Stelara

Stelara

ustekinumab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Soln for inj in pre-filled syringe only (SC) Treatment of moderate to severe plaque psoriasis in adults who failed to respond, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, or PUVA (psoralen & UVA). Treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Soln for inj in pre-filled syringe (SC) & conc for soln for infusion (IV) Treatment of adult patients w/ moderately to severely active Crohn's disease who have had an inadequate response w/, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Dosage/Direction for Use
Plaque psoriasis & psoriatic arthritis Soln for inj in pre-filled syringe Adult 45 mg SC at wk 0 & 4 then every 12 wk thereafter. Patient w/ body wt >100 kg 90 mg SC at wk 0 & 4 then every 12 wk thereafter. Crohn's disease Conc for soln for infusion Initial IV dosing based on body wt, administered over at least 1 hr. Patient w/ body wt >85 kg 520 mg, >55 kg to ≤85 kg 390 mg, ≤55 kg 260 mg. Soln for inj in pre-filled syringe 1st SC dose of 90 mg should take place at wk 8 after the IV dose, then every 12 wk.
Contraindications
Hypersensitivity. Clinically important, active infection (eg, active TB).
Special Precautions
Potential to increase risk of infections & reactivate latent infections. Evaluate patient for TB prior to treatment. History & increased risk of malignancy. Discontinue if anaphylactic or other serious hypersensitivity reaction occurs. Do not give live bacterial or viral vaccines concurrently. Concomitant immunosuppressive therapy. Allergy immunotherapy. Discontinue if erythrodermic psoriasis or exfoliative dermatitis occurs. Latex sensitivity (pre-filled syringe only). Renal & hepatic impairment. Women of childbearing potential should use effective methods of contraception. Pregnancy & lactation. Childn <18 yr w/ Crohn's disease. Elderly.
Adverse Reactions
Upper resp tract infection, nasopharyngitis; dizziness, headache; oropharyngeal pain; diarrhoea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema or pain.
Drug Interactions
Do not give concurrently w/ live vaccines.
MIMS Class
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Stelara inj 90 mg/mL
Packing/Price
1's
Form
Stelara inj 45 mg/0.5 mL
Packing/Price
1's
Form
Stelara conc for soln for infusion 130 mg
Packing/Price
1's
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