Stelara (Ustekinumab) Infusion Therapy in New York

For Crohn's disease and ulcerative colitis, Stelara begins with one intravenous infusion and then becomes an injection. For plaque psoriasis and psoriatic arthritis it is an injection from the start. In the FDA-approved labeling, the intravenous route is used for exactly two indications, and only for the first dose: a single weight-based induction infusion given over a period of at least one hour. Eight weeks later, maintenance moves to a 90 mg subcutaneous injection, repeated every eight weeks.

This is the part most pages get wrong, and it changes what you should expect. If you have been referred to an infusion center for Stelara for Crohn's disease or ulcerative colitis, you are coming in for one appointment, not a course of infusions. After that visit the medication is normally given as a subcutaneous injection every eight weeks, and an infusion center has no further role in your ustekinumab therapy unless your prescriber decides that you cannot self-administer.

The two presentations are not interchangeable with one another. The 130 mg/26 mL (5 mg/mL) single-dose vial is the intravenous form and is never given subcutaneously; the 45 mg/0.5 mL and 90 mg/mL prefilled syringes and the 45 mg vial are subcutaneous and are never given intravenously.

Stelara (ustekinumab) carries four FDA-approved indications, and the approved age range differs among them. The wording below is the label's own, from the Highlights of the current prescribing information.

Two boundaries are worth stating precisely, because they are often reported incorrectly. Ulcerative colitis is an adult-only indication. Section 8.4 of the label states that "the safety and effectiveness of STELARA have not been established in pediatric patients with ulcerative colitis," so use in a child with ulcerative colitis is off-label — FDA has not approved that use, and the decision belongs to the treating physician. Crohn's disease is approved from 2 years of age, with the labeled pediatric dosing starting at a 10 kg body-weight floor; the label states that safety and effectiveness have not been established below 2 years. That pediatric expansion appears in the label's Recent Major Changes as a 4/2026 change to Indications and Usage and to the dosing sections.

The induction dose is set by body weight and is given once. For adults with either Crohn's disease or ulcerative colitis, the label specifies three bands.

For pediatric Crohn's disease (2 years and older, from 10 kg), the label gives 10 mg/kg for 10 kg to 25 kg, then 260 mg above 25 kg up to 55 kg, 390 mg above 55 kg up to 85 kg, and 520 mg above 85 kg — the same three adult bands once a child passes 25 kg.

What the appointment involves

All of this comes from the label's preparation and administration instructions. The intravenous vial "must be diluted" and "prepared and infused by a healthcare professional using aseptic technique." The diluent is 0.9% Sodium Chloride Injection, with 0.45% Sodium Chloride also permitted for adults. The final volume is 250 mL for adults and for pediatric patients over 25 kg, and 100 mL for pediatric patients 10 kg to 25 kg. The infusion set must carry "an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer)." The label directs: "Infuse the diluted solution over a period of at least one hour" and "Do not infuse STELARA concomitantly in the same intravenous line with other agents."

Your visit runs longer than the infusion itself, because it also includes check-in, a weight in kilograms (the dose depends on it), vital signs, intravenous access, preparation of the diluted bag, and monitoring while the drug runs. The label notes that "some serious hypersensitivity reactions have occurred during the first intravenous dose of STELARA" — that is the reason this particular visit is attended rather than routine.

After induction. Adults with Crohn's disease or ulcerative colitis receive 90 mg subcutaneously 8 weeks after the intravenous dose, then every 8 weeks. For pediatric Crohn's disease the first subcutaneous dose is also 8 weeks after induction and then every 8 weeks: 2.5 mg/kg for 10 kg to 35 kg, and 90 mg above 35 kg.

Stelara's FDA-approved labeling carries no boxed warning. That is a statement about the label and nothing more: it does not mean the medication is without serious risks, and it is not a comparison with any other product. Stelara is an immunosuppressant, and its Warnings and Precautions section runs to eight subsections — these are what the pre-treatment workup exists to address.

