Infliximab (Remicade) Infusion Therapy in New York

Infliximab is a tumor necrosis factor (TNF) blocker given by intravenous infusion. The FDA-approved prescribing information for REMICADE (revised 2/2025) lists eight indications, and the population attached to each one is part of the indication. Two details are easy to get wrong and worth stating up front: rheumatoid arthritis is a combination indication — the label indicates REMICADE for RA in combination with methotrexate, not on its own — and the only pediatric indications are Crohn's disease and ulcerative colitis, in patients 6 years of age and older.

Off-label use, stated plainly. Ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis are adult-only indications; there is no pediatric approval for any of them. Any other use — hidradenitis suppurativa, uveitis, sarcoidosis, Behcet's disease, pyoderma gangrenosum, graft-versus-host disease — is off-label, meaning FDA has not approved infliximab for it. Medicare contractor billing guidance does contemplate infliximab claims for pyoderma gangrenosum with coexisting inflammatory bowel disease under specific paired ICD-10 rules, but that is a coverage pathway, not an FDA indication. Ask the prescribing physician which indication your order is written under.

Infliximab is always intravenous at an infusion center, and the schedule is the same shape for every indication: an induction series at weeks 0, 2 and 6, then a maintenance infusion at a fixed interval. Maintenance is every 8 weeks for every indication except ankylosing spondylitis, which is every 6 weeks. The dose is weight-based: 5 mg/kg for Crohn's disease, ulcerative colitis (adult and pediatric, 6 and older), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, and 3 mg/kg for rheumatoid arthritis given with methotrexate.

Plan for a long appointment, and a recurring one. The label is explicit that "the infusion must be administered intravenously for at least 2 hours" through an in-line filter. That two-hour floor is the FDA-approved administration instruction, not a scheduling convention, and it is the infusion time alone — check-in, a weight measurement (dosing is mg/kg, so weight is recorded at every visit), vascular access, any premedication the prescriber has ordered, preparation of the drug and monitoring afterward all sit on top of it. After induction, most people return every 8 weeks — every 6 for ankylosing spondylitis — for years. It is worth booking around childcare, work and travel from the start.

One product distinction to avoid confusion: everything on this page concerns intravenous infliximab. Subcutaneous infliximab (Zymfentra) is a separate product with its own labeling, dispensed under the pharmacy benefit rather than administered in an infusion suite.

REMICADE and every infliximab biosimilar carry an FDA boxed warning — the strongest warning FDA requires — headed "WARNING: SERIOUS INFECTIONS and MALIGNANCY". It has two parts, and both belong in front of anyone starting this drug.

Serious infections

The label states that patients treated with REMICADE "are at increased risk for developing serious infections that may lead to hospitalization or death," and that most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. REMICADE "should be discontinued if a patient develops a serious infection or sepsis." The reported infections named in the boxed warning are:

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis "have frequently presented with disseminated or extrapulmonary disease." The label requires that patients "be tested for latent tuberculosis before REMICADE use and during therapy," and that "treatment for latent infection should be initiated prior to REMICADE use." Both halves matter: screening is not a one-time box to tick before the first infusion, and a positive latent test is treated first, not alongside.
• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. These may present as disseminated rather than localized disease, and antigen and antibody testing for histoplasmosis "may be negative in some patients with active infection." The label says empiric antifungal therapy should be considered in at-risk patients who develop severe systemic illness.
• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The warning directs that risks and benefits be carefully weighed before starting therapy in a patient with chronic or recurrent infection, and that patients be closely monitored for signs and symptoms of infection during and after treatment — "including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy."

Malignancy

"Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE."

The warning also describes postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare T-cell lymphoma reported in patients treated with TNF blockers including REMICADE. "These cases have had a very aggressive disease course and have been fatal." Almost all such patients had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis, and "the majority of reported REMICADE cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males." If that describes you or your child, it is a specific conversation to have with the gastroenterologist about combination therapy — not a reason to stop reading.

The full boxed warning, together with the Warnings and Precautions section, is in the prescribing information and on DailyMed. The Inflectra, Renflexis and Avsola labels carry the same boxed warning with the product name substituted; no infliximab product carries a lesser one.

In the label's own rheumatoid arthritis trial table — adverse reactions in at least 5% of patients receiving four or more infusions, REMICADE (n=1129) against placebo (n=350) — the most frequently reported were upper respiratory tract infection (32% vs 25%), nausea (21% vs 20%), headache (18% vs 14%), sinusitis (14% vs 8%), diarrhea (12% vs 12%), abdominal pain (12% vs 8%), pharyngitis (12% vs 8%), coughing (12% vs 8%), bronchitis (10% vs 9%), rash (10% vs 5%), dyspepsia (10% vs 7%), fatigue (9% vs 7%), urinary tract infection (8% vs 6%), arthralgia (8% vs 7%), pruritus (7% vs 2%), fever (7% vs 4%), hypertension (7% vs 5%) and moniliasis (5% vs 3%). As the label itself cautions, clinical trial rates are observed under widely varying conditions and cannot be compared directly with rates from other trials or with what happens in practice. These figures come from adult RA trials; pediatric rates are reported separately and should not be assumed to match.

Infusion reactions are the ones that happen in the chair. The label reports that "approximately 20% of REMICADE-treated patients experienced an infusion reaction compared with 10% of placebo-treated patients" — roughly one patient in five. Across all infusions, "3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria." Reactions occur during the infusion or within an hour after it. "Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension."

