Stelara

Stelara

ustekinumab

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate & PUVA. Monotherapy or in combination w/ methotrexate for the treatment of moderate to severe active psoriatic arthritis in adult patients when the response to previous nonbiological disease modifying antirheumatic drug therapy has been inadequate.
Dosage/Direction for Use
SC 45 mg administered at wk 0 & 4 then every 12 wk thereafter. Adult >100 kg 90 mg.
Contraindications
Hypersensitivity. Clinically important active infection (eg, active TB).
Special Precautions
May increase risk of infections & reactivate latent infections. Evaluate patients for TB infection prior to initiation of treatment. Latent TB should be treated prior to therapy. Patients w/ a history of latent or active TB; history of malignancy. Monitor for appearance of non-melanoma cancer. Not to be given concurrently w/ live viral/bacterial vaccines. Concomitant use w/ immunosuppressive agents or transitioning from other biologic agents. Discontinue if an anaphylactic reaction or other serious hypersensitivity reaction occurs. Pregnancy & lactation.
Adverse Reactions
Upper resp tract infection, nasopharyngitis; dizziness, headache; oropharyngeal pain; diarrhea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema, pain.
Drug Interactions
Concurrent administration w/ live vaccines.
MIMS Class
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Stelara pre-filled inj 45 mg/0.5 mL
Packing/Price
1's (Rp35,000,000/alat semprit)
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