are recorded when you receive it. This is important for tracking the use of this biological medicine.
    • If you have a hypersensitivity reaction after taking Adtralza, like a rash, swelling, or difficulty breathing, stop using the medication and seek medical help immediately.
    • In case you develop inflammation of the eye that doesn't respond to usual treatments while on Adtralza, an eye exam may be recommended.
    • Before starting Adtralza, treat any existing helminth infections. If you get a helminth infection during treatment and standard treatments don't work, you might need to pause your Adtralza therapy until the infection is resolved.
    • You should avoid live vaccines while using Adtralza, as their safety with this medication hasn't been established. It's recommended to bring your vaccinations up to date with the current guidelines before starting Adtralza.
    • Adtralza contains very little sodium, less than 1 mmol (23 mg) per 150 mg dose, which is almost sodium-free. This may be important if you're monitoring your sodium intake.

    Side Effects

    Adtralza may cause a range of side effects, though not everyone will experience them. The most common side effects include eye discomfort and symptoms of the common cold, such as body aches, chills, coughing, and ear congestion. Some people also report headaches and a stuffy or runny nose.

    Certain adverse reactions to Adtralza may be more severe and require immediate attention. These could involve signs of allergic reactions like hives and swelling of the face, lips, or tongue which could potentially affect breathing. If any of these severe side effects occur, contact a healthcare provider promptly.

    References:

    1. Adtralza (Tralokinumab) Summary of Product Characteristics. Ballerup, Denmark: LEO Pharma; 2021.
    2. Adtralza (Tralokinumab) Medicine Overview. Amsterdam, The Netherlands: European Medicines Agency; 2022.



    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 : 14428

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