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Ixekizumab

    DEA Class; Rx

    Common Brand Names; Taltz

    • Interleukin Inhibitors

    Subcutaneous humanized IgG4 monoclonal antibody that selectively targets interleukin-17A (IL-17A)
    Used to treat moderate to severe plaque psoriasis in patients 6 years and older, used in adults for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis
    As with other interleukin inhibitors, may increase risk of infection

    Indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

    Indicated for moderate-to-severe plaque psoriasis

    Indicated for active psoriatic arthritis

    Indicated for active ankylosing spondylitis

    Indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation

    Hypersensitivity reaction (eg, anaphylaxis) to drug or excipients

    • Injection site reactions (17%)
    • Upper respiratory tract infections (14%)
    • Thrombocytopenia, Grade 1 (3%)
    • Nausea (2%)
    • Tinea infections (2%)
    • Serious hypersensitivity reactions
    • Serious infections
    • Neutropenia
    • Rhinitis
    • Oral candidiasis
    • Urticaria
    • Influenza
    • Conjunctivitis
    • Inflammatory bowel disease
    • Angioedema

    Serious hypersensitivity reactions reported, including angioedema and urticaria; anaphylaxis reported, some requiring hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy

    Patients receiving treatment may be at increased risk of inflammatory bowel disease; in clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in treated group than placebo control group; during treatment, monitor for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue therapy and initiate appropriate medical management

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy

    There are no available data on presence of this drug in human milk, effects on breastfed infant, or on milk production

    Adults

    160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy for psoriasis, psoriatic arthritis, and ankylosing spondyloarthritis; for non-radiographic axial spondyloarthritis 80 mg/dose subcutaneously.

    Geriatric

    160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy for psoriasis, psoriatic arthritis, and ankylosing spondyloarthritis; for non-radiographic axial spondyloarthritis 80 mg/dose subcutaneously.

    Adolescents

    more than 50 kg: 160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
    25 to 50 kg: 80 mg/dose subcutaneously initially, then 40 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
    less than 25 kg: 40 mg/dose subcutaneously initially, then 20 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

    Children

    6 years or older and more than 50 kg: 160 mg/dose subcutaneously initially, then 80 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
    6 years or older and 25 to 50 kg: 80 mg/dose subcutaneously initially, then 40 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
    6 years or older and less than 25 kg: 40 mg/dose subcutaneously initially, then 20 mg/dose subcutaneously for maintenance therapy of plaque psoriasis; safety and efficacy have not been established for psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
    1 to 5 years: Safety and efficacy have not been established.

    Infants

    Not indicated.

    Neonates

    Not indicated.

    Ixekizumab 

    prefilled autoinjector, single-dose

    • 80mg/mL

    prefilled syringe, single-dose

    • 80mg/mL