Zymfentra
infliximab-dyyb · Kit · Subcutaneous
Uses
1 INDICATIONS AND USAGE 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. ( 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.
Dosage and administration
Important Dosage Information. ( 2.1 ). ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All pateitns must complete an intravenous induction regiemen with an infliximab product before starting ZYMFENTRA. ZYMFENTRA is for subcutaneous use only. Recommeneded Maintenance Dosage in Ulcerative Colitis and Crohn's Direase ( 2.2 ) Week 10 and thereafter : Inject 120 mg subcutaneously once every two weeks. To swift 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 two weeks thereafter. See the full prescribing information on how to administer subcutaneously. ( 2.3 ) 2.1 Important Dosage Information ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All patients mush coplete an intravenous induction regimen with an infliximab product before starting ZYMFENTRA. For induction dosing information, see the corresponding full prescribing information for the chosen infliximab product. ZYMFENTRA is for subtutaneous use only. 2.2 Recommeneded Dosage for Maintenance Treatment in Ulcerative Colitis Crohn's Disease Maintenance dosage starting at Week 10 and thereafter: 120 mg subcutaneously once every two weeks. To switch patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFNETRA in place of the next scheuled intravenous infusion and every two weeks thereafter. 2.3 Subcutaenous Administration Instructions 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-injection ZYMFENTRA or caregivers may injection ZYMFENTRA using either the ZYMFENTRA prefilled syringe, ZYMFENTRA prefilled syringe with needle guard, or ZYMFENTRA prefilled pen after proper training in subcutaenous injection technique. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whether solution and container permit. ZYMFENTRA should be a clear, colorless to pale brwon solution. Do not use if particulates or discoloration is presnet. Inject into the front of the tights, the abdomen excepts for the 2 inches around the navel, or the outer area of the upper arms (caregiver only). Rotate the injectoin site each time an inejction is given. Allow at least 1.2 inches between the new injection site and the previous inejction site. Never inject into areas where the skin is red, bruised, tender, or indurated. Do not use the syringe or pen of it has been dropped or is visibly damaged. A damaged syringe may not function proprely. Do not resue or shake the syringe or pen at any time. Mixed Dose If an injection of ZYMFENTRA is missed, inject the next subcutaneous dose as soon as possible and then every two weeks thereafter.
Dosage forms and strengths
(infliximab-dyyb) is a clear, colorless to pale brown solution available as follow: Injection: 120 mg/mL in a single-dose prefilled syringe. Injection: 120 mg/mL in a single-dose prefilled syringe with needle guard. Injection: 120 mg/mL in a single-dose prefilled pen. Injection ( 3 ): 120 mg/mL in a single-dose prefilled syringe. 120 mg/mL in a single-dose prefilled syringe with needle guard. 120 mg/mL in a single-dose prefilled pen.
Contraindications
4 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 [ see Warnings and Precautions ( 5.7 ) ]. History of severe hypersentitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA or to any murine proteins. ( 4 )
Warnings and precautions
Serious injections, including invasive fungal infections: Avoid use of ZYMFENTRA in patients with an active infection. If infection develops during treatment, conduct a prompt and complete diagnostic workup appropriate for an immunocompromised patient and initiate antimicrobial therapy. If systemic illness develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungal therapy. ( 5.1 ) Malignancies : The incidence of malignancies, including lymphoma, was greater in TNF blocker-treated patients than in controls. Consider the higher risk of hepatosplenic T-cell lymphoma (HSTCL) with combination therapy versus increased tisk of immunogenicity and hypersensitivity reactions with monotherapy. ( 5.2 ) Hepatitis B virus (HBV) reactivation: Test for HBV infection before starting ZYMFENTRA. Monitor HBV carriers during and several months after therapy for active HBV infection. If reactivation occurs, stop ZYMFENTRA and begin anti-viral therapy. ( 5.3 ) Hepatotoxicity: Severe hepatic reactions, some fatal or necessitating liver transplantation with infliximab products. Monitor hepatic enzymes and liver function tests every 3 to 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. ( 5.4 ) Congestive heart failure (CHF) : New onset or worsening symptoms may occur. Avoid ZYMFENTRA in patients with CHF. Monitor for new or worsening symptoms if a decision is made to administer ZYMFENTRA. ( 5.5 ) Hematologic Reactions : Advise patients to seek immediate medical attention if signs and symtoms of cytopenia develop; consider stopping ZYMFENTRA if significant hematologic abnormalities