IXIFI is a prescription medicine that is approved for patients with:

  • Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
  • Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
  • Ankylosing Spondylitis
  • Psoriatic Arthritis
  • Plaque psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and or disabling.
  • Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

IXIFI blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body’s immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. IXIFI can block the damage caused by too much TNF-alpha.

Side Effects Of Ixifi

IXIFI may cause serious side effects, including:

Risk of infection

IXIFI is a medicine that affects your immune system. It can lower the ability of your immune system to fight infections.

Serious infections have happened in patients receiving IXIFI. 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 IXIFI.
  • Your doctor should monitor you closely for signs and symptoms of TB during treatment with IXIFI.

After starting IXIFI, 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. It 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 IXIFI.
  • For children and adults receiving TNF-blocker medicines, including IXIFI, the chances of getting lymphoma or other cancers may increase.
  • Some people receiving TNF-blockers, including IXIFI, 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 rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active diseases.
  • Some people treated with infliximab products, such as IXIFI, 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 with IXIFI, 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 IXIFI.
  • Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving IXIFI, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
  • 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.

Warnings & Precautions

You should not receive IXIFI if you have:

  • heart failure, unless your doctor has examined you and decided that you are able to receive IXIFI. Talk to your doctor about your heart failure.
  • had an allergic reaction to infliximab products or any of the other ingredients in IXIFI. See the end of this Medication Guide for a complete list of ingredients in IXIFI.

Before starting IXIFI, tell your doctor if you:

  • think you have an infection. You should not start receiving IXIFI if you have any kind of infection.
      • are being treated for an infection.
      • have signs of an infection, such as a fever, cough, flu-like symptoms.
      • have any open cuts or sores on your body.
      • get a lot of infections or have infections that keep coming back.
  • have diabetes or an immune system problem. People with these conditions have a higher chance of infections.
  • have TB, or have been in close contact with someone with TB.
  • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis).
  • These infections may develop or become more severe if you receive IXIFI. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
  • have or have had hepatitis B.
  • use the medicines KINERET (anakinra), ORENCIA (abatacept), ACTEMRA (tocilizumab), or other medicines called biologics used to treat the same conditions as IXIFI.

Dosage Of Ixifi

You will be given IXIFI through a needle placed in a vein (IV or intravenous infusion) in your arm.

  • Your doctor may decide to give you medicine before starting the IXIFI infusion to prevent or lessen side effects.
  • Only a healthcare professional should prepare the medicine and administer it to you.
  • IXIFI will be given to you over a period of about 2 hours.
  • If you have side effects from IXIFI, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
  • A healthcare professional will monitor you during the IXIFI infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving IXIFI to monitor you for side effects and to see how well you respond to the treatment.
  • Your doctor will determine the right dose of IXIFI for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.


Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use IXIFI for a condition for which it was not prescribed. Do not give IXIFI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about IXIFI that is written for health professionals.


All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.