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Stelara Generic Name & Formulations
Legal Class
Rx
General Description
Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Interleukin-12 and interleukin-23 antagonist.
How Supplied
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
Manufacturer
Generic Availability
NO
Stelara Indications
Indications
Active psoriatic arthritis.
Stelara Dosage and Administration
Adult
≥18yrs: initially 45mg SC once, then 4 weeks later, followed by 45mg every 12 weeks. >100kg with co-existent moderate to severe plaque psoriasis: initially 90mg once, then 4 weeks later, followed by 90mg every 12 weeks. Rotate inj site.
Children
<6yrs: not established. Give by SC at Weeks 0 and 4, then every 12 weeks thereafter. 6–17yrs (<60kg): 0.75mg/kg; (≥60kg): 45mg; (>100kg with co-existent moderate to severe plaque psoriasis): 90mg.
Stelara Contraindications
Not Applicable
Stelara Boxed Warnings
Not Applicable
Stelara Warnings/Precautions
Warnings/Precautions
Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for posterior reversible encephalopathy syndrome (PRES); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
Stelara Pharmacokinetics
See Literature
Stelara Interactions
Interactions
Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.
Stelara Adverse Reactions
Adverse Reactions
Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, PRES, hypersensitivity reactions (discontinue if occur).
Stelara Clinical Trials
See Literature
Stelara Note
Not Applicable
Stelara Patient Counseling
See Literature
Stelara Generic Name & Formulations
Legal Class
Rx
General Description
Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Interleukin-12 and interleukin-23 antagonist.
How Supplied
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
Manufacturer
Generic Availability
NO
Stelara Indications
Indications
Moderately to severely active Crohn's disease or ulcerative colitis.
Stelara Dosage and Administration
Adult
Induction: give as a single IV infusion over 1hr. ≥18yrs (≤55kg): 260mg; (>55–85kg): 390mg; (>85kg): 520mg. Maintenance: 90mg by SC inj given 8 weeks after initial IV dose, then every 8 weeks thereafter. Rotate inj site.
Children
<18yrs: not established.
Stelara Contraindications
Not Applicable
Stelara Boxed Warnings
Not Applicable
Stelara Warnings/Precautions
Warnings/Precautions
Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for posterior reversible encephalopathy syndrome (PRES); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
Stelara Pharmacokinetics
See Literature
Stelara Interactions
Interactions
Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.
Stelara Adverse Reactions
Adverse Reactions
Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, PRES, hypersensitivity reactions (discontinue if occur).
Stelara Clinical Trials
See Literature
Stelara Note
Not Applicable
Stelara Patient Counseling
See Literature
Stelara Generic Name & Formulations
Legal Class
Rx
General Description
Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Interleukin-12 and interleukin-23 antagonist.
How Supplied
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
Manufacturer
Generic Availability
NO
Stelara Indications
Indications
Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
Stelara Dosage and Administration
Adult
≥18yrs (≤100kg): initially 45mg SC once, then 4 weeks later, and then once every 12 weeks; (>100kg): initially 90mg once, then 4 weeks later, and then once every 12 weeks. Rotate inj site.
Children
<6yrs: not established. Give by SC at Weeks 0 and 4, then every 12 weeks thereafter. 6–17yrs (<60kg): 0.75mg/kg; (60–100kg): 45mg; (>100kg): 90mg.
Stelara Contraindications
Not Applicable
Stelara Boxed Warnings
Not Applicable
Stelara Warnings/Precautions
Warnings/Precautions
Use under physician supervision. May increase risk of infections. Active infections: do not initiate. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops, monitor closely and discontinue until resolves. Risk of disseminated infections (eg, mycobacteria, salmonella, BCG vaccines) in IL-12/IL-23 genetically deficient patients. Evaluate for tuberculosis (TB) infection prior to initiating. History of latent or active TB (without confirmed adequate treatment); consider anti-TB therapy prior to initiation. Monitor for signs/symptoms of active TB during and after therapy. Patients with active TB infection: do not initiate. Consider completion of all age appropriate immunizations according to current guidelines before starting therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Monitor closely in patients aged >60yrs, history of prolonged immunosuppressant therapy, or prior PUVA treatment. Monitor for posterior reversible encephalopathy syndrome (PRES); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
Stelara Pharmacokinetics
See Literature
Stelara Interactions
Interactions
Concomitant live vaccines: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. Concomitant CYP450 substrates with narrow therapeutic index: monitor and adjust dose as needed. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis). Concomitant other immunosuppressants or phototherapy in psoriasis: not established.
Stelara Adverse Reactions
Adverse Reactions
Nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, inj site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, UTI, sinusitis, abdominal pain, influenza, fever, diarrhea, nausea; malignancies, PRES, hypersensitivity reactions (discontinue if occur).
Stelara Clinical Trials
See Literature
Stelara Note
Not Applicable
Stelara Patient Counseling
See Literature
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