Zymfentra

Pronunciation: Zim-fen-trah
Generic name: infliximab-dyyb
Dosage form: injection for subcutaneous use
Drug class: TNF alfa inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 25, 2023.

What is Zymfentra?

Zymfentra (infliximab-dyyb) is a tumor necrosis factor (TNF) blocker that may be used to treat moderately to severely active Crohn’s disease or ulcerative colitis following induction therapy with an IV infliximab product (such as Inflectra). It is a subcutaneous (SC) injection that people can self-administer at home.

Zymfentra is a reformulation that allows infliximab-dyyb to be given subcutaneously and is manufactured by Celltrion which also makes Inflectra. The FDA-approved biosimilars of infliximab available on the U.S. market are:

• infliximab-axxq (Avsola) – given by IV infusion
• infliximab-dyyb (Inflectra [IV infusion]; Zymfentra [SC injection])
• infliximab-abda (Renflexis) – given by IV infusion.

Zymfentra is the first FDA-approved subcutaneous formulation of infliximab and was approved on October 23, 2023.

How does Zymfentra work?

Zymfentra works by binding specifically to a protein called TNF-α (tumor necrosis factor-alpha), which is released by white blood cells as part of our body’s immune response to infection or invasion by foreign substances. Overproduction of TNF-α can cause inflammation, which can damage tissues, bones, and cartilage, and also cell death. When infliximab binds to TNF-α, it blocks its effects, and this reduces inflammation. Increased levels of TNF-alfa have been found in conditions such as inflammatory bowel disease, rheumatoid arthritis, psoriasis, and ankylosing spondylitis.

Zymfentra (infliximab-dyyb) is also called a monoclonal antibody because the definition of monoclonal antibodies is that they bind specifically to a protein – in this case, infliximab-dyyb binds specifically to TNF-α. It belongs to the class of medicines known as TNF alfa inhibitors or TNF blockers.

Warnings

Serious hypersensitivity or infusion reactions including anaphylaxis have occurred with infliximab products. People with previous hypersensitivity reactions to infliximab, murine proteins, or any of the inactive ingredients in Zymfentra should not use this product.

Zymfentra and other infliximab products affect your immune system and can reduce its ability to fight infections. Serious infections have happened in patients receiving infliximab, such as tuberculosis (TB) and infections caused by viruses, fungi, or bacteria. Some patients have died from these infections. Before you start using infliximab, your doctor may perform tests to make sure you do not have an infection, and prescribe antimicrobial treatment if necessary.

Infliximab may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma (called hepatosplenic T-cell lymphoma) that can be fatal.

Serious liver toxicity has been reported with infliximab products, such as Zymfentra, some cases required liver transplantation or were fatal. Tell your doctor if you notice any abdominal pain or yellowing of your skin or eyes.

Zymfentra may also increase your risk of developing congestive heart failure and cytopenia (low levels of red blood cells [anemia], white blood cells [leukopenia], or platelets [thrombocytopenia]).

You should be up to date with all your vaccinations before starting Zymfentra. Live vaccinations should not be given to people prescribed infliximab. A 6-month waiting period following birth is recommended for infants exposed to infliximab products while in the womb, before the administration of live vaccines.

Other warnings include a risk of additive immunosuppressant effects or an increase in the risk of infection occurring from the prior or concurrent use of biological products; an exacerbation of new onset of neurological reactions such as CNS demyelinating disorders; and a risk of the development of autoantibodies and lupus-like syndrome.

Before taking this medicine

You should not receive this product if you have had an allergic reaction to infliximab products, or any of the other ingredients in Zymfentra.

Before starting Zymfentra, tell your doctor if you:

• are being treated for an infection, have TB or hepatitis B, or have been in close contact with someone with TB or hepatitis B
• have signs of an infection, such as a fever, cough, flu-like symptoms, or get a lot of infections or have infections that keep coming back
• have any open cuts or sores on your body
• have diabetes or an immune system problem. People with these conditions have a higher chance of infections
• have ever had cancer
• have COPD, heart failure, or other heart problems
• have a nerve-muscle disorder, such as multiple sclerosis, Guillain-Barré syndrome, seizures, or experienced numbness or tingling anywhere in your body
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk of getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive infliximab. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor
• use or have used other biologics such as anakinra, abatacept, or other biologics used to treat the same condition.
• have recently received or are scheduled to receive any vaccines. Make sure you have received all your routine childhood vaccinations before starting infliximab. You should not receive any live vaccines while being treated including weak vaccines such as BCG for bladder cancer
• are pregnant, plan to become pregnant, or breastfeeding.