• Infections (5.1). Stelara "may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed." Reported serious infections include diverticulitis, cellulitis, pneumonia, appendicitis, sepsis and osteomyelitis. The label directs avoiding initiation "in patients with any clinically important active infection until the infection resolves or is adequately treated." Updated 4/2026.
• Pre-treatment evaluation for tuberculosis (5.3). "Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA." Avoid giving Stelara to patients with active tuberculosis; treat latent tuberculosis first. The label requires the evaluation but does not name a particular test or interval.
• Theoretical risk for vulnerability to particular infections (5.2). People genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated mycobacterial, salmonella and BCG infections.
• Malignancies (5.4). Stelara "may increase the risk of malignancy," and its safety "has not been evaluated in patients who have a history of malignancy or who have a known malignancy." The label directs monitoring all patients for non-melanoma skin cancer.
• Serious hypersensitivity reactions (5.5). "Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported." Some have occurred during the first intravenous dose. Updated 11/2025.
• Posterior reversible encephalopathy syndrome (5.6). Two cases of PRES, also known as reversible posterior leukoencephalopathy syndrome, were reported in clinical trials, with headaches, seizures, confusion and visual disturbances.
• Immunizations (5.7). Patients "should receive all age-appropriate immunizations" before starting, and "should avoid receiving live vaccines" during treatment.
• Noninfectious pneumonia (5.8). Interstitial, eosinophilic and cryptogenic organizing pneumonia have been reported after approval.

Stelara is contraindicated "in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in STELARA." On pregnancy, the label reports that available registry, literature and pharmacovigilance data "have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes"; on lactation, that limited published data suggest ustekinumab is present in human breast milk. Both belong in a conversation with your prescriber.

FDA has licensed eight biosimilars referencing Stelara, approved between October 2023 and May 2025: Wezlana (ustekinumab-auub), Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Yesintek (ustekinumab-kfce), Steqeyma (ustekinumab-stba) and Starjemza (ustekinumab-hmny). FDA defines a biosimilar as "a biologic that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biological medication, called a reference product."

An interchangeable biosimilar has met additional requirements and "may be substituted for the reference product at the pharmacy level, depending on state pharmacy laws"; to earn that designation a manufacturer must show "that switching between the two products would not increase safety risks or decrease effectiveness." Interchangeability is a dispensing designation, not a quality ranking — every FDA-licensed biosimilar met the same "no clinically meaningful differences" standard, and one without the designation is not a lesser or less-tested product.

Four ustekinumab biosimilars can be confirmed as interchangeable from FDA or manufacturer primary sources: Wezlana (October 31, 2023), Selarsdi and Pyzchiva (both April 30, 2025), and Otulfi (May 19, 2025). We do not state an interchangeability status for the other four, because we could not confirm one from an FDA source — and a payer document describing a product as interchangeable is not an FDA determination. The authoritative place to check any product is the FDA Purple Book.

One practical point patients often have backwards: pharmacy-level substitution happens at a pharmacy counter. A drug infused at an infusion center under the medical benefit is selected by the prescriber and the plan's medical policy instead. So if you are told your ustekinumab product is changing, the reason is usually a change to your plan's product list, not anything about your disease. The weight bands, the one-hour minimum infusion and the 8-week interval are the same, because biosimilars are approved to the same labeled dosing. Choosing between them is a prescriber decision, and we do not recommend one ustekinumab product over another.

Prime Infusions operates 13 infusion centers across New York, plus one in Atlanta: Astoria, Jamaica, Howard Beach and Fresh Meadows in Queens; Brooklyn (Foster Ave) and Boro Park; the Upper East Side; Staten Island; Great Neck in Nassau County and Inwood in the Five Towns; Port Jefferson Station in Suffolk County; and New City in Rockland County and Monroe in Orange County. Which center can schedule your induction dose is confirmed by our care team when the referral arrives; per-center product availability is not published. Reach us at 718-443-4000, Monday to Friday, 9:00AM to 5:00PM, or through contact us.

