Yuflyma (Adalimumab)

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

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  • Product Details

    Description

    Yuflyma (adalimumab-aaty) is a biosimilar to Humira (adalimumab), a fully human monoclonal antibody that binds specifically to tumor necrosis factor-alpha (TNF-a), a key mediator of inflammatory and immune responses. By blocking the interaction of TNF-a with its receptors, Yuflyma reduces inflammation and immune-mediated tissue damage. It is indicated for the treatment of multiple chronic autoimmune conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and uveitis, among others.

    Fact Table

    Formula

    C6428H9912N1694O1987S46

    License

    US FDA, EMA

    Bioavailability

    64%

    Legal status

    Rx-only

    Chemical Name

    Adalimumab

    Elimination half-life

    10–20 days

    Dosage (Strength)

    40 mg/0.4 mL or 40 mg/0.8 mL prefilled syringe or autoinjector

    Pregnancy

    Consult a doctor (Category B)

    Brands

    Yuflyma (biosimilar to Humira)

    Protein binding

    Not applicable (monoclonal antibody)

    PubChem CID

    11959600

    MedlinePlus

    a604006

    ChEBI

    75475

    ATC code

    L04AB04

    DrugBank

    DB00051

    KEGG

    D06474

    Routes of administration

    Subcutaneous injection

    Directions

    Yuflyma is administered by subcutaneous injection, with dosing regimens varying by condition and patient characteristics. For example:

    • Rheumatoid arthritis (adults): 40 mg every other week
    • Crohn’s disease (adults): 160 mg initially, 80 mg at week 2, then 40 mg every other week
    • Plaque psoriasis: 80 mg initial dose, followed by 40 mg every other week starting one week later

    Patients may self-administer Yuflyma after proper training. It is available in a prefilled autoinjector or prefilled syringe. The product should be stored refrigerated and brought to room temperature before use. Injection sites (thigh or abdomen) should be rotated with each dose.

    Ingredients

    Each 0.8 mL of Yuflyma contains:

    • Adalimumab-aaty 40 mg
    • L-histidine
    • L-histidine hydrochloride monohydrate
    • Sorbitol
    • Polysorbate 20
    • Water for injection

    Yuflyma is citrate-free, latex-free, and preservative-free, which may reduce injection site discomfort.

    Contraindications

    Yuflyma is contraindicated in patients with:

    • Known hypersensitivity to adalimumab or any component of the formulation
    • Active tuberculosis, sepsis, or other severe infections
    • Moderate to severe heart failure (in certain indications)

    Cautions

    Before starting Yuflyma, screen patients for latent or active tuberculosis and evaluate for hepatitis B. Monitor throughout therapy for infections, malignancy (especially lymphoma and skin cancers), demyelinating disorders, and cytopenias. Avoid concurrent use with other biologic immunomodulators. Live vaccines should not be given during treatment. Caution is advised in patients with a history of chronic or recurrent infections, or with underlying conditions that predispose them to infection.

    Side Effects

    Common side effects of Yuflyma include:

    • Injection site reactions (pain, redness, swelling)
    • Upper respiratory tract infections
    • Headache
    • Rash
    • Nausea
    • Sinusitis

    Serious adverse effects may include:

    • Serious infections (e.g., TB, bacterial sepsis)
    • Malignancies (lymphoma, skin cancer)
    • Hepatitis B reactivation
    • Demyelinating disease (e.g., multiple sclerosis-like syndrome)
    • Heart failure exacerbation
    • Lupus-like syndrome
    • Severe hypersensitivity reactions

    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 : 14364

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