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Frequently Asked Questions

What is ZYMFENTRA?1

ZYMFENTRA 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 
  • moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously

What warnings and precautions are associated with ZYMFENTRA?1

  • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens
  • Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis
  • 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
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products
  • 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

What are the contraindications for ZYMFENTRA?1

  • ZYMFENTRA is contraindicated in patients with a history of a severe hypersensitivity reaction to other infliximab products, any of its ingredients, or any murine proteins. Reactions have included anaphylaxis.

What clinical studies support the efficacy and safety of ZYMFENTRA?1

The safety and efficacy of ZYMFENTRA were assessed in two 54-week randomized, double-blind, placebo-controlled clinical trials:

  • UC Trial I: adult subjects with moderately to severely active UC (defined as a modified Mayo score between 5 to 9 with an endoscopic subscore of 2 or 3)
  • CD Trial I: adult subjects with moderately to severely active CD, defined as Crohn’s Disease Activity Index score of 220 to 450 points, and a centrally reviewed Simplified Endoscopic Activity Score for Crohn’s Disease of ≥6 points for ileal-colonic CD (or ≥4 points for isolated ileal disease)
See the Efficacy Data

Has ZYMFENTRA been studied as monotherapy?2

Yes. In a post hoc analysis of the LIBERTY-CD and LIBERTY-UC studies patients received ZYMFENTRA with or without immunosuppressants.

See the Data

Does monotherapy affect immunogenicity or safety?2

Median ADA titers were similar between monotherapy and combination therapy. No meaningful differences in serious adverse events were observed.

See the Safety Data

How durable is ZYMFENTRA over time?2

In 2-year follow-up from LIBERTY study extensions:

  • Drug levels with SC ZYMFENTRA remained above therapeutic thresholds through Week 102
  • Efficacy endpoints—including clinical remission—were maintained
See the 2-Year Data

What were the most common adverse reactions reported with ZYMFENTRA?1

The most common adverse reactions reported in ≥3% of subjects and at a higher rate than placebo in UC Trial I were: COVID-19, anemia, arthralgia, injection-site reaction, increased alanine aminotransferase, and abdominal pain.

The most common adverse reactions reported in ≥3% of subjects and at a higher rate than placebo in CD Trial I were: COVID-19, headache, upper respiratory tract infection, injection-site reaction, diarrhea, increased blood creatinine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia.

See the Safety Data

What’s important to know about the pharmacokinetic profile of ZYMFENTRA?1

ZYMFENTRA, the only FDA-approved subcutaneous (SC) formulation of infliximab, offers consistent steady and stable infliximab trough levels in patients with UC and CD.

How does ZYMFENTRA compare to IV infliximab in terms of drug exposure?2

In a head-to-head study, ZYMFENTRA (SC infliximab 120 mg every 2 weeks) demonstrated higher and more stable serum drug levels than IV infliximab 5 mg/kg every 8 weeks.

  • SC IFX maintained consistent levels throughout the dosing cycle
  • IV IFX showed a peak-and-trough pattern with declining concentrations between infusions
See the PK Data

What is the recommended dosing for ZYMFENTRA?1

ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter: 120 mg subcutaneously once every 2 weeks. To shift patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFENTRA in place of the next scheduled intravenous infusion and every 2 weeks thereafter. ZYMFENTRA is intended for use under the guidance and supervision of a healthcare professional. If a healthcare professional determines that it is appropriate, patients may self-inject ZYMFENTRA. All patients must complete an intravenous induction regimen with an infliximab product before starting ZYMFENTRA.

What are the benefits of SC administration for my patients?1

ZYMFENTRA is designed for long-term self-administration:

  • SC dosing every 2 weeks using a prefilled syringe or autoinjector
  • ~30-second injection time
  • At-home administration—no need for infusion centers
  • Room temperature stability for up to 14 days

These features may reduce infusion burden, improve convenience, and support adherence.

