Stelara, ustekinumab
Named-patient access overview. Stelara is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
This page is informational, not medical advice.
About Stelara
Stelara (ustekinumab) is a fully human IgG1-kappa monoclonal antibody manufactured by Janssen Biotech, the biologics arm of Johnson & Johnson. It binds the shared p40 subunit of human interleukin-12 and interleukin-23 and prevents both cytokines from engaging their cell-surface receptor IL-12RB1 on T cells, natural killer cells, and antigen-presenting cells. By blocking the IL-12 and IL-23 signaling axis upstream of Th1 and Th17 differentiation, Stelara dampens the chronic inflammatory cascade that drives several immune-mediated diseases.
Stelara carries US FDA approval across four broad disease areas: moderate-to-severe plaque psoriasis in adults and pediatric patients (six years and older), active psoriatic arthritis, moderately-to-severely active Crohn's disease, and moderately-to-severely active ulcerative colitis. The dosing schedule changes by indication: psoriasis and psoriatic arthritis use a fixed subcutaneous induction-then-maintenance schedule, while Crohn's disease and ulcerative colitis begin with a single weight-based intravenous induction infusion followed by every-eight-week subcutaneous maintenance.
The IL-12/23 mechanism gives Stelara a track record of durable response and a tolerability profile that has made it a backbone of long-term immune-mediated disease management. Because biosimilar ustekinumab products have launched in 2024 and 2025, the originator Stelara remains the brand of record for patients who have established response on the reference product and want continuity of supply through a known-provenance channel.
Stelara is supplied as a 45 mg per 0.5 mL or 90 mg per 1 mL single-dose prefilled syringe for subcutaneous use, and as a 130 mg per 26 mL single-dose vial for intravenous induction in inflammatory bowel disease. All presentations require refrigerated storage at 2 to 8 degrees Celsius, protected from light, and must not be frozen or shaken.
How Reserve Meds coordinates Stelara
- Patient or treating physician submits a named-patient request through the Patient Portal.
- Clinical team verifies appropriateness of Stelara for the patient's indication, dose, and destination country.
- Treating physician issues a prescription with clinical justification, infection screen, and TB status.
- Country-specific named-patient or personal-import documentation is prepared in the destination language.
- Stelara is sourced from a DSCSA-compliant US specialty wholesaler with full serialized traceability.
- Validated cold-chain shipment is coordinated to the patient's physician, hospital, or home infusion partner.
- A named concierge stays with the case from intake through delivery confirmation.
Access by country
Reserve Meds publishes a detailed country deep-dive for Stelara in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, infection-screening expectations, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.
Indications, in brief
Plaque psoriasis. Moderate-to-severe plaque psoriasis is a chronic immune-mediated skin disease in which T-helper-17 polarization drives keratinocyte hyperproliferation, scaling plaques, and meaningful impairment of quality of life. By blocking IL-12 and IL-23 signaling upstream of the Th17 axis, Stelara delivers durable skin clearance with an every-twelve-week maintenance interval, a cadence that suits patients who travel and want fewer injection days per year.
Psoriatic arthritis. Active psoriatic arthritis combines peripheral synovitis, enthesitis, dactylitis, axial involvement, and the skin disease of psoriasis itself. Stelara reduces joint inflammation and slows progression of structural joint damage in patients with active disease, particularly where TNF inhibition has not delivered an adequate response or is contraindicated.
Crohn's disease. In moderately-to-severely active Crohn's disease, Stelara is given as a single weight-based intravenous induction followed by every-eight-week subcutaneous maintenance. It is a first-line biologic option for patients who are intolerant of or have not responded to conventional therapy, and a meaningful option for those who have lost response to TNF inhibitors.
Ulcerative colitis. In moderately-to-severely active ulcerative colitis the IV induction plus every-eight-week subcutaneous maintenance schedule produces clinical remission and mucosal healing in a subset of patients, including those with prior biologic exposure.
What every destination country asks for
Patterns vary, but the documentation set we prepare always covers the same medical core: physician letter of medical necessity tied to the labeled indication, recent diagnostic confirmation (PASI score for psoriasis, joint count and imaging for psoriatic arthritis, endoscopy and biopsy summary for inflammatory bowel disease), prior-therapy history, infection screen including tuberculosis (interferon-gamma release assay or tuberculin skin test) and hepatitis B serology, current immunization record, the prescription itself with strength and quantity, and the country-specific named-patient or personal-import application translated into the destination language.
Cold-chain and handling
Every Stelara presentation in our supply chain travels under a validated 2 to 8 degree Celsius cold-chain with continuous temperature logging from the US wholesaler to the destination physician or pharmacy. Hand-off is documented with the temperature record, lot and serial number, and chain-of-custody signature. If any segment falls out of range, the lot is quarantined and replaced before patient administration.
Start a request for Stelara
Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, an indicative timeline, and a formal quote in your local currency and USD.
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