devlop. ( 5.6 ) Hypersensitivity and Other Administration Reactions : Serious systemic hypersensitivity reactions including anaphylaxis; institute appropriate therapy and discontinue ZYMFENTRA. ( 4 , 5.7 ) Neurologic Reactions : Exacerbation or new onset CNS demyelinating disorders may occurs; consider discontinuation of ZYMFENTRA. ( 5.8 ) Risk of infection with concurrent administration of other biological products : Concurrent use with other immunosuppressive biological products may increase the risk of injection ( 5.9 ) Risk of additive immunosuppressive effects from prior biologic products : Consider the half-life and mode of action of prior biological products. ( 5.10 ) Autoimmunity : Formation of autoantibodies and development of lupus-like syndrome may occur; discontinue ZYMFENTRA if symptoms develop. ( 5.11 ) V accinations and Use of Live Vaccines/Therapeutic Infectious Agents: Prior to initiating ZYMFENTRA bring patients up to date with all 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 products. ( 5.12 ) 5.1 Serious Infections Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease. Treatment with ZYMFENTRA should not be initiated in patients with an active infection, including clinically important localized infections.Patients greater than 65 years of age, patients with comorbid-conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with infliximab products during treatment for latent tuberculosis. Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating ZYMFENTRA and periodically during therapy. Treatment of latent tuberculosis infection prior to therapy with TNF blockers has been shown to reduce the risk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating ZYMFENTRA even for patients previously vaccinated with Bacille Calmette-Guérin (BCG). Consider anti-tuberculosis therapy prior to initiation of ZYMFENTRA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious infections [ see Warnings and Precautions ( 5.1 ) ] Malignancies [ see Warnings and Precautions ( 5.2 ) ] Hepatitis B virus reactivation [ see Warnings and Precautions ( 5.3 ) ] Hepatotoxicity [ see Warning and Precautions ( 5.4 ) ] Congestive heart failure [ see Warnings and Precautions ( 5.5 ) ] Hematologic reactions [ see Warnings and Precautions ( 5.6 ) ] Hypersensitivity and other administration reactions [ see Warnings and Precautions ( 5.7 ) ] Neruologic reactions [ see Warnings and Precautions ( 5.8 ) ] Autoimmunity [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain. ( 6.1 ) 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to ZYMFENTRA in 518 adult subjects in two 54-weekrandomized, double-blind, placebo-controlled trials in subjects with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) (UC Trial I an CD Trial I). Subject who achieved clinical response following three induction doses of infliximab-dyyb administered as an intravenous infusion at Week 0, 2 and 6 were randomized 2:1 to ZYMFENTRA 120 mg or placebo as a subcutaneous injection every two weeks at Week 10 [ see Clinical Studies ( 14.1 and 14.2 )]. Ulcerative Colitis The most common adverse reactions reported in ≥3% of subjects and at a higher rate than Placebo in UC Trial I are shown in Table 1. Table 1 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind 54-Week Study of Subjects with UC (UC Tral I) ZYMFENTRA 120 mg Subcutaneous Injection b N=296 (%) Placebo N=140 (%) COVID-19 10 6 Anemia d 5 4 Arthralgia 4 1 Injection site reaction # 3 2 Increased alanine aminotransferase 3 1 Abominal pain f 3 1 a reported in at least 3% of ZYMFENTRA-treated subjects and at a higher than placebo b ZYMFENTRA 120 mg as a subcutaneous injection every two weeks starting Week 10 following 3 intravenous induction doses of inflixiab-dyyb c Includes: COVID-19 and COVID-19 pneumonia d Includes: anemia and iron deficiency anemia # Some subjects had multiple occurences of injection site reactions. In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus and swelling. f Includes: abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort Crohn's Disease The most common adverse reactions reported in ≥3% of subjects and at a higher rate than placebo in CD Trial I are shown in Table 2. Table 2 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind 54-Week Study of Subjects with CD (CD Trial I) ZYMFENTRA 120 mg Subcutaneous Injection b N=222 (%) Placebo N=101 (%) COVID-19 10 5 Headache 8 4 Upper respiratory track infectionsd c 7 3 Injection site reaction d 5 1 Diarrhea 5 1 Increased blood creatine phosphokinase 4 2 Arthralgia 4 3 Increased alaine aninotransferase 4 1 Hypertensions e 3 2 Urinary track infection f 3 2 Neutropenia 3 0 Dizziness 3 0 Leukopenia 3 0 a reported in at least 3% of ZYMFENTRA-treated subjects and at a higher rate than placebo b ZYMFENTRA 120 mg administered subcutaneously starting at Week 10 and every 2 weeks thereafter for up to Week 54. c Includes: upper respiratory tract infection, acute sinusitis, chronic sinusitis, influenza like illness, nasopharyngitis, pharyngitis, pharyngitis