ZYMFENTRA

ZYMFENTRA is an FDA-registered drug product whose active ingredient is INFLIXIMAB-DYYB. It is labelled by CELLTRION USA Inc. taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 72606-025, application BLA761358, label effective 20260818. It is one of 2 FDA drug label records sharing the active ingredient INFLIXIMAB-DYYB. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing INFLIXIMAB-DYYB are most often described in connection with: moderately severely, following treatment, infliximab product, indicated adults, active ulcerative, administered intravenously, crohn disease, usage zymfentra. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

2 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.

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 )

6 ADVERSE REACTIONS 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 ) ]. Hepatotoxicity Three cases of drug induced liver injury were noted in ZYMFENTRA-treated subjects that led to study drug discontinuation [ see W arnings and Precautions ( 5.4 ) ]. In two subjects in UC Trial I, ALT and AST levels started rising 7 to 12 months after starting ZYMFENTRA, reaching peak values of 4 to 11x ULN for ALT, and 2 to 7x ULN for AST. Inboth subjects, total bilirubin levels remains below 2x ULN. In one subject in CD Trial I, ALT and AST started rising within a month after starting ZYMFENTRA, reaching peack values of 18x ULN for ALT and 14.9x ULN for AST. At approximately 5 months, total bilirubin level also increased to a peak value of 2.5x ULN. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of outside of the U.S with a non-U.S approved infliximab product administered subcutaneously. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and infestations: cellulitis, disseminated tuberculosis, lower respiratory tract infection, pneumonia, sepsis Neoplasms benign, malignant and unspecified: breast cancer, gastric cancer, lung cancer Nervous system disorders: multiple sclerosis General disorders and administration site conditions : fatigue, malaise The following additional adverse ractions have been identified during post-approval use of infliximab products administered intravenously. Neutropenia, agranuloxytosis (including infants exposed in utero to infliximab products), idiopathis thrombocytopenic purpura, thrombotic thrombocytopenic purpura. Interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and rapidly progessive disease). Pericardial effusion, systemic and cutaneous vasculitis. Erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, linear IgA bullous dermatosis (LABD), acute generalized exanthematous pustulosis (AGEP), new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar), lichenoid react. Preipheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy) transverse myelitis, and neuropathies (additional neurologic reactions have also been observed). Acute liver failure, jaundice, hepatitis, and cholestasis. Serious infections and vaccine breakthrough infection including bovine tuberculosis (disseminated BCG infection) following vaccination in an infant exposed in utero to infliximab products. Malignancies, including leukemia, melanoma, Merkel cell carcinoma, and cervical cancer. Anaphylactic reactions, including anaphylactic shock, laryngeal/pharyngeal edema and severe bronchospasm, and seizure. Transient visual loss has been reported in association with infliximab products during or within 2 hours of infusion. Cerebrovascular accidents, myocardial ischemia/infarction (some fatal), and arrhythmia occurring within 24 hours of initiation of infusion have also been reported.

FDA lists 2 drug label records with INFLIXIMAB-DYYB as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

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 …

Who makes ZYMFENTRA?
CELLTRION USA Inc. is the labeler of record for ZYMFENTRA. 2 FDA label records share the active ingredient INFLIXIMAB-DYYB, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ZYMFENTRA come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ZYMFENTRA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing INFLIXIMAB-DYYB?
Yes. 2 FDA drug label records list INFLIXIMAB-DYYB as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ZYMFENTRA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.