For more info and updates
Connect with us
About ulcerative colitis
What is ulcerative colitis?
Ulcerative colitis is a form of inflammatory bowel disease (IBD). It is a long-term condition involving inflammation of the large intestine or colon. In patients with ulcerative colitis, small sores or ulcers form along the lining of the colon. These ulcers cause stomach pain and the need to empty your bowels frequently.
What are the symptoms of ulcerative colitis?
The symptoms of ulcerative colitis vary from person to person. About half of all patients with ulcerative colitis experience mild symptoms. Common symptoms include:
- Loose and urgent bowel movements
- Bloody stool
- Belly pain and cramps
- Persistent diarrhea with belly pain and blood in the stool
How is ulcerative colitis diagnosed?
To diagnose ulcerative colitis, your healthcare provider will usually review your medical history and order tests to look for signs of ulcerative colitis and rule out other possible causes of your symptoms. Tests may include laboratory tests, X-rays of your upper and lower digestive tract, and additional tests designed to look inside your colon and rectum.
Is ulcerative colitis hereditary?
Studies have shown that up to 30% of people with ulcerative colitis have a first-degree relative (such as a parent, child, or sibling) who also has the disease. Even though there is a genetic component to inflammatory bowel disease (IBD), there is no way to predict who may get ulcerative colitis based on family history.
Who is affected by ulcerative colitis?
Ulcerative colitis can affect people of any age, race, or ethnic group. Most people tend to be diagnosed in their mid-30s.
What are flares?
Because ulcerative colitis is a long-term illness, patients will likely experience times when symptoms are active, followed by periods of remission. Active symptoms are known as flares or flare-ups. Remission is when your symptoms get much better or even go away completely.
About ZYMFENTRA
What is ZYMFENTRA?
ZYMFENTRA is a self-injected form of infliximab. Other FDA-approved forms of infliximab include Remicade®, Inflectra®, Renflexis®, and Avsola®.* This is the first time that infliximab is available in the United States as a prefilled pen or syringe, potentially giving patients more control over how and where they receive their treatment.
ZYMFENTRA is a prescription medicine for adults given as an injection under the skin (subcutaneously) for the maintenance treatment of:
- moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous (IV) infusion
- moderately to severely active Crohn’s disease following treatment with an infliximab product given by intravenous (IV) infusion
FDA, Food and Drug Administration.
*Remicade® (infliximab), Inflectra® (infliximab-dyyb), Renflexis® (infliximab-abda), and Avsola® (infliximab-axxq) are registered trademarks of their respective companies.
How is ZYMFENTRA provided?
ZYMFENTRA is provided as a single-dose prefilled pen or a single-dose prefilled syringe with needle guard. Your healthcare provider will prescribe the type that is best for you.
How does ZYMFENTRA work?
ZYMFENTRA targets and blocks a protein in the body called tumor necrosis factor (TNF). In patients with inflammatory bowel disease (IBD) and other diseases, TNF can be overproduced, causing the immune system to attack normal, healthy parts of the body. By blocking TNF, ZYMFENTRA lowers inflammation in the gut to help you feel better. The connection between the TNF-blocking activities of ZYMFENTRA and how ZYMFENTRA works in the body to treat patients is not fully understood.
What should I know about injecting ZYMFENTRA?
ZYMFENTRA is administered as an injection under your skin (subcutaneously). Your healthcare provider will instruct you on how often to take your dose based on your condition. You or your caregiver will be shown how to prepare and inject ZYMFENTRA. Do not inject ZYMFENTRA without first receiving training from a healthcare provider and reviewing the Instructions for Use.
ZYMFENTRA is injected under the skin, in 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.
What happens if I miss a dose of ZYMFENTRA?
If you are not able to inject ZYMFENTRA at your regular scheduled time or you miss a dose of ZYMFENTRA, inject the dose as soon as possible. Then, inject your next dose every 2 weeks thereafter. If you are not sure when to inject ZYMFENTRA, call your healthcare provider.
I already receive maintenance therapy with infliximab at an infusion center. Can I shift to ZYMFENTRA?
Patients who receive infliximab at an infusion center can usually be shifted to ZYMFENTRA. Talk with your healthcare provider to see if you’re a good candidate for ZYMFENTRA.
What are the benefits of ZYMFENTRA?
ZYMFENTRA provides an innovative and convenient dosing option, giving patients more control over how and where they receive their treatment. In addition to offering flexibility and convenience, ZYMFENTRA can help minimize travel to infusion centers or doctor’s offices to receive treatment.
What are the most common side effects of ZYMFENTRA?
The most common side effects include COVID-19, joint pain, respiratory infections, such as sinus infections and sore throat, diarrhea, injection site reactions, high blood pressure, headache, urinary tract infections, abdominal pain, dizziness, and abnormal liver enzymes.
