Generic Name and Formulations:
Ustekinumab 45mg/0.5mL, 90mg/1mL; soln for SC inj; preservative-free.

Company:
Janssen Biotech, Inc.

RECENT UPDATES
10/04/13
Newly approved indication.
Indications for STELARA:
Treatment of adults with active psoriatic arthritis; may be used alone or in combination with methotrexate.

Adult Dose for STELARA:
≥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's Dose for STELARA:
<18yrs: not eva luated.

Pharmacological Class:
Interleukin-12 and interleukin-23 antagonist.

Rems:
YES

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).

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—1; single use prefilled syringe—1
Indications for STELARA:Moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.
Adult Dose for STELARA:≥18yrs: ≤100kg: 45mg SC once then 4weeks later, then once every 12weeks. >100kg: 90mg once then 4weeks later, then once every 12weeks. Rotate inj site.
Children's Dose for STELARA:<18yrs: not eva luated.
Pharmacological Class:Interleukin-12 and interleukin-23 antagonist.
Rems:YES
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).
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—1; single use prefilled syringe—1