Stelara

Stelara

ustekinumab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma

Marketer:

Johnson & Johnson
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Plaque psoriasis & psoriatic arthritis (SC only), pediatric plaque psoriasis (SC by single-use vial only), Crohn's disease & ulcerative colitis (IV for induction dosing, SC for maintenance dosing).
Dosage/Direction for Use
Plaque psoriasis 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 therafter. Ped ≥6 yr, <60 kg 0.75 mg/kg SC at wk 0 & 4, then every 12 wk therafter, ≥60 to ≤100 kg 45 mg SC at wk 0 & 4, then every 12 wk therafter, >100 kg 90 mg SC (single-use vial only) at wk 0 & 4, then every 12 wk therafter. 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 therafter. Crohn's disease & ulcerative colitis Induction: Patient >85 kg 520 mg IV, >55 to ≤85 kg 390 mg IV, ≤55 kg 260 mg IV. Maintenance: Initially 90 mg SC at wk 8 after IV dose, followed by dosing every 12 wk.
Contraindications
Severe hypersensitivity to ustekinumab or any excipients.
Special Precautions
Infections, do not give to patients w/ clinically important active infection, evaluate patient for TB infection prior to initiating treatment. Malignancies, patients w/ history of malignancy or when considering continuing treatment in patients who develop malignancy, monitor for appearance of non-melanoma skin cancer in patients w/ medical history of prolonged immunosuppressant therapy or those w/ history of PUVA treatment. Hypersensitivity reactions, discontinue use if serious hypersensitivity reactions including anaphylaxis & angioedema occur. Immunizations, do not give live viral or live bacterial vaccines concurrently. Immunosuppression, concomitant use of immunosuppressive agents. Immunotherapy, patients receiving or who have received allergy immunotherapy particularly for anaphylaxis. Serious skin conditions, erythrodermic psoriasis or exfoliative dermatitis symptoms reported, discontinue if drug reaction is suspected. Latex sensitivity. Pregnancy & lactation. Childn <18 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 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.
Presentation/Packing
Form
Stelara infusion conc (vial) 130 mg/26 mL
Packing/Price
(single-use) 1's
Form
Stelara soln for inj (pre-filled syringe) 45 mg/0.5 mL
Packing/Price
1's
Form
Stelara soln for inj (pre-filled syringe) 90 mg/mL
Packing/Price
1's
Form
Stelara soln for inj (vial) 45 mg/0.5 mL
Packing/Price
(single-use) 1's
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