ZYMFENTRA
infliximab-dyyb · KIT · CELLTRION USA Inc.
ZYMFENTRA is a kit containing infliximab-dyyb. Manufactured by CELLTRION USA Inc..
Key Facts
- Brand Name
- ZYMFENTRA
- Generic Name
- infliximab-dyyb
- NDC Code (Product)
72606-025- Manufacturer
- CELLTRION USA Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA761358
- Marketing Start
- 03/01/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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 onl…
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 )
Drug Interactions
7 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. S…
Adverse Reactions
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, con…
Frequently Asked Questions
What is ZYMFENTRA used for?
ZYMFENTRA contains infliximab-dyyb. It is a kit taken as directed. Consult your doctor for specific uses.
Is ZYMFENTRA a controlled substance?
ZYMFENTRA is not classified as a controlled substance by the DEA.
What is the generic name for ZYMFENTRA?
The generic name for ZYMFENTRA is infliximab-dyyb. There are 1 other brand versions of infliximab-dyyb.
What is the NDC code for ZYMFENTRA ?
The NDC (National Drug Code) for ZYMFENTRA is 72606-025, listed by CELLTRION USA Inc..