streptococcal, rhinitis, rhinorrhea, rhinovirus infection, sinusitis, tonsillitis d Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus, rash, swelling, warmth. e Includes: hypertension and essential hypertension f Includes: urinary tract infection, pyelonephritis Adverse Evetns of Special Interest Infections In UC Trial I, at leaset one serious infection was reported in 3% of ZYMFENTRA-treated subjects compared to 1% in the plaebo group. Serious infections in the ZYMFENTRA-treated subjects were COVID-19, cystitis, pneumonia, salpingitis, and urinary tract injection [ see Warnings and Precautions ( 5.1 ) ]. In CD Trial I, infections were observed in 30% of ZYMFENTRA-treated subjects compare to 187% of placebo-treated subjects. At least one serious infection was reported in 3% of ZYMFENTRA-treated subjects compared to 1% in the placebo group. Serious infections in the ZYMFENTRA-treated subjects were abscess, appendicitis, bacterial arthritis, bartholinitis, bronchiolitis, and urinary tract infection [ see Warnings and Precautions ( 5.1 ) ]. Malignancies In UC Trial I, malignancy (prostate cancer) was reported in a ZYMFENTRA-treated subject. No malignancies were reported among placebo-treated subjects [ see Warnings and Precautions ( 5.2 ) ]. In another clinical trial in patients with CD, one malignancy (non-small cell lung cancer) was reported in a ZYMFENTRA-treated subject [ see Warnings and Precautions ( 5.2 ) ].
Drug interactions
7.1 Other Biological Products Used to Treat UC and CD The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended [ see Warnings and Precautions ( 5.9 ) ]. Consier the half-life and mode of action of prior biologial products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA [ see Warnings and Precautions ( 5.10 ) ]. 7.2 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, ZYMFENTRA, an antagonist of TNFα, could normalize the formation of CYP450 enzymes potentially resulting in a decrease in exposure of CYP450 substrates. 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). Dosage adjustment may be needed to maintain drug concentrations or parameters within the therapeutic range. See prescribing information for specific drugs. 7.3 Live Vaccines/Therapeutic Infectious Agents It is recommended that live vaccines not be given concurrently with ZYMFENTRA. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab products for 6 months following birth [ see Warnings and Precautions ( 5.12 ) ]. It is recommended that therapeutic infectious agents not be given concurrently with ZYMFENTRA [ see Warnings and Precautions ( 5.12 ) ].
Use in specific populations
8.1 Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with ZYMFENTRA are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy ( see Clinical Considerations ). Available observational data in pregnant women exposed to infliximab products administered intravenously showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. Most TNF blockers, such as infliximab products, administered intravenously are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Infants exposed in utero should not be administered live vaccines for at least 6 months after birth ( see Clinical Considerations ). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. Fetal/Neonatal Adverse Reactions The risk of fetal/neonatal adverse reactions with in utero exposure to infliximab-dyyb administered subcutaneously is unknown. However, most TNF blockers, such as infliximab products, cross the placenta and have been detected in infant serum up to 6 months following birth. Consequently, infants exposed to infliximab products may be at increased risk of infection, including disseminated infection which can become fatal. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to intravenous infliximab in utero [ see Warnings and Precautions (5.12) ]. Cases of agranulocytosis in infants exposed to intravenous infliximab in utero have also been reported. Therefore, ZYMFENTRA, administered during pregnancy may affect immune responses in the in utero-exposed newborn and infant [ see Adverse Reactions 6.2 ]. Data Animal Data Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA. 8.2 Lactation Risk Summary There are no data on the presence of infliximab-dyyb or its metabolites in either human or animal milk, the effects on the breastfed infant, or the effects on milk production after subcutaneous administration. Published literature show that infliximab is present at low levels in human milk after intravenous administration. Systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZYMFNETRA and any potential adverse effects on the brestfed child from ZYMFENTRA or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness in pediatric patients have not been established. 8.5 Geriatirc Use Clinical trials of ZYMFENTRA did not include sufficient numbers of sugjects aged 65 and over (8 subjects with UC and 6 subjects with CD) to determined whether they respond differently from younger subjects.