These are not all of the possible side effects of ZYMFENTRA.
You should also review "What is the most important information I should know about ZYMFENTRA?" in the Medication Guide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
You may also report side effects to Celltrion USA, Inc. at 1-800‑560‑9414.
FDA, Food and Drug Administration.
How should I store ZYMFENTRA?
Store ZYMFENTRA prefilled pens and prefilled syringes in a refrigerator at 36°F to 46°F (2°C to 8°C). If needed, you may store ZYMFENTRA at room temperature at 68°F to 77°F (20°C to 25°C) for up to 14 days. Once ZYMFENTRA has been stored at room temperature, it should not be placed back into the refrigerator. Throw away (discard) ZYMFENTRA if not used within the 14 days. Do not freeze ZYMFENTRA. Be sure not to shake ZYMFENTRA. Keep ZYMFENTRA in the original carton to protect it from light until ready to use.
Keep ZYMFENTRA and all medicines out of the reach of children.
Celltrion CARES® Co-Pay Program
Got a prescription? Check your eligibility for the Celltrion CARES Co-Pay Program.
If eligible, you may pay as little as $0* out of pocket for each dose.
*Only for commercially insured patients. Eligibility criteria and program maximums apply. Please see full Terms and Conditions.
Celltrion CONNECT® Patient Support Program
Help verify your insurance coverage for ZYMFENTRA, determine your plan-specific requirements, and understand your available benefits.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZYMFENTRA?
ZYMFENTRA may cause serious side effects, including risk of infection and cancer.
- Risk of infection: ZYMFENTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving ZYMFENTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.
- Your doctor should test you for TB before starting ZYMFENTRA, and should monitor you closely for signs and symptoms of TB during treatment.
- If you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. ZYMFENTRA can make you more likely to get infections or make any infection that you have worse.
- Risk of cancer: There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF) blocker medicines, such as ZYMFENTRA.
- For people receiving TNF blocker medicines, the chances of getting lymphoma or other cancers may increase.
- Some people receiving TNF blockers developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine.
- People who have been treated for Crohn's disease or ulcerative colitis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
- Some people treated with infliximab products have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment, tell your doctor.
- Patients with chronic obstructive pulmonary disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with ZYMFENTRA.
- Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.
Do not take ZYMFENTRA if you:
- Have had an allergic reaction to ZYMFENTRA, other infliximab products, any murine proteins, or any of the ingredients in ZYMFENTRA.
Before you receive ZYMFENTRA, tell your doctor about all of your medical conditions, including if you:
- Have an infection.
- Have other liver problems including liver failure.
- Have heart failure or other heart conditions.
- Have or have had any type of cancer.
- Have COPD, a specific type of lung disease.
- Have or have had a condition that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome, or if you experience any numbness or tingling, or if you have had a seizure.
- Have recently received or are scheduled to receive a vaccine. Adults should have all their vaccines brought up to date before starting treatment with ZYMFENTRA.
- Are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
What should I avoid while taking ZYMFENTRA?
- Do not take ZYMFENTRA together with other medicines called biologics that are used to treat the same conditions as ZYMFENTRA.
What are the possible side effects of ZYMFENTRA?
ZYMFENTRA can cause serious side effects, including:
- Serious infections:
- Tell your doctor right away if you have any signs of an infection, including a fever, tiredness (fatigue), a cough, flu-like symptoms, or warm, red, or painful skin.
- Your doctor will examine you for TB and perform a test to see if you have TB.
- If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with ZYMFENTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment, while you are being treated, and for several months after you finish treatment. Tell your doctor if you have symptoms such as feeling unwell, poor appetite, tiredness (fatigue), fever, skin rash, or joint pain.
- Liver injury:
- Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have jaundice (skin and eyes turning yellow), dark, brown-colored urine, pain on the right side of your stomach area (right-sided abdominal pain), fever, or extreme tiredness (severe fatigue).
- Heart failure:
- If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving ZYMFENTRA. Your congestive heart failure may get worse while you are receiving ZYMFENTRA. Be sure to tell your doctor of any new or worse symptoms including shortness of breath, swelling of ankles or feet, or sudden weight gain
- Treatment may need to be stopped if you get new or worse congestive heart failure.
- Blood problems:
- In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you have a fever that does not go away, bruise or bleed very easily, or look very pale.
- Allergic reactions:
- Signs of an allergic reaction can include hives (red, raised, itchy patches of skin), difficulty breathing, chest pain, high or low blood pressure, fever, and chills.
- Tell your doctor right away if you have any of these signs of delayed allergic reaction such as fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
- Nervous system disorders:
- Tell your doctor if you have changes in your vision, numbness or tingling in any part of your body, seizures, or weakness in your arms or legs.
- Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion; trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
- Lupus-like syndrome:
- Your doctor may decide to stop treatment if you develop symptoms such as chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on the cheeks or arms that gets worse in the sun.
The most common side effects include COVID-19, joint pain, respiratory infections such as sinus infections and sore throat, diarrhea, injection site reactions, high blood pressure, headache, urinary tract infections, abdominal pain, dizziness, and abnormal liver enzymes.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see the Medication Guide and talk with your healthcare provider.
INDICATIONS
ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately to severely active ulcerative colitis or moderately to severely active Crohn’s disease following treatment with an infliximab product given by intravenous infusion (IV).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZYMFENTRA?
ZYMFENTRA may cause serious side effects, including risk of infection and cancer.
- Risk of infection: ZYMFENTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving ZYMFENTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.
- Your doctor should test you for TB before starting ZYMFENTRA, and should monitor you closely for signs and symptoms of TB during treatment.
- If you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. ZYMFENTRA can make you more likely to get infections or make any infection that you have worse.
- Risk of cancer: There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF) blocker medicines, such as ZYMFENTRA.
- For people receiving TNF blocker medicines, the chances of getting lymphoma or other cancers may increase.
- Some people receiving TNF blockers developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine.
- People who have been treated for Crohn's disease or ulcerative colitis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
- Some people treated with infliximab products have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment, tell your doctor.
- Patients with chronic obstructive pulmonary disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with ZYMFENTRA.
- Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.
Do not take ZYMFENTRA if you:
- Have had an allergic reaction to ZYMFENTRA, other infliximab products, any murine proteins, or any of the ingredients in ZYMFENTRA.
Before you receive ZYMFENTRA, tell your doctor about all of your medical conditions, including if you:
- Have an infection.
- Have other liver problems including liver failure.
- Have heart failure or other heart conditions.
- Have or have had any type of cancer.
- Have COPD, a specific type of lung disease.
- Have or have had a condition that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome, or if you experience any numbness or tingling, or if you have had a seizure.
- Have recently received or are scheduled to receive a vaccine. Adults should have all their vaccines brought up to date before starting treatment with ZYMFENTRA.
- Are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
What should I avoid while taking ZYMFENTRA?
- Do not take ZYMFENTRA together with other medicines called biologics that are used to treat the same conditions as ZYMFENTRA.
What are the possible side effects of ZYMFENTRA?
ZYMFENTRA can cause serious side effects, including:
- Serious infections:
- Tell your doctor right away if you have any signs of an infection, including a fever, tiredness (fatigue), a cough, flu-like symptoms, or warm, red, or painful skin.
- Your doctor will examine you for TB and perform a test to see if you have TB.
- If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with ZYMFENTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment, while you are being treated, and for several months after you finish treatment. Tell your doctor if you have symptoms such as feeling unwell, poor appetite, tiredness (fatigue), fever, skin rash, or joint pain.
- Liver injury:
- Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have jaundice (skin and eyes turning yellow), dark, brown-colored urine, pain on the right side of your stomach area (right-sided abdominal pain), fever, or extreme tiredness (severe fatigue).
- Heart failure:
- If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving ZYMFENTRA. Your congestive heart failure may get worse while you are receiving ZYMFENTRA. Be sure to tell your doctor of any new or worse symptoms including shortness of breath, swelling of ankles or feet, or sudden weight gain
- Treatment may need to be stopped if you get new or worse congestive heart failure.
- Blood problems:
- In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you have a fever that does not go away, bruise or bleed very easily, or look very pale.
- Allergic reactions:
- Signs of an allergic reaction can include hives (red, raised, itchy patches of skin), difficulty breathing, chest pain, high or low blood pressure, fever, and chills.
- Tell your doctor right away if you have any of these signs of delayed allergic reaction such as fever, rash, headache, sore throat, muscle or joint pain, swelling of the face and hands, or difficulty swallowing.
- Nervous system disorders:
- Tell your doctor if you have changes in your vision, numbness or tingling in any part of your body, seizures, or weakness in your arms or legs.
- Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion; trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness; loss of balance or coordination; or a sudden, severe headache.
- Lupus-like syndrome:
- Your doctor may decide to stop treatment if you develop symptoms such as chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on the cheeks or arms that gets worse in the sun.
The most common side effects include COVID-19, joint pain, respiratory infections such as sinus infections and sore throat, diarrhea, injection site reactions, high blood pressure, headache, urinary tract infections, abdominal pain, dizziness, and abnormal liver enzymes.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see the Medication Guide and talk with your healthcare provider.
INDICATIONS
ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately to severely active ulcerative colitis or moderately to severely active Crohn’s disease following treatment with an infliximab product given by intravenous infusion (IV).