Zymfentra
Zymfentra (infliximab or infliximab-dyyb) is an injectable biologic medication for moderate-to-severe ulcerative colitis and Crohn's disease. It's a monoclonal antibody called a tumor necrosis factor (TNF) blocker. Zymfentra (infliximab) is a maintenance treatment that's injected under the skin once every 2 weeks at home, either by yourself or with the help of a caregiver. It's approved for adults who've already had 10 weeks of treatment with an intravenous (IV) infliximab product like Remicade (infliximab). Side effects of Zymfentra (infliximab) include reactions at the injection site. It can also raise your risk for infection.
What is Zymfentra (infliximab)?
What is Zymfentra (infliximab) used for?
- Maintenance treatment of moderate-to-severe ulcerative colitis (UC) after 10 weeks of infliximab treatment through the vein (IV).
- Maintenance treatment of moderate-to-severe Crohn's disease (CD) after 10 weeks of IV infliximab treatment.
How Zymfentra (infliximab) works
Zymfentra (infliximab) is a monoclonal antibody called a tumor necrosis factor blocker (TNF blocker). It blocks TNF-alpha, a protein that causes inflammation in the body and plays a role in ulcerative colitis and Crohn's disease. By blocking TNF-alpha, Zymfentra (infliximab) is thought to help lessen inflammation in the gut and ease symptoms of ulcerative colitis and Crohn's disease.
Drug facts
More on Zymfentra (infliximab) essentials
Side effects of Zymfentra (infliximab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
People with ulcerative colitis:
- COVID-19 symptoms (10%)
- Anemia (5%)
- Joint pain (4%)
- Reaction at the injection site (e.g., bruising, swelling, pain, redness; 3%)
- Elevated liver enzyme levels (3%)
- Belly pain (3%)
People with Crohn's disease:
- COVID-19 symptoms (10%)
- Headache (8%)
- Upper respiratory infections (7%)
- Reaction at the injection site (e.g., bruising, swelling, pain, redness; 5%)
- Diarrhea (5%)
- Higher creatine phosphokinase levels (4%)
- Joint pain (4%)
- Elevated liver enzyme levels (4%)
Less Common Side Effects
People with Crohn's disease:
- High blood pressure
- Urinary tract infection (UTI)
- Dizziness
- Low white blood cell count
Zymfentra (infliximab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, difficulty breathing, cough, weakness, cough, sweating, chills, stomach pain, diarrhea, burning feeling when you urinate, urinating more frequently
- Symptoms of possible cancer: fatigue, loss of appetite, unusual skin changes, swollen lymph nodes, cough that doesn't go away, unexplained weight gain or weight loss, unusual bleeding
- Liver problems: swelling of your stomach, yellowing of your skin or the whites of your eyes, confusion
- Heart failure: shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; can't exercise; tiredness; weakness; sudden weight gain
- Low blood cell counts: fever, pale skin, fast heart rate, lightheadedness, easy bleeding or bruising, blood in urine or stool
- Problems related to the nervous system: seizure, changes in vision, weakness, numbness, tingling, balance problems
- Lupus-like symptoms: chest discomfort or pain, short of breath, joint or muscle pain, rash on cheeks or arms
- Serious allergic reaction: hives, itching, swelling of face or tongue, difficulty breathing, low blood pressure
The following Zymfentra (infliximab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Cough
- Diarrhea
- Headache
- Pain, redness, or irritation at injection site
- Runny or stuffy nose
- Sore throat
- Stomach pain
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Pros and cons of Zymfentra (infliximab)
Pros
- Injected every 2 weeks
- Available as prefilled syringes and pens so you can inject the medication at home
- Can help people achieve remission
Cons
- Must be injected
- Can raise the risk for infections
- Not recommended to take with other biologics (e.g., Humira (adalimumab), Kineret (anakinra)) because of the risk for infections
Pharmacist tips for Zymfentra (infliximab)
- Read the instructions on how to take Zymfentra (infliximab). Don't give yourself or someone else injections until you understand how to prepare and inject the medication. Your healthcare team will show you how to do your first injection. Ask your care team if you have more questions.
- Store Zymfentra (infliximab) in the refrigerator in its original container. Be careful not to freeze the medication. If needed, you can keep Zymfentra (infliximab) at room temperature for up to 14 days. Once the medication is at room temperature, don't place it back in the refrigerator.
- When it's time for your dose, take Zymfentra (infliximab) out of the refrigerator. Let it naturally come to room temperature for 30 minutes before you inject it.
- Inject Zymfentra (infliximab) once every 2 weeks. Inject into the fat under the skin on the front of the thighs or belly (at least 2 inches away from the belly button). Someone else can also help you inject it under the skin of your outer upper arm. Choose a different spot that's at least about an inch away each time to prevent skin irritation. Don't inject into skin that's bruised, red, tender, or hard.
- After you inject Zymfentra (infliximab), throw away each used syringe or pen into a sharps disposal container. Don't reuse needles, syringes, or pens. It can put you at risk for getting or spreading infections. Also don't throw away sharps into the regular trash to prevent needle-stick injuries.
