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Stelara

Stelara

ustekinumab

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. Monotherapy or in combination w/ MTX in adults w/ active psoriatic arthritis (PsA). Moderate to severe active Crohn's disease in adults who have failed or were intolerant to immunomodulators, corticosteroids or ≥1 anti-TNF treatment, or were corticosteroid-dependent. Moderately to severely active ulcerative colitis in adults.
Dosage/Direction for Use
Plaque psoriasis & PsA 45 mg SC administered at wk 0 & 4, then every 12 wk thereafter. Alternatively, 90 mg may be used in patient >100 kg. Crohn's disease & ulcerative colitis Patient >85 kg 520 mg as single IV dose, followed by 90 mg SC 8 wk later, then every 8 wk thereafter, >55 to ≤85 kg 390 mg as single IV dose, followed by 90 mg SC 8 wk later, then every 8 wk thereafter, ≤55 kg 260 mg as single IV dose, followed by 90 mg SC 8 wk later, then every 8 wk thereafter.
Contraindications
Special Precautions
Discontinue use if an anaphylactic or other serious hypersensitivity reaction occurs. Not to be given to patients w/ clinically important, active infection or active TB. May potentially increase risk of infections & malignancy, & reactivate latent infections. Patients w/ chronic infection or history of recurrent infection; history of malignancy or those who develop malignancy. Contains dry natural rubber which may cause allergic reactions in latex-sensitive individuals. Evaluate patients for TB infection prior to initiating treatment. Closely monitor for signs & symptoms of active TB during & after treatment; if patient develops serious infection & do not administer treatment until infection resolves. Monitor for appearance of non-melanoma skin cancer in patient particularly those >60 yr, w/ medical history of prolonged immunosuppressant therapy or w/ history of PUVA treatment. Not to be given concurrently w/ live viral or bacterial vaccines. Combination w/ immunosuppressive agents or phototherapy, or when transitioning from other biologic agents; allergy immunotherapy particularly for anaphylaxis. No studies conducted in patients w/ renal or hepatic impairment; childn <12 yr; ped patients w/ Crohn's disease or ulcerative colitis. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
URTI, nasopharyngitis, sinusitis; dizziness, headache; oropharyngeal pain; diarrhea, nausea, vomiting; pruritus; back pain, myalgia, arthralgia; fatigue, inj site erythema & pain.
Drug Interactions
Not to be concurrently given w/ live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Stelara conc soln for IV infusion 130 mg/26 mL
Packing/Price
26 mL x 1's
Form
Stelara soln for SC inj 45 mg/0.5 mL
Packing/Price
(pre-filled syringe) 0.5 mL x 1's (P114,239/box)
Form
Stelara soln SC for inj 90 mg/mL
Packing/Price
(pre-filled syringe) 1 mL x 1's
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