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Important Safety Information | Prescribing Information | Patient Support | Celltrion USA | Patient Site

For US healthcare professionals only

Prescribing Information

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Important Safety Information | Prescribing Information | Patient Support | Celltrion USA | Patient Site

Mode of Delivery PK Profile Efficacy Safety Resources

ZYMFENTRA offers patients the convenience of at-home biweekly administration1

  • 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.

4 weeks after the last administration of IV infliximab, shift to biweekly administration of ZYMFENTRA

IFX IV induction schedule shifting to ZYMFENTRA maintenance

IV Induction Chart ZYMFENTRA™

After the last administration of IV infliximab, shift to biweekly ZYMFENTRA in place of the next scheduled IV infusion

IFX IV maintenance schedule shifting to ZYMFENTRA maintenance

IFX IV Maintenance Schedule
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ZYMFENTRA offers a streamlined treatment regimen that liberates patients from infusion burdens1

Zymfentra Pen Attributes Diagram

ZYMFENTRA offers a streamlined treatment regimen that liberates patients from infusion burdens1

ZYFMENTRA gives patients increased flexibility and convenience through self-administration—more freedom, less restraints

The only subcutaneous infliximab formulation approved by the FDA1,2

Increased flexibility and convenience with biweekly administration

Convenient 2-step injection process

Statistically significant clinical improvements compared to placebo1*

Sterile, preservative-free, citrate-free solution

Does not contain natural rubber latex

If needed, store the prefilled pen at room temperature† for up to 14 days, protected from light

The product must be discarded if not used within the 14 days

Zymfentra Pen Vertical

⁎At Week 54, 63% of patients with CD and 43% with UC achieved clinical remission (30% and 21% for placebo, respectively)1

†Room temperature is defined as 68°F to 77°F (20°C to 25°C)

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How to inject ZYMFENTRA

Play this video for step-by-step instructions on how your patients or their caregivers should inject ZYMFENTRA.

Storage and handling1

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

IFX=infliximab; IV=intravenous.

References: 1. ZYMFENTRA™ Prescribing Information, Celltrion, Inc., 2024. Celltrion USA, Inc.  2. Data on file. Celltrion, Inc. 

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. 

Carefully consider the risks and benefits of treatment with ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection.

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.

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.

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.

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. 

Carefully consider the risks and benefits of treatment with ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection.

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.

Please see full Prescribing Information, including BOXED WARNING.

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.

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This site is intended for US audiences only. Models are used for illustrative purposes only. Not actual patients.
ZYMFENTRA™ is a trademark of Celltrion, Inc., used under license.
©Celltrion USA, Inc. 2024 US-ZYM-24-00334 06/24

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