What is the mechanism of action for ZYMFENTRA?1

Infliximab-dyyb neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab-dyyb has shown biological activities, such as TNFα neutralization activity and TNFα binding affinities, complement component 1q (C1q) binding affinity and crystallizable fragment (Fc) receptor binding affinities in a wide variety of in vitro bioassays. The relationship of these biological response markers to the mechanism(s) by which infliximab-dyyb exerts its clinical effects is unknown.

What type of patient support is available for my patients prescribed ZYMFENTRA?

The Celltrion CONNECT® Patient Support Program provides ongoing support to patients prescribed ZYMFENTRA. For details on program benefits, click here.

How should ZYMFENTRA be stored?1

Store ZYMFENTRA refrigerated at 36°F to 46°F (2°C to 8°C). If needed, ZYMFENTRA may be stored at room temperature at 68°F to 77°F (20°C to 25°C) for up to 14 days. Once ZYMFENTRA has been stored at room temperature, it should not be placed back into the refrigerator. Discard ZYMFENTRA if not used within the 14 days. DO NOT FREEZE. Keep the product in its outer carton until time of administration in order to protect from light.

LEARN MORE ABOUT ZYMFENTRA

References: 1. ZYMFENTRA Prescribing Information. Celltrion USA, Inc; 2024. 2. Schreiber S, Colombel J-F, Hanauer SB, et al. Comparing outcomes with subcutaneous infliximab (CT-P13 SC) by baseline immunosuppressant use: A post hoc analysis of the LIBERTY-CD and LIBERTY-UC studies. Inflamm Bowel Dis. Published online April 30, 2025. doi: 10.1093/ibd/izaf038

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with TNF blockers, including ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, 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 infliximab products.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in young adult males.

Contraindications

  • ZYMFENTRA is contraindicated in patients with a history of a severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA, or any murine proteins. Reactions have included anaphylaxis.

Warnings and Precautions

  • Serious infections: Avoid in patients with active infection. If infection develops, conduct a prompt/complete diagnostic workup appropriate for immunocompromised patients and initiate antimicrobials. If systemic illness develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungals.
  • Malignancies: Malignancies, including lymphoma, were greater in TNF-blocker-treated patients. Consider the higher risk of hepatosplenic T-cell lymphoma (HSTCL) with combination therapy versus increased risk of immunogenicity and hypersensitivity reactions with monotherapy.
  • Hepatitis B virus (HBV) reactivation: Test for HBV infection before starting treatment. Monitor HBV carriers during and several months after therapy for active HBV infection. If reactivation occurs, stop ZYMFENTRA and begin anti-viral therapy.
  • Hepatotoxicity: Severe hepatic reactions, some fatal or necessitating liver transplantation have occurred in patients receiving infliximab products. Monitor hepatic enzymes and liver function tests every 3-4 months during treatment; investigate liver enzyme elevations and interrupt treatment if drug-induced liver injury is suspected. Instruct patients to seek immediate medical attention if symptoms develop.
  • Congestive heart failure (CHF): New onset or worsening symptoms may occur. Avoid in patients with CHF. Monitor for new/worsening symptoms when administering ZYMFENTRA.
  • Hematologic reactions: Advise patients to seek immediate medical attention if signs and symptoms of cytopenia develop; consider stopping if significant hematologic abnormalities develop.
  • Hypersensitivity and other administration reactions: Serious hypersensitivity reactions, including anaphylaxis have occurred with intravenous formulations of infliximab; discontinue ZYMFENTRA and start appropriate therapy.
  • Neurologic reactions: Exacerbation or new onset CNS demyelinating disorders may occur; consider discontinuation of ZYMFENTRA.
  • Risk of infection with concurrent administration of other biological products: Concurrent use with other immunosuppressive biologics may increase risk of infection.
  • Risk of additive immunosuppressive effects from prior biological products: Consider the half-life and mode of action of prior biologics.
  • Autoimmunity: Formation of autoantibodies and development of lupus-like syndrome may occur; discontinue ZYMFENTRA if symptoms develop.
  • Vaccinations and use of live vaccines/therapeutic infectious agents: Prior to initiating ZYMFENTRA bring patients up to date with vaccinations. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA. A 6-month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab.

