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Ustekinumab

    Brands

    DEA Class; Rx

    Common Brand Names; Stelara

    • Antipsoriatics, Systemic; 
    • Monoclonal Antibodies; 
    • Interleukin Inhibitors

    Interleukin (IL)-12 and IL-23 antagonist; given intravenously and subcutaneously
    Used for moderate to severe plaque psoriasis and active psoriatic arthritis (PsA) in adult and pediatric patients 6 years and older, and for adults with moderate to severely active Crohn’s disease or ulcerative colitis
    As with other interleukin inhibitors, may increase risk of infection

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

    Indicated for adults with active psoriatic arthritis alone or in combination with methotrexate

    Hypersensitivity

    Active serious infection

    Concomitant live vaccines

    • Upper respiratory infection
    • Nasopharyngitis
    • Back pain
    • Cellulitis
    • Depression
    • Diarrhea
    • Fatigue
    • Headache
    • Injection site erythema
    • Myalgia
    • Fatigue
    • Nasal congestion
    • Urticaria
    • Rash
    • Pruritus
    • Antibody formation

    Use caution in patients genetically deficient in IL-12/IL-23

    Reversible posterior leukoencephalopathy syndrome (RPLS) reported (1 case); cases reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease; if RPLS is suspected, administer appropriate therapy and discontinue treatment

    Provide age-appropriate immunization prior to initiating therapy

    Hypersensitivity reactions reported, including anaphylaxis and angioedema

    Data are not available on the presence of ustekinumab in human milk, effects on the breastfed infant, or effects on milk production

    Adults

    Psoriasis and Psoriatic Arthritis
    Weighing more than 100 kg: 90 mg/dose subcutaneously for plaque psoriasis +/- psoriatic arthritis and 45 mg/dose subcutaneously for psoriatic arthritis alone; maintenance therapy every 12 weeks.
    Weighing 100 kg or less: 45 mg/dose subcutaneously; maintenance therapy every 12 weeks.
     
    Crohn’s Disease and Ulcerative Colitis
    Weighing more than 85 kg: 520 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.
    Weighing 56 to 85 kg: 390 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.
    Weighing 55 kg or less: 260 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.

    Geriatric

    Psoriasis and Psoriatic Arthritis
    Weighing more than 100 kg: 90 mg/dose subcutaneously for plaque psoriasis +/- psoriatic arthritis and 45 mg/dose subcutaneously for psoriatic arthritis alone; maintenance therapy every 12 weeks.
    Weighing 100 kg or less: 45 mg/dose subcutaneously; maintenance therapy every 12 weeks.
     
    Crohn’s Disease and Ulcerative Colitis
    Weighing more than 85 kg: 520 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.
    Weighing 56 to 85 kg: 390 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.
    Weighing 55 kg or less: 260 mg single dose IV and 90 mg/dose subcutaneously every 8 weeks.

    Adolescents

    Psoriasis and Psoriatic Arthritis
    Weighing more than 100 kg: 90 mg/dose subcutaneously for plaque psoriasis +/- psoriatic arthritis and 45 mg/dose subcutaneously for psoriatic arthritis alone; maintenance therapy every 12 weeks.
    Weighing 60 to 100 kg: 45 mg/dose subcutaneously; maintenance therapy every 12 weeks.
    Weighing less than 60 kg: 0.75 mg/kg/dose subcutaneously; maintenance therapy every 12 weeks.

    Children

    Psoriasis and Psoriatic Arthritis
    6 to 12 years weighing more than 100 kg: 90 mg/dose subcutaneously for plaque psoriasis +/- psoriatic arthritis and 45 mg/dose subcutaneously for psoriatic arthritis alone; maintenance therapy every 12 weeks.
    6 to 12 years weighing 60 to 100 kg: 45 mg/dose subcutaneously; maintenance therapy every 12 weeks.
    6 to 12 years weighing less than 60 kg: 0.75 mg/kg/dose subcutaneously; maintenance therapy every 12 weeks.
    1 to 5 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Ustekinumab 

    injectable solution for SC

    • 45mg/0.5mL (prefilled syringe or single-dose vial)

    • 90mg/mL (prefilled syringe)

    injectable solution for IV infusion

    • 130mg/26mL (5mg/mL) single-dose vial