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Ustekinumab

Intravenous
Subcutaneous
Class
Targeted therapy
Subclass
Anti-IL-12 and IL-23 monoclonal antibodies
Generic name
Ustekinumab
Brand names
Stelara®
Common formulations
Solution for injection
Indications for use
Labeled indications
Adults
•
Treatment of Crohn's disease (moderate-to-severe, induction of remission)
•
Treatment of ulcerative colitis (moderate-to-severe, induction of remission)
Safety risks
Contraindications
Hypersensitivity to ustekinumab or to any of its components
Warnings and precautions
Exacerbation of tuberculosis
•
Use caution in patients with a past history of latent or active tuberculosis. Consider anti-tuberculosis therapy prior to initiation of Ustekinumab in whom an adequate course of treatment cannot be confirmed.
Malignancies
•
Use caution in all patients, especially in patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment.
Mycobacterial Infection, Salmonella species infections
•
Use extreme caution in patients deficient in IL-12/IL-23.
Pneumonia
•
Maintain a high level of suspicion, as ustekinumab has been associated with increased incidences of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia.
Posterior reversible encephalopathy syndrome
•
Use caution in all patients, especially in patients with psoriasis, psoriatic arthritis and Crohn's disease.
Reactivation of infections, immunosuppression
•
Use extreme caution in patients with any clinically important active infection. Do not initiate treatment with ustekinumab until the infection resolves or is adequately treated.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if benefits outweigh potential risks. Monoclonal antibodies cross the placenta, particularly during the third trimester, and may affect the immune response of the fetus. The American Gastroenterological Association recommends continuing biologic agents for IBD throughout pregnancy and the postpartum period.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Infections, nasopharyngitis, ⊕ rapid antibody test
Common 1-10%
•
Bronchitis, carcinomatosis, fungal infections, influenza, non-melanoma skin cancer, abdominal pain, arthralgia, back pain, depression, diarrhea, dizziness, fatigue, generalized pruritus, headache, injection site reactions, nausea, throat pain, vomiting, sinusitis, tooth abnormalities, urinary tract infections, upper respiratory tract infections
Uncommon < 1%
•
Acute diverticulitis, anaphylaxis, cellulitis, herpes zoster ophthalmicus, injection site pain
Unknown frequency
•
Acute interstitial pneumonia, allergic reactions, angioedema, cryptogenic organizing pneumonia, cutaneous squamous cell carcinoma, cutaneous pseudolymphoma, eczema, heart failure, posterior reversible encephalopathy syndrome, psoriasis, pulmonary eosinophilia, thrombotic thrombocytopenic purpura
Interactions
Drug(s)
Check Interactions
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