Ixifi (infliximab-qbtx) is an FDA-approved biologic prescription medication made using living cells. It is used to treat certain inflammatory and autoimmune conditions like rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. 

The FDA first approved Ixifi on December 13, 2017. It was approved as a biosimilar to Remicade (infliximab), meaning it is highly similar to the reference product, with no clinically meaningful differences in safety, purity, or potency. Other infliximab biosimilars include Inflectra and Renflexis.

The active ingredient in Ixifi is infliximab. It works by blocking a protein called TNF-alpha, which causes inflammation in your body. Ixifi comes as a 100 mg powder in a single-dose vial that is mixed with liquid before it is given as an intravenous (IV) infusion.

In this article, we’ll cover Ixifi uses, dosage, side effects, precautions, cost, and more. 

What Is Ixifi Used For?

Ixifi is an FDA-approved medication to treat the following conditions [2][3]:

Crohn’s Disease: In adult patients with moderate to severe active Crohn’s disease, Ixifi can:

• Reduce the signs and symptoms of the disease
• Induce and maintain clinical remission when conventional treatments have not worked well
• Reduce the number of draining enterocutaneous and rectovaginal fistulas
• Help maintain fistula closure in adults with fistulizing Crohn’s disease

Pediatric Crohn’s Disease: Healthcare providers use Ixifi in children 6 years of age and older with moderate to severe active Crohn’s disease. It can reduce signs and symptoms of the disease and induce and maintain clinical remission.

Ulcerative Colitis: Ixifi is used in adults and children 6 years and older with moderate to severe active ulcerative colitis when conventional treatments have not worked well. Ixifi can reduce your symptoms, induce and maintain remission, promote mucosal healing, and help eliminate the need for corticosteroids in adults.

Rheumatoid Arthritis: If you have moderate to severe rheumatoid arthritis, you can use Ixifi in combination with methotrexate. It can help reduce the symptoms, slow the progression of structural joint damage, and improve physical function.

Ankylosing Spondylitis: Ixifi can reduce the symptoms in adults with ankylosing spondylitis.

Psoriatic Arthritis: Ixifi is used in adults with psoriatic arthritis. It can improve your symptoms, slow the progression of joint damage, and improve physical function.

Plaque Psoriasis: Ixifi is used in adults with chronic, severe plaque psoriasis who are candidates for treatment with systemic medications and when other systemic treatment options are medically less appropriate.

Please note that Ixifi does not cure these conditions. Instead, it blocks the activity of TNF-alpha (a protein that promotes inflammation) to control the inflammation responsible for many of the symptoms.

How Does Ixifi Work?

Your immune system normally protects the body from infections and other harmful substances. However, in autoimmune and inflammatory diseases, your immune activity can become excessive or persist for too long. TNF-alpha is an important protein that is involved in this process. It promotes inflammation and contributes to the symptoms and tissue damage associated with several inflammatory diseases.

Ixifi contains the active ingredient infliximab-qbtx. It is a monoclonal antibody that blocks TNF-alpha. By doing this, it reduces the inflammation that causes symptoms and tissue damage.

For example, in Crohn’s disease and ulcerative colitis, excessive inflammation in your digestive tract can cause abdominal pain, diarrhea, bleeding, and other symptoms. By blocking TNF-alpha, Ixifi reduces this inflammation and promotes clinical remission.

Ixifi Side Effects

Here are some of the common and serious side effects of Ixifi [3]:

Common Side Effects

• Respiratory infections, such as sinus infections and sore throats
• Headache
• Coughing
• Stomach pain
• Infusion-related reactions
• Viral infections

These side effects are usually mild, but tell your doctor if they persist or get worse.

Serious Side Effects and Warnings 

Serious side effects from Ixifi are rare, but they can occur. Here are some serious side effects and warnings associated with Ixifi: 

Serious Infections: Ixifi can increase the risk of serious infections because it suppresses your immune system. These infections can include tuberculosis (TB), bacterial infections, and invasive fungal infections. Ixifi should be discontinued if you develop a serious infection or sepsis. 

Cancer: Lymphoma and other malignancies, some fatal, have been reported in children and adults treated with TNF blockers, including infliximab products. Your doctor will consider the potential risks and benefits of treatment, particularly if you have risk factors for certain cancers. 