That is precisely why the label instructs that, prior to treatment, staff "ensure appropriate personnel and medication are available to treat reactions," that clinicians "consider slowing or stopping the infusion" for mild to moderate reactions, and that patients be monitored during the infusion and the infusion discontinued if a serious reaction occurs. Premedication with histamine-1 or histamine-2 receptor antagonists, acetaminophen and/or corticosteroids is something the label says patients may receive — it is a prescriber's order, not an automatic step. Tell the nursing staff immediately about any chest tightness, flushing, itching, breathlessness or feeling of unease during an infusion.

Prime Infusions accepts referrals for Remicade, Inflectra, Renflexis, Avsola and unbranded infliximab. Here is what actually separates them.

Remicade is the reference product, licensed under section 351(a) of the Public Health Service Act, initial U.S. approval 1998. Inflectra (infliximab-dyyb), Renflexis (infliximab-abda) and Avsola (infliximab-axxq) are biosimilars, licensed under section 351(k). FDA's patient-facing definition is that a biosimilar "is highly similar to a biologic medication already approved by FDA," and the biosimilar labels state approval is based on data showing "there are no clinically meaningful differences between [the biosimilar product] and the reference product." "Unbranded infliximab" is not a biosimilar. The unbranded infliximab marketed by Janssen Biotech is an unbranded version of Remicade itself — same product, no biosimilar suffix in its nonproprietary name, and no biosimilarity statement on its label. One commercial payer policy calls it "infliximab (authorized generic)."

No infliximab product carries FDA interchangeability. In the FDA Purple Book, Inflectra (BLA 125544, Celltrion, approved April 5, 2016), Renflexis (BLA 761054, Samsung Bioepis, April 21, 2017) and Avsola (BLA 761086, Amgen, December 6, 2019) are each listed as "351(k) Biosimilar," and none appears with an interchangeability designation on FDA's biosimilar product list. As FDA explains, "interchangeable" is a designation about whether a pharmacist may substitute without consulting the prescriber — subject to state law — not a statement that a product works better. New York's substitution statute, Education Law § 6816-a, is gated on exactly that designation, so its pharmacy-substitution pathway does not apply to infliximab at all.

In practice, infliximab is provider-administered under the medical benefit, not dispensed at a retail counter. The product a patient receives is the one the prescriber orders, interacting with the health plan's own preferred-product policy — there is no pharmacy substitution step in the workflow. Prime Infusions does not recommend one infliximab product over another; that choice belongs to the prescriber and the plan.

Prime Infusions has 13 infusion centers in New York, plus one in Atlanta. In New York City and the surrounding counties that means Brooklyn (Foster Avenue) and Boro Park in Brooklyn; Fresh Meadows, Astoria, Jamaica and Howard Beach in Queens; the Upper East Side in Manhattan; 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. All centers are open Monday to Friday, 9:00AM to 5:00PM. Addresses are on our locations page. Because an infliximab course runs on a fixed 6- or 8-week interval for years, the practical question is usually which center you can reach reliably on a weekday. Our care team confirms which location will administer your infusions — per-center product availability is not published, and it is a question worth asking before the first appointment is booked.

Which type of site is covered is a separate matter your plan decides. UnitedHealthcare's commercial policy "Provider Administered Drugs – Site of Care," Policy 2026D0121V, effective August 1, 2026, lists Remicade, Inflectra, Renflexis and Avsola expressly within scope and states that "alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion suites, or home infusion services are well accepted places of service for medication infusion therapy," and that where an individual does not meet criteria for outpatient hospital facility infusion, alternative sites of care may be used. Whether that policy applies to a particular patient is a determination only that patient's plan can make.

Physicians can send a referral through our Treatment Referrals directory or the Remicade request form. Patients and families can reach us at 718-443-4000 or through our contact page.

Expect prior authorization, and expect a step-therapy question about which infliximab product. Most patients assume the originator is the default. Under both national policies below, it is not.

UnitedHealthcare, Commercial Medical Benefit Drug Policy "Infliximab (Avsola, Inflectra, Remicade, & Renflexis)," Policy 2026D0004AR, effective February 1, 2026, names Inflectra and Avsola as its preferred products. To obtain Remicade, Renflexis or another non-preferred infliximab under medical-necessity plans, the policy asks for "documentation of a trial of at least 14 weeks of Inflectra or Avsola resulting in minimal clinical response to therapy and residual disease activity," plus prescriber attestation, or "documentation of intolerance, contraindication, or adverse event to Inflectra or Avsola."

Cigna, "Infliximab Intravenous Products Preferred Specialty Management Policy," Coverage Policy PSM005, effective 08/15/2026, likewise lists Avsola and Inflectra as preferred and "infliximab (authorized generic), Remicade, Renflexis" as non-preferred, directing the patient to try at least one preferred product before a non-preferred one is approved, on top of its standard prior-authorization criteria. So on both of these policies, Remicade — the originator — is the non-preferred product. This is a payer policy question your plan decides, not a clinical ranking; preferred-product lists change, and the two above are national policies, not New York-specific ones.

Medicare. Infliximab falls under Part B, not Part D, because it is administered by a clinician: CMS states Part B covers drugs "provided as part of (or incident to) a physicians' service" and "generally … only drugs that are not usually self-administered." Medicare pays ASP plus 6% for most separately payable Part B drugs; for biosimilars the limit is the biosimilar's ASP plus 6% of the reference biological's ASP, or plus 8% for qualifying biosimilars. The Medicare contractor billing article for infliximab and biosimilars (A52423) requires documentation including patient weight, tuberculosis evaluation and treatment initiated before therapy, and inadequate response to a three-month trial of conventional non-biologic therapy — so TB screening is both a safety step and a claims requirement.

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 no infusion provider can promise an approval.