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.

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).

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.