Heart Failure: Ixifi can cause heart failure or make existing heart conditions worse. Tell your doctor if you have symptoms of heart failure, such as shortness of breath, swelling of the ankles or feet, or sudden weight gain. 

Liver Problems: In rare cases, Ixifi can cause liver problems. Severe liver injury, including cases resulting in liver transplant or death, has been reported with infliximab products. Contact your doctor if you experience symptoms such as yellowing of the skin or eyes, dark urine, severe fatigue, fever, or pain on the right side of your abdomen. 

Severe Allergic and Infusion Reactions: Ixifi can cause serious allergic or infusion reactions during or shortly after the infusion. Symptoms may include difficulty breathing, hives, chest pain, swelling, dizziness, or a significant change in blood pressure.

Please note that this is not a complete list of all possible side effects. Contact your doctor immediately if you experience any severe or unusual symptoms while receiving Ixifi.

Dosing of Ixifi

Ixifi comes as a powder that is mixed with liquid before use. You’ll receive it through an intravenous (IV) infusion. The exact dose depends on the condition being treated, your body weight, and how you respond to treatment. Your healthcare provider will determine the right dosage for you. Below are the usual recommended dosages [2][3]:

Crohn’s Disease: For adult patients, the usual initial dose is 5 mg/kg given at week 0, week 2, and week 6. After these initial doses, 5 mg/kg is given every 8 weeks. For those who initially responded to the treatment but later have an inadequate response, the doctor may increase the dose to 10 mg/kg every 8 weeks.

For children aged 6 years and older, the dosage is 5 mg/kg given at week 0, week 2, and week 6, followed by 5 mg/kg every 8 weeks.

Ulcerative Colitis: For adults and children aged 6 years and older, the recommended dose is 5 mg/kg at week 0, week 2, and week 6, followed by 5 mg/kg every 8 weeks.

Rheumatoid Arthritis: Ixifi is used in adult patients in combination with methotrexate. The recommended dosage is 3 mg/kg given at week 0, week 2, and week 6, followed by 3 mg/kg every 8 weeks. Some patients may benefit from increasing the dose to up to 10 mg/kg every 8 weeks or receiving treatment as frequently as every 4 weeks, depending on their response.

Ankylosing Spondylitis: The recommended adult dose is 5 mg/kg given at week 0, week 2, and week 6, followed by 5 mg/kg given every 6 weeks.

Psoriatic Arthritis and Plaque Psoriasis: The recommended adult dose is 5 mg/kg given at week 0, week 2, and week 6, followed by 5 mg/kg given every 8 weeks.

Before Starting Ixifi

Before you start Ixifi, tell your healthcare provider your complete medical history, including whether you [3]:

• Have an active infection or a history of infections that keep coming back
• Have tuberculosis or have been in close contact with someone who has TB
• Have hepatitis B or have previously had hepatitis B
• Have heart failure or other heart problems
• Have a history of cancer
• Have a blood disorder or a history of abnormal blood counts
• Are pregnant, planning to become pregnant, or breastfeeding
• Take methotrexate, corticosteroids, azathioprine, 6-mercaptopurine, or other medicines that suppress the immune system
• Take any medicines, vitamins, or herbal supplements
• Have previously had an allergic reaction to infliximab or another biologic medicine

You should avoid live vaccines while receiving Ixifi because there’s a chance it can make you sick. Children receiving treatment should have their vaccinations reviewed before starting therapy.

Ixifi Cost

Ixifi is an expensive biologic medication. The total cost can vary depending on your condition, body weight, number of vials needed, the treatment schedule, insurance coverage, and where you receive treatment.

As one example, the listed price in Ontario, Canada, is about CAD $493 per 100-mg vial [4]. Prices in the U.S. and other locations may differ. For Crohn’s disease and ulcerative colitis, the recommended dose is 5 mg/kg at weeks 0, 2, and 6, followed by a 5 mg/kg dose every 8 weeks [3]. So, an 80-kg adult would need 400 mg per infusion, requiring four vials. This would cost approximately CAD $1,972 without insurance. 

Patients concerned about treatment expenses can explore Ixifi copay assistance programs to help reduce out-of-pocket costs.