Stelara 130 mg Injection

Molecule: Ustekinumab

Strength: 130 mg

Quantity: Single dose vial

Form: Injection

Packaging Type: Vial

Manufacturer/Marketed By: Janssen Pharmaceuticals

Country of Origin: Belgium

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Overview

- Introduction
- Benefits
- Indications and Usage
- How it Works
- Dosage & Administration
- Side Effects
- Warning and Precaution
- Clinical Trial & Approvals

Description

Stelara (ustekinumab) is a fully human monoclonal antibody that targets the p40 subunit shared by interleukins IL-12 and IL-23, key drivers of inflammation. Available as a 130 mg single-dose IV infusion (loading dose) and 45/90 mg subcutaneous injection, Stelara is used to treat several immune-mediated inflammatory conditions.

Benefits

Rapid and durable skin clearance: Many psoriasis patients achieve significant improvement by week 12 
Effective long-term maintenance: Over 50% of ulcerative colitis patients maintained remission through 4 years 
Convenient dosing: After initial loading, subcutaneous injections every 8–12 weeks, reducing treatment burden compared to more frequent biologics

Indications and Usage

Stelara is FDA-approved for:

Moderate to severe plaque psoriasis in adults and children (≥ 6 yrs)
Active psoriatic arthritis in adults and children (≥ 6 yrs)
Moderate to severe Crohn’s disease and ulcerative colitis in adults

How it Works

Ustekinumab binds to the p40 subunit of IL-12 and IL-23, thereby preventing these cytokines from activating immune responses. By blocking IL‑12/IL‑23 pathway activation of Th1/Th17 cells, it reduces inflammation and halts tissue damage in psoriasis and IBD. 

Dosage & Administration

For Crohn’s disease / ulcerative colitis:

Initial IV infusion 130 mg (or weight-based 260–520 mg)
Followed by SC injection of 90 mg every 8 weeks

For psoriasis / psoriatic arthritis:

45 mg SC at Week 0, Week 4, then every 12 weeks
90 mg dose recommended for adults weighing > 100 kg for enhanced response

Injection sites include the upper arm, thigh, abdomen, or buttocks. IV infusions take at least 1 hour 

Side Effects

Common (≥ 4%)

Upper respiratory infections (“common cold”), headache, injection-site reactions
Itchy skin, nausea, vomiting, bronchitis, sinus infections, urinary tract infections, vaginal yeast infections

Serious (less common)

Increased risk of infections; monitor for signs of TB and serious bacterial/fungal infections
Hypersensitivity reactions, possible malignancy risk from immunosuppression

Warning and Precaution

Infection risk: Screen for tuberculosis before initiating therapy
Hypersensitivity: Monitor during and after the first dose
Malignancy: Long-term immunosuppression may slightly increase the risk
Live vaccines: Avoid during treatment
Follow medical guidance when switching to biosimilars (e.g., Selarsdi/Otulfi)

Clinical Trial & Approvals

FDA first approved in 2009 for plaque psoriasis, expanded for psoriatic arthritis (2013), Crohn’s disease (2016), and ulcerative colitis (2019) 
Long-term UC data: over half of patients maintained remission at 4 years 
Multiple biosimilars (e.g., Selarsdi, Otulfi, Pyzchiva) are now FDA-approved interchangeable versions

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