Prescription medicine
Infliximab-dyyb Brand names: Zymfentra; first approved as Inflectra
Infliximab-dyyb (Inflectra) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the infliximab-dyyb FDA label on DailyMed (effective August 18, 2026, CELLTRION USA Inc.); the BLA 125544 record on Drugs@FDA; every infliximab-dyyb label on DailyMed.
Highlights of the record
FDA label of August 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. […]
Used for
From the label: indications and usageZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
Forms and strengths
- 120 mg/ml
Injection; kit.
On the market
- Earliest approval on file
- April 5, 2016 Inflectra, Celltrion Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 29,059 through July 30, 2026
What is infliximab-dyyb used for?
From the label: indications and usageZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (ZYMFENTRA), CELLTRION USA Inc., effective August 18, 2026 (SPL set 93a193ab-9f96-4da6-aa7c-31212e81879a), via openFDA; the full label on DailyMed
What does the patient leaflet for infliximab-dyyb say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZYMFENTRA ?ZYMFENTRA may cause serious side effects, including: 1. Risk of infection ZYMFENTRA is a medicine that affects your immune system. ZYMFENTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving ZYMFENTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before starting ZYMFENTRA. Your doctor should monitor you closely for signs and symptoms of TB during treatment with ZYMFENTRA. Before starting ZYMFENTRA, tell your doctor if you: think you have an infection. You should not start receiving ZYMFENTRA if you have any kind of infection. are being treated for an infection. have signs of an infection, such as a fever, cough, flu-like symptoms. have any open cuts or sores on your body. get a lot of infections or have infections that keep coming back. have diabetes or an immune system problem as people with these conditions have a higher chance for getting infections. have TB, or have been in close contact with someone with TB. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis); these infections may develop or become more severe if you receive ZYMFENTRA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor. have or have had hepatitis B. use the medicines KINERET (anakinra), ORENCIA (abatacept), or other medicines called biologics used to treat the same conditions as ZYMFENTRA. […]
From the patient leaflet: What should I avoid while taking ZYMFENTRA?Do not take ZYMFENTRA together with other medicines medicines called biologics that are used to treat the same conditions as ZYMFENTRA. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn's disease, or ulcerative colitis. Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
From the patient leaflet: How should I store ZYMFENTRA?Store ZYMFENTRA prefilled syringes and prefilled pens in a refrigerator between 36°F to 46°F (2°C to 8°C). If needed, ZYMFENTRA prefilled syringes and prefilled pens may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days with protection from light. When ZYMFENTRA prefilled syringes and prefilled pens have reached room temperature, do not put ZYMFENTRA back in the refrigerator. ZYMFENTRA must be thrown away (discarded) if not used within the 14 days. Do not freeze ZYMFENTRA. Do not shake ZYMFENTRA. Keep ZYMFENTRA in the original carton until ready to use to protect it from light.
Source: FDA drug label (ZYMFENTRA), CELLTRION USA Inc., effective August 18, 2026 (SPL set 93a193ab-9f96-4da6-aa7c-31212e81879a), via openFDA; the full label on DailyMed
Is there a generic for infliximab-dyyb (Inflectra)?
No generic infliximab-dyyb is approved (Drugs@FDA, October 8, 2026).
- 2016 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the infliximab-dyyb label say about other medicines?
The infliximab-dyyb label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | warnings and precautions | Infection with Concurrent Administration with Other Biological Products Serious infections and neutropenia have been reported with concurrent use of TNF-blockers and other immunosuppressive biological products (e.g., anakinra and abatacept). |
| Anakinra | warnings and precautions | Infection with Concurrent Administration with Other Biological Products Serious infections and neutropenia have been reported with concurrent use of TNF-blockers and other immunosuppressive biological products (e.g., anakinra and abatacept). |
| Azathioprine | boxed warning | Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of TNF blockers, including ZYMFENTRA, in patients being treated with CYP450 substrates requiring therapeutic drug monitoring, monitor therpeutic parameters (e.g., INR for warfarin) or drug concentration (e.g., cyclosporine or theophylline). |
| Infliximab | boxed warning | Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. … |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Theophylline | drug interactions | Upon initiation or discontinuation of TNF blockers, including ZYMFENTRA, in patients being treated with CYP450 substrates requiring therapeutic drug monitoring, monitor therpeutic parameters (e.g., INR for warfarin) or drug concentration (e.g., cyclosporine or theophylline). |
| Warfarin | drug interactions | Upon initiation or discontinuation of TNF blockers, including ZYMFENTRA, in patients being treated with CYP450 substrates requiring therapeutic drug monitoring, monitor therpeutic parameters (e.g., INR for warfarin) or drug concentration (e.g., cyclosporine or theophylline). |
Source: FDA drug label (ZYMFENTRA), CELLTRION USA Inc., effective August 18, 2026 (SPL set 93a193ab-9f96-4da6-aa7c-31212e81879a), via openFDA; the full label on DailyMed
What do FAERS reports show for infliximab-dyyb?
The FDA Adverse Event Reporting System holds 29,059 reports that list infliximab-dyyb among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 703 are coded as a death and 7,127 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Infliximab-dyyb side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other