Pregnancy

There is not enough data to determine if there is an association between the use of Zymfentra during pregnancy and an increased 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

If you use Zymfentra while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to infliximab in the womb could affect your baby's vaccination schedule during the first 6 months of life.

Breastfeeding

There are no data on the presence of Zymfentra or its metabolites in either human or animal

milk, the effects on the breastfed infant, or the effects on milk production after subcutaneous

administration. Talk to your doctor about breastfeeding while receiving Zymfentra.

How is Zymfentra administered?

Administer Zymfentra exactly as your doctor tells you to. Do not attempt to self-administer it unless your healthcare provider has shown you how to do so.

• Zymfentra is available as a single-dose prefilled syringe or pen.
• It is injected under your skin (subcutaneously) 1 time every two weeks.
• It may be injected under the skin of your upper arms, stomach area (abdomen), or upper legs (thighs).
• Do not give an injection in an area of the skin that is tender, bruised, red, or hard.
• Use a different injection site each time you use Zymfentra.

Dosage

Zymfentra is used for maintenance treatment only, starting at Week 10 and thereafter.

• All patients must complete an IV induction regimen with an infliximab product before starting Zymfentra.
• The usual dose is 120mg for Crohn’s disease and Ulcerative colitis.
• Administer the first SC dose of Zymfentra in place of the next scheduled IV infusion and every 2 weeks thereafter.

What should I avoid while taking Zymfentra?

Do not take it with other medicines called biologics that are used to treat the same conditions as Zymfentra.

Do not receive a "live" vaccine while using infliximab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

If you need surgery, tell the surgeon ahead of time that you are using Zymfentra.

What happens if I miss a dose?

If you miss a dose of Zymfentra, inject the dose as soon as possible. Then, inject your next dose every two weeks thereafter.

What happens if I overdose?

If you inject more than prescribed, call your doctor right away.

What are the side effects of Zymfentra?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficulty breathing; fever, chills, severe dizziness; swelling of your face, lips, tongue, or throat.

Serious infections, such as TB and infections caused by viruses, fungi, or bacteria, have occurred in some patients, especially those 65 years and older, while receiving infliximab products, such as Zymfentra. Some patients die from these infections.

The most common side effects reported in 3% or more of people receiving Zymfentra, depending on the condition being treated, include:

• COVID-19 and other infections
• Anemia and other abnormal laboratory tests
• Joint pain
• Injection site reactions
• Abdominal pain
• Headaches
• Diarrhea
• High blood pressure
• Urinary tract infections
• Neutropenia
• Dizziness.

Tell your doctor right away if you have any of the following signs of an infection such as:

• a fever
• feel very tired
• have a cough
• have flu-like symptoms
• warm, red, or painful skin.

Also, call your doctor if you have:

• skin changes, new growths on your skin
• easy bruising or bleeding
• a delayed allergic reaction (up to 12 days after receiving Zymfentra), symptoms may include a fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands
• liver problems--right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes, and not feeling well
• lupus-like syndrome--joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight)
• nerve problems--numbness or tingling, problems with vision, weakness in your arms or legs, or a seizure
• signs of heart failure--shortness of breath with swelling of your ankles or feet, rapid weight gain
• signs of a stroke--sudden numbness or weakness, trouble speaking or understanding what is said to you, problems with vision or balance, severe headache
• signs of lymphoma--fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin) or
• signs of tuberculosis--fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Zymfentra?

Some medications may affect how Zymfentra works or increase the risk of side effects. Tell your doctor about all your other medicines, especially:

• abatacept
• anakinra
• tocilizumab
• any "biologic" medications you take such as adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others; or
• any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

This list is not complete. Other drugs may affect infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ingredients

Active: Infliximab-dyyb 120mg

Inactive: acetic acid, polysorbate 80, sodium acetate, and sorbitol in water for injections. No preservatives are present.

Supplied as a:

• single-dose pre-filled syringe 120 mg/mL
• single-dose pre-filled syringe with needle shield 120 mg/mL
• single-dose pre-filled pen 120 mg/mL.

The needle shield is not made with natural rubber latex or any derivatives from natural rubber latex.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep it in its outer carton until the time of administration to protect it from light.

Manufacturer

Celltrion.

Zymfentra Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Zymfentra.

Remicade biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

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Further information

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