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STELARA
Arthritis/rheumatic disorders
Colorectal disorders
Psoriasis
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Drug Name:

STELARA Rx

Generic Name and Formulations:
Ustekinumab 45mg/0.5mL, 90mg/mL; soln for SC inj; or 130mg/26mL; soln for IV infusion; preservative-free.

Company:
Janssen Biotech, Inc.

Therapeutic Use:

Indications for STELARA:

Treatment of adults with active psoriatic arthritis; may be used alone or in combination with methotrexate.

Adult:

≥18yrs: 45mg SC once then 4 weeks later, followed by 45mg every 12 weeks. Co-existent moderate-to-severe plaque psoriasis weighing >100kg: 90mg once then 4 weeks later, followed by 90mg every 12 weeks. Rotate inj site.

Children:

<18yrs: not established.

Warnings/Precautions:

Active infections: do not initiate therapy. Chronic or history of recurrent infection. Conditions that predispose to infection. Increased risk of serious or fatal infections, esp. in IL-12/IL-23 genetically deficient patients (eg, mycobacteria, salmonella, BCG vaccines). Monitor for new infection; discontinue if serious infection develops. Test for and treat latent tuberculosis prior to initiating therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs or is suspected. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Concomitant live vaccines, other immunosuppressants, phototherapy: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. May affect CYP450 substrates. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis).

Pharmacological Class:

Interleukin-12 and interleukin-23 antagonist.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infection, headache, fatigue; infections, malignancies, RPLS, hypersensitivity reactions (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Single-use vial (45mg/0.5mL, 130mg/26mL)—1; single-use prefilled syringe (45mg/0.5mL, 90mg/mL)—1

Indications for STELARA:

In moderately-to-severely active Crohn's disease: in adult patients who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or, failed or were intolerant to treatment with ≥1 TNF blockers.

Adult:

Induction: give as a single IV infusion over 1hr. ≥18yrs (≤55kg): 260mg; (>55–85kg): 390mg; (>85kg): 520mg. Maintenance: 90mg by SC given 8 weeks after initial IV dose, then every 8 weeks thereafter. Rotate inj site.

Children:

<18yrs: not established.

Warnings/Precautions:

Active infections: do not initiate therapy. Chronic or history of recurrent infection. Conditions that predispose to infection. Increased risk of serious or fatal infections, esp. in IL-12/IL-23 genetically deficient patients (eg, mycobacteria, salmonella, BCG vaccines). Monitor for new infection; discontinue if serious infection develops. Test for and treat latent tuberculosis prior to initiating therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs or is suspected. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Concomitant live vaccines, other immunosuppressants, phototherapy: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. May affect CYP450 substrates. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis).

Pharmacological Class:

Interleukin-12 and interleukin-23 antagonist.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infection, headache, fatigue; infections, malignancies, RPLS, hypersensitivity reactions (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Single-use vial (45mg/0.5mL, 130mg/26mL)—1; single-use prefilled syringe (45mg/0.5mL, 90mg/mL)—1

Indications for STELARA:

Moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.

Adult:

≥18yrs: ≤100kg: 45mg SC once then 4 weeks later, then once every 12 weeks. >100kg: 90mg once then 4 weeks later, then once every 12 weeks. Rotate inj site.

Children:

<18yrs: not established.

Warnings/Precautions:

Active infections: do not initiate therapy. Chronic or history of recurrent infection. Conditions that predispose to infection. Increased risk of serious or fatal infections, esp. in IL-12/IL-23 genetically deficient patients (eg, mycobacteria, salmonella, BCG vaccines). Monitor for new infection; discontinue if serious infection develops. Test for and treat latent tuberculosis prior to initiating therapy. Avoid close contact with live vaccine recipients. History of malignancies. Monitor for appearance of non-melanoma skin cancer. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs or is suspected. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Concomitant live vaccines, other immunosuppressants, phototherapy: not recommended. Do not give BCG vaccines during or within 1 year of starting or stopping ustekinumab. Non-live vaccines: may get suboptimal response. May affect CYP450 substrates. Caution with concomitant allergen immunotherapy (esp. for anaphylaxis).

Pharmacological Class:

Interleukin-12 and interleukin-23 antagonist.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infection, headache, fatigue; infections, malignancies, RPLS, hypersensitivity reactions (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Single-use vial (45mg/0.5mL, 130mg/26mL)—1; single-use prefilled syringe (45mg/0.5mL, 90mg/mL)—1

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