Common Adverse Reactions (≥3%)

  • Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.
  • Crohn's Disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia.

Drug Interactions

  • Concurrent use with immunosuppressive biologics used to treat UC and CD is not recommended due to risk of infection.
  • Formation of CYP450 enzymes may be suppressed by increased levels of cytokines during chronic inflammation. ZYMFENTRA could normalize the formation of CYP450 enzymes potentially resulting in decreased exposure of CYP450 substrates and requiring dose adjustments.

INDICATIONS

Crohn's Disease

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.

Ulcerative Colitis

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

Please see full Prescribing Information, including BOXED WARNING.

INDICATIONS

Crohn's Disease

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.

Ulcerative Colitis

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS and MALIGNANCY

SERIOUS INFECTIONS

Patients treated with TNF blockers, including ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, 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 infliximab products.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in young adult males.

Contraindications

  • ZYMFENTRA is contraindicated in patients with a history of a severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA, or any murine proteins. Reactions have included anaphylaxis.

Warnings and Precautions

  • Serious infections: Avoid in patients with active infection. If infection develops, conduct a prompt/complete diagnostic workup appropriate for immunocompromised patients and initiate antimicrobials. If systemic illness develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungals.
  • Malignancies: Malignancies, including lymphoma, were greater in TNF-blocker-treated patients. Consider the higher risk of hepatosplenic T-cell lymphoma (HSTCL) with combination therapy versus increased risk of immunogenicity and hypersensitivity reactions with monotherapy.
  • Hepatitis B virus (HBV) reactivation: Test for HBV infection before starting treatment. Monitor HBV carriers during and several months after therapy for active HBV infection. If reactivation occurs, stop ZYMFENTRA and begin anti-viral therapy.
  • Hepatotoxicity: Severe hepatic reactions, some fatal or necessitating liver transplantation have occurred in patients receiving infliximab products. Monitor hepatic enzymes and liver function tests every 3-4 months during treatment; investigate liver enzyme elevations and interrupt treatment if drug-induced liver injury is suspected. Instruct patients to seek immediate medical attention if symptoms develop.
  • Congestive heart failure (CHF): New onset or worsening symptoms may occur. Avoid in patients with CHF. Monitor for new/worsening symptoms when administering ZYMFENTRA.
  • Hematologic reactions: Advise patients to seek immediate medical attention if signs and symptoms of cytopenia develop; consider stopping if significant hematologic abnormalities develop.
  • Hypersensitivity and other administration reactions: Serious hypersensitivity reactions, including anaphylaxis have occurred with intravenous formulations of infliximab; discontinue ZYMFENTRA and start appropriate therapy.
  • Neurologic reactions: Exacerbation or new onset CNS demyelinating disorders may occur; consider discontinuation of ZYMFENTRA.
  • Risk of infection with concurrent administration of other biological products: Concurrent use with other immunosuppressive biologics may increase risk of infection.
  • Risk of additive immunosuppressive effects from prior biological products: Consider the half-life and mode of action of prior biologics.
  • Autoimmunity: Formation of autoantibodies and development of lupus-like syndrome may occur; discontinue ZYMFENTRA if symptoms develop.
  • Vaccinations and use of live vaccines/therapeutic infectious agents: Prior to initiating ZYMFENTRA bring patients up to date with vaccinations. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA. A 6-month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab.

Common Adverse Reactions (≥3%)

  • Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.
  • Crohn's Disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia.

Drug Interactions

  • Concurrent use with immunosuppressive biologics used to treat UC and CD is not recommended due to risk of infection.
  • Formation of CYP450 enzymes may be suppressed by increased levels of cytokines during chronic inflammation. ZYMFENTRA could normalize the formation of CYP450 enzymes potentially resulting in decreased exposure of CYP450 substrates and requiring dose adjustments.

INDICATIONS

Crohn's Disease

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.

Ulcerative Colitis

  • ZYMFENTRA is indicated in adults for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

Please see full Prescribing Information, including BOXED WARNING.