Arthritis/rheumatic disorders:
Indications for: STELARA
Active psoriatic arthritis.
Adult Dosage:
≥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 Dosage:
<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 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 reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
STELARA Classification:
Interleukin-12 and interleukin-23 antagonist.
STELARA 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.
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, RPLS, hypersensitivity reactions (discontinue if occur).
Drug Elimination:
Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days (all psoriasis); ~19 days (Crohn disease and ulcerative colitis).
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
Colorectal disorders:
Indications for: STELARA
Moderately to severely active Crohn's disease or ulcerative colitis.
Adult Dosage:
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 Dosage:
<18yrs: not established.
STELARA 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 reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
STELARA Classification:
Interleukin-12 and interleukin-23 antagonist.
STELARA 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.
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, RPLS, hypersensitivity reactions (discontinue if occur).
Drug Elimination:
Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days (all psoriasis); ~19 days (Crohn disease and ulcerative colitis).
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
Psoriasis:
Indications for: STELARA
Moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
Adult Dosage:
≥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 Dosage:
<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 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 reversible posterior leukoencephalopathy syndrome (RPLS); discontinue and treat if suspected. Risk of noninfectious pneumonia; discontinue and treat if confirmed. Latex allergy (syringe). Pregnancy. Nursing mothers.
STELARA Classification:
Interleukin-12 and interleukin-23 antagonist.
STELARA 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.
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, RPLS, hypersensitivity reactions (discontinue if occur).
Drug Elimination:
Half-life: 14.9 ± 4.6 to 45.6 ± 80.2 days for psoriasis; ~19 days for Crohn disease and ulcerative colitis.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (45mg/0.5mL, 130mg/26mL)—1; single-dose prefilled syringe (45mg/0.5mL, 90mg/mL)—1