Pregnancy
8.1 Pregnancy Risk Summary Available data from reports of pregnancy in clinical trials with ZYMFENTRA are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy ( see Clinical Considerations ). Available observational data in pregnant women exposed to infliximab products administered intravenously showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. Most TNF blockers, such as infliximab products, administered intravenously are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Infants exposed in utero should not be administered live vaccines for at least 6 months after birth ( see Clinical Considerations ). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. Fetal/Neonatal Adverse Reactions The risk of fetal/neonatal adverse reactions with in utero exposure to infliximab-dyyb administered subcutaneously is unknown. However, most TNF blockers, such as infliximab products, cross the placenta and have been detected in infant serum up to 6 months following birth. Consequently, infants exposed to infliximab products may be at increased risk of infection, including disseminated infection which can become fatal. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to intravenous infliximab in utero [ see Warnings and Precautions (5.12) ]. Cases of agranulocytosis in infants exposed to intravenous infliximab in utero have also been reported. Therefore, ZYMFENTRA, administered during pregnancy may affect immune responses in the in utero-exposed newborn and infant [ see Adverse Reactions 6.2 ]. Data Animal Data Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.
Pediatric use
8.4 Pediatric Use The safety and effectiveness in pediatric patients have not been established.
Geriatric use
8.5 Geriatirc Use Clinical trials of ZYMFENTRA did not include sufficient numbers of sugjects aged 65 and over (8 subjects with UC and 6 subjects with CD) to determined whether they respond differently from younger subjects.
Description
Infliximab-dyyb, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 145.9 kDa. Infliximab-dyyb is produced by a recombinant murine myeloma cell line, SP2/0. ZYMFENTRA (inifliximab-dyyb) injection for subcutaneous use is a sterile, preservative-free, clear to opalescent, colorless to pale brown solution. ZYMFENTRA is supplied in a single-dose prefilled syringe with 29 gauge fixed 1/2 inch needle, prefilled syringe with 29 gauge fixed 1/2 inch needle with needle guard, or prefilled pen with 27 gauge fixed 1/2 inch needle. Each mL of solution contains 120 mg infliximab-dyyb, acetic acid (0.19 mg), polysorbate 80 (0.5 mg), sodium acetate (0.56 mg), sorbitol (45 mg) and Water for Injection, USP. The pH is 5.0.
Mechanism of action
12.1 Mechanism of Action Infliximab-dyyb neutralize 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 1q (C1q) binding affinity and crystallizable fragment (Fc) receptor binding affinities in a wide variety of in vitro bioasays. The relationship of these biological response markers to the mechanism(s) by which infliximab-dyyb exerts its clinical effects is unknown.
