Search

Stelara

Stelara

ustekinumab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma

Marketer:

Johnson & Johnson
Concise Prescribing Info
Contents
Ustekinumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who have failed to respond to, or who have CI to or are intolerant to other systemic therapies (SC only). Active psoriatic arthritis in adult patients when response to previous non-biological DMARD therapy has been inadequate (SC only). 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 (IV for induction dosing & SC for maintenance dosing). Moderately to severely active ulcerative colitis who have had inadequate response w/ lost response to, or were intolerant to either conventional therapy or biologic or have medical CI to such therapies (IV for induction dosing & SC for maintenance dosing).
Click to view Stelara detailed prescribing information
Dosage/Direction for Use
Plaque psoriasis Initially 45 mg SC, followed by 45 mg dose 4 wk later, then every 12 wk thereafter. Psoriatic arthritis Initially 45 mg SC, followed by 45 mg dose 4 wk later, then every 12 wk thereafter, or 90 mg for body wt >100 kg. Crohn's disease & ulcerative colitis 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.
Click to view Stelara detailed prescribing information
Contraindications
Severe hypersensitivity to ustekinumab or any excipients.
Click to view Stelara detailed prescribing information
Special Precautions
Infections, do not give to patients w/ clinically important, active infection, evaluate patient for TB infection prior to initiating treatment. Malignancies, caution in 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. Immunizations, do not give live viral or live bacterial vaccines concurrently. Serious skin conditions, erythrodermic psoriasis or exfoliative dermatitis symptoms reported, discontinue if drug reaction is suspected. Latex sensitivity. Pregnancy & lactation. Childn <18 yr.
Click to view Stelara detailed prescribing information
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.
Click to view Stelara detailed prescribing information
Drug Interactions
Not to be given concurrently w/ live vaccines.
Click to view Stelara detailed prescribing information
Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Stelara detailed prescribing information
Storage
View Stelara storage conditions for details to ensure optimal shelf-life.
Description
View Stelara description for details of the chemical structure and excipients (inactive components).
Action
View Stelara mechanism of action for pharmacodynamics and pharmacokinetics details.
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
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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in