Zuellig Pharma


Johnson & Johnson
Concise Prescribing Info
Moderately to severely active Crohn's disease in adult patients who had inadequate response w/, lost response to or were intolerant to either conventional therapy or tumor necrosis factor-α (TNFα) antagonist or have medical contraindications to such therapies. Moderate to severe plaque psoriasis in adults who failed to respond to, contraindicated, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (Psoralen & UVA). Alone or in combination w/ MTX for active psoriatic arthritis when the response to previous non-biological disease-modifying anti-rheumatic drugs (DMARDs) therapy is inadequate.
Dosage/Direction for Use
Crohn's disease Induction: Patient >85 kg 520 mg single IV infusion over at least 1 hr, >55 kg-≤85 kg 390 mg single IV infusion over at least 1 hr, ≤55 kg 260 mg single IV infusion over at least 1 hr. Maintenance: Initially 90 mg SC at wk 8 after IV dose, followed by dosing every 12 wk. Plaque psoriasis or psoriatic arthritis Initially 45 mg SC followed by 45-mg dose 4 wk later & then every 12 wk thereafter. Patient >100 kg Initially 90 mg SC followed by 90-mg dose 4 wk later & then every 12 wk thereafter.
Severe hypersensitivity to ustekinumab or any excipients.
Special Precautions
Discontinue use if serious hypersensitivity reactions including anaphylaxis & angioedema; erythrodermic psoriasis or exfoliative dermatitis symptoms occur. Not to be given in patients w/ active infection & TB. Increased risk of infections & reactivate latent infections; malignancy. Chronic or history of recurrent infection. Evaluate patient for TB infection prior to therapy. Initiate latent TB infection treatment prior to therapy. Monitor for appearance of non-melanoma skin cancer in patients >60 yr, w/ medical history of prolonged immunosuppressant therapy or PUVA treatment. Not to be given concurrently w/ live viral or bacterial vaccines. Concomitant use of immunosuppressives. Latex sensitivity. Transitioning from other biologic agents. Patients receiving or have received allergy immunotherapy particularly for anaphylaxis. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Upper resp tract infection, nasopharyngitis, sinusitis; dizziness, headache; oropharyngeal pain; diarrhea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema & pain.
Drug Interactions
Not to be given concurrently w/ live vaccines.
MIMS Class
Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Stelara infusion conc 130 mg/26 mL
((single-use)) 1's
Stelara soln for inj 45 mg/0.5 mL
Stelara soln for inj 90 mg/mL
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