Classes
DEA Class; Rx
Common Brand Names; Stelara
- Antipsoriatics, Systemic;
- Monoclonal Antibodies;
- Interleukin Inhibitors
Description
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
Indications
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
Contraindications
Hypersensitivity
Active serious infection
Concomitant live vaccines
Adverse Effects
- Upper respiratory infection
- Nasopharyngitis
- Back pain
- Cellulitis
- Depression
- Diarrhea
- Fatigue
- Headache
- Injection site erythema
- Myalgia
- Fatigue
- Nasal congestion
- Urticaria
- Rash
- Pruritus
- Antibody formation
Warnings
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
Pregnancy and Lactation
Data are not available on the presence of ustekinumab in human milk, effects on the breastfed infant, or effects on milk production
Maximum Dosage
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.
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.
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
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