How supplied
How Supplied ZYMFENTRA (Infliximab-dyyb) injection for subcutaneous use is supplied as a sterile, preservative-free, clear to opalescent, colorless to pale brown solution in a single-use prefilled syringe, prefilled syringe with needle guard or prefilled pen. The syringe is fitted with a needle shield which are not made with natural rubber latex or any derivatives from natural rubber latex in any ingredient. Prefilled Syringe Each prefilled syringe is equipped with a 29 gauge fixed 1/2 inch needle with a rigid needle shield and a plunger stopper. The following configurations are available: One prefilled syringe (120 mg/mL solution) and one dose tray with two alcohol pads. (NDC: 72606-025-05) Two prefilled syringes (120 mg/mL solution) and two dose trays with two alcohol pads. (NDC: 72606-025-06) Four prefilled syringes (120 mg/mL solution) and four dose trays with four alcohol pads. (NDC: 72606-025-07) Six prefilled syringes (120 mg/mL solution) and six dose trays with six alcohol pads. (NDC: 72606-025-08) Prefilled Syringe with Needle Guard Each prefilled syringe is equipped with a 29 gauge fixed 1/2 inch needle with a rigid needle shield and an automatic needle guard, and a plunger stopper. The following configurations are available: One prefilled syringe with needle guard (120 mg/mL solution) and one does tray with two alcohol pads. (NDC: 72606-025-09) Two prefilled syringes with needle guard (120 mg/mL solution) and two dose trays with two alcohol pads. (NDC: 72606-025-10) Four prefilled syringes with needle guard (120 mg/mL solution) and four dose trays with four alcohol pads. (NDC: 72606-025-11) Six prefilled syringes with needle guard (120 mg/mL solution) and six dose trays with six alcohol pads. (NDC: 72606-025-12) Prefilled Pen Each prefilled pen is equipped with a 27 gauge fixed 1/2 inch needle with a rigid needle shield and a plunger stopper. The following configurations are available: One prefilled pen (120 mg/mL solution) and one dose tray with two alcohol pads. (NDC: 72606-025-01) Two prefilled pens (120 mg/mL solution and two dose trays with two alcohol pads. (NDC: 72606-025-02) Four prefilled pens (120 mg/mL solution) and four dose trays with four alcohol pads. (NDC: 72606-025-03) Six prefilled pens (120 mg/mL solution) and six dose trays with six alcohol pads. (NDC: 72606-025-04) Storage and Handling Store in refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Keep the product in its outer carton until time of administration in order to protect from light. 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 with protection from light. 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.
Patient information
Advise the patient or thier caregiver to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). Patients or their caregivers should be advised of the potential benefits and risks of ZYMFENTRA. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting ZYMFENTRA therapy and to reread it each time they receive an injection. Infections Inform patients that ZYMFENTRA increases the risk for developing serious infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of an infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [ see Warnings and Precautions ( 5.1 , 5.3 ) ]. Malignancies Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers. Patients should be counseled about the risk of lymphoma and other malignancies while receiving ZYMFENTRA [ see Warnings and Precautions ( 5.2 ) ]. Hepatotoxicity Instruct patients to seek medical attention if they develop signs or symptoms of hepatotoxicity (e.g., jaundice) [ see Warnings and Precautions ( 5.4 ) ]. Congestive Heart Failure Instruct patients to seek medical attention and consult their prescriber if they develop signs or symptoms of heart failure [ see Warnings and Precautions ( 5.5 ) ]. Hematologic Reactions Instruct patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on ZYMFENTRA [ see Warnings and Precautions ( 5.6 ) ]. Hypersensitivity Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [ see Warnings and Precautions ( 5.7 ) ]. Neurologic Reactions Advise patients to seek medical attention if they develop signs or symptoms of neurologic reactions [ see Warnings and Precautions ( 5.8 ) ]. Live Vaccines/Therapeutic Infectious Agents Instruct ZYMFENTRA-treated patients to avoid receiving live vaccines or therapeutic infectious agents [ see Warnings and Precautions ( 5.12 ) ] Administration Instruct patients to follow sharp disposal recommendations, as described in the Instructions for Use.
Label text from the FDA structured product label by CELLTRION USA Inc. (revised Aug 18, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Infliximab-dyyb in 1 product
Zymfentra NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 72606-025 | Kit | CELLTRION USA Inc. | BLA |
| 72606-047 | Infliximab-dyyb 120 mg/mL Injection | CELLTRION USA Inc. | BLA |
Frequently asked questions
What is Zymfentra used for?
1 INDICATIONS AND USAGE 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. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in…
What are the side effects of Zymfentra?
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious infections [ see Warnings and Precautions ( 5.1 ) ] Malignancies [ see Warnings and Precautions ( 5.2 ) ] Hepatitis B virus reactivation [ see Warnings and Precautions ( 5.3 ) ] Hepatotoxicity [ see Warning and Precautions ( 5.4 ) ] Congestive heart failure [ see Warnings and Precautions ( 5.5… See the full label for the complete list.
Who makes Zymfentra?
Zymfentra is listed by 1 labeler in the FDA NDC directory, including CELLTRION USA Inc..