Antipsoriatic Agent; Interleukin-12 Inhibitor; Interleukin-23 Inhibitor; Monoclonal Antibody
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Stelara/Ustekinumab is a humanized monoclonal antibody that binds to proinflammatory cytokines and mediators such as interleukin-12 and -23. Stelara/Ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumour necrosis factor-alpha (TNF-α), interferon-inducible protein-10 (IP-10), and interleukin-8 (IL-8). Significant clinical improvement in psoriasis and psoriatic arthritis patients is seen in association with the reduction of these proinflammatory signalers.
Indications For Use
Officially indicated for Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Precautions
Antibody formation
Hypersensitivity reactions have been reported including anaphylaxis and angioedema
Risk of developing infections, malignancy, neurotoxicity
Do not use in patients with active or latent tuberculosis infection
Usual Dosing
Crohn Disease
Induction IV: 260mg to 520mg as a single dose; dependant on bodyweight
Maintenance SQ: Inject 90mg every 8 weeks after IV induction dose
Plaque Psoriasis
SQ: Inject 45mg to 90mg at 0, 4 weeks and then 12 weeks thereafter.
Psoriatic Arthritis
SQ: Inject 45mg at 0, 4 and then 12 weeks thereafter.
Ulcerative Colitis
Induction IV: 260mg to 520mg as a single dose; dependant on bodyweight
Maintenance SQ: Inject 90mg every 8 weeks after IV induction dose
Pharmacist Tips On Using
How to Take Ustekinumab, Stelara: Intravenous administration of Ustekinumab/Stelara should be done under the direct supervision of a medical professional. Ustekinumab/Stelara is generally administered at an infusion clinic. When administering Ustekinumab/Stelara by subcutaneous injection, inject into the top of the thigh, abdomen, upper arms, or buttocks. Rotate sites. Do not inject into tender, bruised, erythematous, or indurated skin. Avoid areas of skin where psoriasis is present. Discard any unused portion. Intended for use under the supervision of a physician; self-injection may occur after proper training.
Side Effects
The most common side effects reported in using Stelara/Ustekinumab include:
>10%:
Immunologic: Antibody development (3% to 12%; associated with reduced efficacy in psoriasis patients)
Infection: Infection (psoriasis: 27% to 72%; infection, severe: ≤3%)
Respiratory: Nasopharyngitis (11% to 24%)
Frequently Asked Questions
- What is a biosimilar drug?
A biosimilar is a biological product that is very similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency. These molecules are so large, complex, and difficult to make those slight variations in lab technique from one manufacturer to another result in minor molecular differences thereby preventing them from being considered generic. They are not completely interchangeable and therefore more supporting evidence must be provided by the manufacturer in order to be approved by the FDA/Health Canada. - Why are biosimilars more affordable than their brand counterparts?
Biosimilars are considerably more affordable than their brand name counterparts because of the lower cost in manufacturing and entering the marketplace because of minimal investment in research and development. - Is there a biosimilar for Ustekinumab?
Not currently at this point, however, many new biosimilars are being approved regularly.