Site of care. UnitedHealthcare's site-of-care policy (Provider Administered Drugs – Site of Care, 2026D0121V, effective August 1, 2026) names ustekinumab explicitly, under HCPCS J3357 (subcutaneous) and J3358 (intravenous). It treats a physician office, an ambulatory or freestanding infusion suite and home infusion as the standard places of service, and considers hospital outpatient administration medically necessary only on documented criteria, reassessed at six months.

Prior authorization, and a fact worth hearing here rather than from your plan. Under UnitedHealthcare's commercial medical benefit drug policy for ustekinumab (2026D0045AA, effective June 1, 2026), the products it lists as preferred are Starjemza, Steqeyma, Wezlana and Yesintek. Brand Stelara is listed as non-preferred, along with Imuldosa, Otulfi, Pyzchiva and Selarsdi. Approving a non-preferred product there requires documentation of a trial of at least 14 weeks of a preferred product "resulting in minimal clinical response to therapy and residual disease activity," or documented intolerance, contraindication or adverse event to one. For Crohn's disease the policy also requires that treatment be "prescribed by or in consultation with a gastroenterologist," that "ustekinumab is to be administered as a single intravenous induction dose," and it states plainly: "Authorization will be for one induction dose." Subcutaneous maintenance is a separate request 8 weeks later, capped at 12 months.

Other plans draw the line differently — Anthem's Medical Drug Clinical Criteria CC-0063, last reviewed August 15, 2025, lists a different set of preferred agents, including Stelara IV. That is the point: product lists differ by payer and change often, so no clinic can tell you in advance which ustekinumab product your plan will cover. Prime Infusions verifies benefits and submits the authorization request with your prescriber; coverage, prior authorization and out-of-pocket cost are determined solely by your health plan, and we cannot guarantee approval. Physicians can start a referral from our Treatment Referrals directory.

Because Medicare treats the two doses as two different kinds of drug. Part B pays for drugs furnished incident to a physician's service that are "not usually self-administered by the patient." Under the CMS process for making that determination, "the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug," and each Medicare Administrative Contractor publishes a Self-Administered Drug (SAD) Exclusion List naming the HCPCS codes excluded from Part B on that basis.

Ustekinumab lands on both sides of that line. On the SAD exclusion list applicable to New York (Article A53021, revision effective August 29, 2026), J3357 — ustekinumab for subcutaneous injection — is excluded, an exclusion effective October 15, 2021. J3358, ustekinumab for intravenous injection, is not on that list. The same split appears on other contractors' lists.

The practical consequence for a Medicare patient with Crohn's disease or ulcerative colitis: the single induction infusion at the center is billed under the medical benefit, and every subcutaneous maintenance dose after it runs through the Part D prescription drug benefit. That means two deductibles, two cost-sharing structures, two appeal pathways and often two different phone numbers, for one medication. It is worth arranging the Part D side before the induction visit rather than discovering it eight weeks later.

The difference is not trivial. HHS Office of Inspector General report OEI-BL-19-00500 (August 6, 2024) found that "Medicare and some enrollees paid substantially more when Stelara injections were covered under Part D (i.e., self-administered) versus under Part B," with 2021 annual per-enrollee costs 80 percent higher under Part D.

One caution about how to read all of this: a SAD exclusion list determines what is excluded from Part B, not whether any particular claim will be paid. Coverage still depends on your own plan and on a medical necessity determination, and we cannot tell you what you will owe.

The treatment goals in the conditions Stelara is approved to treat include clearer skin, reduced joint pain, and better management of gastrointestinal symptoms. Whether an individual patient reaches them varies, and is assessed by the prescribing clinician. Its less frequent dosing schedule—compared to other biologics—makes it a convenient long-term solution for managing chronic inflammatory conditions.