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Zymfentra (Infliximab)

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  • Product Details

    Description

    Zymfentra (infliximab-dyyb) is a subcutaneous formulation of infliximab, a biosimilar to Remicade, and the first FDA-approved subcutaneous infliximab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Infliximab is a chimeric monoclonal antibody that binds specifically to tumor necrosis factor-alpha (TNF-a), a pro-inflammatory cytokine that plays a central role in the pathogenesis of autoimmune diseases. Zymfentra provides an alternative route of administration for patients previously stabilized on intravenous infliximab, offering the convenience of self-injection and sustained disease control.

    Fact Table

    Formula

    C6428H9912N1694O1987S46

    License

    US FDA (2023)

    Bioavailability

    ~79% (SC, Zymfentra)

    Legal status

    Rx-only

    Chemical Name

    Infliximab-dyyb

    Elimination half-life

    7–12 days

    Dosage (Strength)

    120 mg/0.8 mL (SC), once every 2 weeks (after IV induction)

    Pregnancy

    Consult a doctor (Category B)

    Brands

    Zymfentra (SC); Inflectra, Remicade (IV)

    Protein binding

    Not applicable (monoclonal antibody)

    PubChem CID

    16130156

    MedlinePlus

    a604023

    ChEBI

    75468

    ATC code

    L04AB02

    DrugBank

    DB00065

    KEGG

    D02597

    Routes of administration

    Subcutaneous (Zymfentra), Intravenous (original infliximab)

    Directions

    Zymfentra is intended for maintenance treatment only and should be initiated after completion of an induction regimen with intravenous infliximab. The recommended dosage is:

    • 120 mg subcutaneously every 2 weeks for both ulcerative colitis and Crohn’s disease in adults.

    The injection should be administered into the thigh or abdomen, alternating sites with each dose. Zymfentra is supplied as a prefilled single-dose autoinjector or syringe. Patients or caregivers may administer the injection after proper training.

    Ingredients

    Each 1 mL dose of Zymfentra contains:

    • Infliximab-dyyb 120 mg
    • Histidine
    • Trehalose dihydrate
    • Polysorbate 80
    • Water for injection

    The product is preservative-free, citrate-free, and latex-free, contributing to reduced injection site discomfort.

    Contraindications

    Zymfentra is contraindicated in patients with:

    • Known hypersensitivity to infliximab, murine proteins, or any excipients
    • Moderate to severe heart failure (NYHA class III/IV)
    • Active infections, including tuberculosis or sepsis

    Cautions

    Zymfentra, like all TNF inhibitors, carries a risk of serious infections including tuberculosis, invasive fungal infections, and opportunistic pathogens. Screen all patients for latent TB before starting therapy. Regular monitoring for signs of infection, malignancy, demyelinating disease, and autoimmune reactions is recommended. Hepatitis B reactivation may occur; screen patients prior to initiation. Avoid use in combination with other biologics. Live vaccines should not be administered during treatment.

    Side Effects

    Common side effects of Zymfentra include:

    • Injection site reactions (redness, pain, itching)
    • Upper respiratory tract infections
    • Headache
    • Nausea
    • Abdominal pain
    • Fatigue

    Serious adverse effects may include:

    • Serious infections (e.g., TB, fungal, sepsis)
    • Malignancies (e.g., lymphoma, skin cancers)
    • Demyelinating disease
    • Hepatitis B reactivation
    • 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 : 15184

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