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Wezlana (Ustekinumab)

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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

    Wezlana (ustekinumab-aekn) is a biosimilar to Stelara (ustekinumab), a human monoclonal antibody that targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23). It is indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years and older), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis in adults. By inhibiting IL-12 and IL-23 mediated inflammatory pathways, Wezlana helps control systemic and skin inflammation associated with immune-mediated diseases. As a biosimilar, Wezlana has demonstrated no clinically meaningful differences in efficacy, safety, or immunogenicity compared to its reference product.

    Fact Table

    Formula

    C6452H9952N1712O2004S46

    License

    US FDA (2023)

    Bioavailability

    ~57% (subcutaneous)

    Legal status

    Rx-only

    Chemical Name

    Ustekinumab-aaty

    Elimination half-life

    ~15–45 days (mean ~21 days)

    Dosage (Strength)

    45 mg/0.5 mL and 90 mg/mL prefilled syringes; 130 mg/26 mL IV vial

    Pregnancy

    Use only if clearly needed; crosses placenta in 2nd/3rd trimesters

    Brands

    Wezlana (biosimilar to Stelara)

    Protein binding

    Not applicable (monoclonal antibody)

    PubChem CID

    Not available (biologic)

    MedlinePlus

    a609042

    ChEBI

    Not assigned

    ATC code

    L04AC05

    DrugBank

    DB06190

    KEGG

    D08876

    Routes of administration

    Subcutaneous, Intravenous

    Directions

    Wezlana is administered by subcutaneous injection for psoriasis and psoriatic arthritis, and with an initial intravenous induction followed by subcutaneous maintenance for Crohn’s disease and ulcerative colitis.

    Plaque Psoriasis (Adults and Children =6 years): Weight-based subcutaneous dosing at weeks 0 and 4, then every 12 weeks.

    Psoriatic Arthritis (Adults): 45 mg SC at weeks 0 and 4, then every 12 weeks; may be used alone or with methotrexate.

    Crohn’s Disease / Ulcerative Colitis (Adults): Initial single IV induction dose (~6 mg/kg), followed by 90 mg SC every 8 weeks starting at week 8.

    Administration should be supervised by a healthcare professional. Injection sites should be rotated, and patients should be instructed on proper self-injection technique if appropriate.

    Ingredients

    Active Ingredient: Ustekinumab-aekn (biosimilar to ustekinumab)

    Inactive Ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection. Formulated as a sterile, preservative-free solution for injection.

    Contraindications

    Wezlana is contraindicated in patients with:

    Hypersensitivity to ustekinumab or any component of the formulation

    Clinically significant active infections

    Cautions

    Before starting Wezlana, evaluate patients for tuberculosis (TB); latent TB should be treated prior to initiating therapy. Use with caution in patients with a history of recurrent infections or conditions predisposing to infections. Live vaccines should not be administered during treatment. Patients should be monitored for signs of infection, malignancy, and hypersensitivity reactions, including anaphylaxis. There is a theoretical risk of increased malignancy due to immune modulation.

    Side Effects

    Common side effects include:

    Upper respiratory tract infections

    Headache

    Fatigue

    Injection site reactions

    Diarrhea

    Serious side effects may include:

    Serious infections (e.g., TB, opportunistic infections)

    Malignancies

    Hypersensitivity reactions, including anaphylaxis

    Reversible posterior leukoencephalopathy syndrome (RPLS)

    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 : 15168

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