- Talk to your healthcare team if you get sick while you're taking Zymfentra (infliximab). Look out for symptoms of infection like fever, cough, chills, sore throat, runny or stuffy nose, and body aches. This medication can raise your risk of developing serious infections.
- Zymfentra (infliximab) can rarely cause lupus-like symptoms. Contact your healthcare team if you experience rash, joint pain, muscle aches, easy bruising or bleeding, or feel more tired than usual.
- Before you get any vaccinations, tell your care team and pharmacist that you're taking Zymfentra (infliximab). They can make sure the vaccine you want to get is safe for you. Avoid getting live vaccines, like the nasal spray flu vaccine, while you're taking this medication because it can raise your risk of infection from the vaccine.
Common questions about Zymfentra (infliximab)
Zymfentra (infliximab) is available as an injectable medication in a prefilled syringe or pen. You use the prefilled syringe or pen to inject the medication under the skin into the fatty tissue of the front of the thigh or belly (at least 2 inches away from the belly button). Someone else can also help inject the medication under the skin on the outer side of your upper arm. Pick a different spot for each injection to avoid irritating your skin. Read the instructions for use for more information on how to administer Zymfentra (infliximab). Ask your healthcare team if you have more questions.
Yes. Zymfentra (infliximab) is considered a biologic. It's made from living sources. More specifically, this medication is a type of monoclonal antibody that's made in a lab. It's designed to find and attach to TNF-alpha proteins in the body and block their activity. This is thought to help lessen inflammation.
No, Zymfentra (infliximab) isn't a steroid. Instead it's a monoclonal antibody called a TNF blocker. Steroids and TNF blockers both work to lessen inflammation in the body, but they block different inflammatory chemicals and proteins to do so. Your healthcare team might prescribe Zymfentra (infliximab) along with oral steroids to treat your symptoms.
Yes, the FDA approved Zymfentra (infliximab) in October 2023. It's the under-the-skin injectable version of infliximab that's approved for maintenance treatment of adults with moderate-to-severe ulcerative colitis or Crohn's disease. Zymfentra (infliximab) can be used once people have had 10 weeks of treatment with intravenous (IV) infliximab.
No. Zymfentra (infliximab) isn't a biosimilar to Remicade (infliximab). Zymfentra and Remicade have the same active ingredient (infliximab). But Zymfentra can't be considered a biosimilar of Remicade, even though they're very similar to each other. This is because the two medications are given in different ways. Remicade is given as an infusion through the vein at a medical office or infusion center. But Zymfentra is an injection under the skin that can be given at home. Speak with your prescriber to learn more about the similarities and differences between Zymfentra (infliximab) and Remicade (infliximab).
In one study, a little more than 60% of people with Crohn’s disease who took Zymfentra (infliximab) achieved remission (symptom free) after 1 year of treatment. In comparison, about 30% of people who took placebo (no active medication) achieved remission. Follow up with your prescriber about how well Zymfentra (infliximab) is working for you.
A study showed that a little more than 40% of people with ulcerative colitis who took Zymfentra (infliximab) achieved remission (symptom free) after 1 year of treatment. In comparison, 20% of people who took placebo (no active medication) achieved remission. Follow up with your prescriber about how well Zymfentra (infliximab) is working for you.
Speak with your prescriber about whether you can take Zymfentra (infliximab) while pregnant. It's not clear whether this medication is safe to take during pregnancy. Some studies showed that intravenous (IV) versions of infliximab during pregnancy might put a newborn baby at higher risk of an infection. Let your obstetrician-gynecologist (OB-GYN) know before delivery and your child's pediatrician know at your first appointment if you took Zymfentra (infliximab) while you were pregnant. They might decide to hold off on giving your baby certain vaccines (e.g., live vaccines) until at least 6 months after birth.
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Risks and warnings for Zymfentra (infliximab)
Zymfentra (infliximab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
- Risk factors: Older than 65 years of age | Active, chronic (long-term), or recurrent infection | History tuberculosis (TB) or hepatitis B | History of medical conditions that can affect the immune system, such as diabetes or human immunodeficiency virus (HIV) | Taking other medications that can lower the immune system | Living in or traveling to areas at high risk for infection
Zymfentra (infliximab) can lower your ability to fight infections. This can put you at risk for serious bacterial, viral, and fungal infections. Examples of serious infections that people who took TNF blockers like Zymfentra (infliximab) had include tuberculosis (TB), candidiasis, and Valley Fever. During treatment, it's also possible for TB or hepatitis B to come back in people who've previously had these infections.
Be sure your prescriber knows about your medical history and the medications you take. They can make sure Zymfentra (infliximab) is safe for you. Let them know if you have any chronic infections, infections that keep coming back, and medical conditions that weaken the immune system. You might need to get tested for certain infections before you start Zymfentra (infliximab). In addition, some medications can raise your risk for infection. Examples include other biologics for UC and for Crohn's disease and corticosteroids.
