Product Information
Registration Status: ActiveSTELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45mg/0.5ML is approved to be sold in Singapore with effective from 2011-05-08. It is marketed by JOHNSON & JOHNSON PTE LTD, with the registration number of SIN13995P.
This product contains Ustekinumab 45mg/0.5mL in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Cilag AG in UNITED STATES, andBaxter Pharmaceutical Solutions LLC in SWITZERLAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Ustekinumab, is a human immunosuppressive drug developed by the biotechnology company Centocor. It is a laboratory-manufactured, monoclonal antibody directed against interleukins IL-12 and IL-23. Since 2009, ustekinumab has been approved in US, Canada, and Europe for the treatment of plaque psoriasis and psoriatic arthritis. In September 2016, Janssen announced that the FDA approved the medication for the treatment of moderate-severe Crohn's disease.
Indication
Ustekinumab is indicated for management of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; or is used alone or in conjunction with methotrexate for the management of active psoriatic arthritis in adults. The FDA approved the use of ustekinumab in September 2016 for the treatment of moderate to severe Crohn's disease. The use of ustekinumab may improve short term clinical response but not clinical remission in moderate to severe Crohn's disease.
Mechanism of Action
Ustekinumab is a human IgG1-kappa monoclonal antibody designed to interfere with the triggering of the body's inflammatory response through the suppression of certain cytokines. Specifically, ustekinumab blocks interleukin IL-12 and IL-23 by binding with high affinity and specificity to the p40 subunit of IL-12 and IL-23, therefore disrupting the proinflammatory pathway that contributes to several chronic diseases. In a more minor role, ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-α), interferon-inducible protein-10 (IP-10), and interleukin IL-8.
Pharmacokinetics
- Absorption
- Following a subcutaneous administration of a single 45 or 90mg dose (in patients with psoriasis), peak serum concentrations are achieved in a median of 13.5 or 7 days, respectively.
- Distribution
- Plaque psoriasis and psoriatic arthritis dosing: 45mg: ~0.161L/kg 90mg: ~0.179L/kg
- Metabolism
- Expected to be degraded into small peptides and amino acids.
- Elimination
Active Ingredient/Synonyms
Stelera | Ustekinumab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.