Please let your healthcare team know right away if you have signs or symptoms of an infection while you're taking Zymfentra (infliximab). Look out for fever, chills, night sweats, cough, sore throat, and weakness. You might need to stop taking Zymfentra (infliximab) and get your infection treated.
Possible risk of cancer
- Risk factors: History of cancer | Moderate-to-severe chronic obstructive pulmonary disease (COPD)
Some people who've taken medications containing infliximab or similar TNF blockers have developed cancer. Cancers have included lymphomas and skin cancer, among others. These reports of cancer happened in people who started treatment when they were 18 years or younger. In most cases, they were taking more than one medication that can weaken the immune system.
Let your healthcare team know if you have any history of cancer. It's recommended to avoid taking Zymfentra (infliximab) if you've ever had cancer to lower your risk. Speak with your prescriber if you have concerns about this risk with Zymfentra (infliximab).
If you take Zymfentra (infliximab), your healthcare team will follow up with you as you continue treatment to make sure this medication is safe for you. Tell your care team right away if you have any concerning or unusual symptoms. They can check for signs of cancer.
Liver problems
Rarely, people who take medications that contain infliximab, such as Zymfentra (infliximab), can have serious liver problems. You'll need to get blood tests done every 3 to 4 months during treatment so your healthcare team can check your liver health. You might need to stop taking Zymfentra (infliximab) if your lab results show signs of liver damage.
Talk with your care team right away if you have symptoms of liver damage, such as nausea, vomiting, low appetite, upper right stomach pain, yellowing of the skin or whites of the eyes, or dark urine.
Heart failure
- Risk factor: History of heart failure
Some people who've taken TNF blockers like infliximab medications have developed new or worsening heart failure. Speak with your healthcare team if you currently have heart failure. It's best to avoid taking Zymfentra (infliximab) if you have heart failure to be safe. But your prescriber will weigh the risks and benefits of treatment.
Get medical help if you have new or worsening symptoms of heart failure while you're taking Zymfentra (infliximab). Watch out for shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; tiredness; and sudden weight gain.
Low blood cell counts
- Risk factor: History of blood problems
Although rare, some people had low blood cell counts while they took infliximab medications like Zymfentra (infliximab). This can lower your body's ability to fight infections and put you at risk for bleeding. Call your healthcare team right away if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding that's difficult to stop while you're taking Zymfentra (infliximab). These can be symptoms of having a low blood cell count.
Serious allergic reaction
Serious, life-threatening allergic reactions, including anaphylaxis, are possible with Zymfentra (infliximab). Watch for signs and symptoms of an allergic reaction, like rash, itching, skin redness, trouble breathing, and swelling of the face. Stop taking Zymfentra (infliximab) and get medical help right away if an allergic reaction happens.
Effects on the nervous system
- Risk factor: Currently have or recently developed a condition that affects the nervous system
Although rare, some people who've taken TNF blockers like Zymfentra (infliximab) have developed conditions that affect the nervous system. Examples include seizure, multiple sclerosis (MS), and Guillain-Barré syndrome.
Let your healthcare team know if you currently have any nerve problems. It's recommended to avoid taking Zymfentra (infliximab) if you currently have or develop nerve problems. Contact your care team right away if you have a seizure or notice numbness or tingling, weakness in your arms or legs, vision problems, dizziness, or balance problems.
Interaction with vaccines
It’s possible that Zymfentra (infliximab) can interact with any vaccine you get, though we don’t know the exact effect the medication has on vaccines. Zymfentra (infliximab) can affect how well the immune system works. And some medications that affect the immune system can make vaccines work less well. These medications can also raise the risk of getting sick after receiving live vaccines.
It's recommended that you're up to date with your vaccinations before you start taking Zymfentra (infliximab). Talk with your healthcare team about your vaccine history so they can check which vaccinations you need. Avoid getting any live vaccines, such as MMR (measles, mumps, and rubella vaccine) while you're taking Zymfentra (infliximab).
Zymfentra (infliximab) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 2 syringes of 120mg/ml | 2 cartons | $4,182.77 | $2,091.39 |
| 1 pen of 120mg/ml | 2 cartons | $6,177.43 | $3,088.72 |
| 2 pens of 120mg/ml | 2 cartons | $6,177.43 | $3,088.72 |
Typical dosage for Zymfentra (infliximab)
You can switch to Zymfentra (infliximab), the injectable version of infliximab, starting after week 10 of infliximab treatment that's infused through the vein (e.g., Remicade).
The typical dose of Zymfentra (infliximab) is 120 mg injected under the skin every 2 weeks.
How much does Zymfentra (infliximab) cost?
$4,182.77
Zymfentra (infliximab) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Zymfentra (infliximab) will not be safe for you to take.
- History of allergic reaction to any infliximab medication
- History of allergic reaction to mouse proteins (found in the Zymfentra (infliximab) monoclonal antibody)
What are alternatives to Zymfentra (infliximab)?
