Ixifi®—Biosimilar for Remicade (infliximab)
Ixifi (infliximab-qbtx) is an engineered biologic medication that is “biosimilar” to Remicade (infliximab). It was recently approved for use in patients with moderately to severely active rheumatoid arthritis, to be used in combination with methotrexate. Biosimilar medications are approved based on the similarity of their action to approved medications.1 At this time, Ixifi is not commercially available in the US.
In clinical studies, Ixifi reduced signs and symptoms of RA, including slowing structural damage and improving physical functioning.2
Ixifi is not available in generic forms.
What are the ingredients in Ixifi?
The active ingredient in Ixifi is infliximab-qbtx.3
How does Ixifi work?
Ixifi is one of several monoclonal antibodies used to treat RA. Our bodies naturally produce antibodies, which are immune factors that act against bacteria, viruses, and other foreign organisms that invade and pose a threat to our health. Drug makers have engineered a variety of antibodies to target the mechanisms that cause certain diseases, including RA.
Like infliximab, Ixifi blocks the action of tumor necrosis factor-α (TNF-α). TNF-α is an important immune system signaling factor (called a cytokine) that plays a key role in swelling and inflammation. It is found in higher levels in the synovial fluid in the joints of patients with RA, and it is connected to inflammation as well as bone and cartilage damage. Blocking TNF-α helps tamp down the damage caused by the dysfunction of the immune system that is characteristic of RA. In addition, in rheumatoid arthritis, treatment with infliximab products blocks inflammatory cells from getting into already-swollen areas of the joints.2
What are the possible side effects of Ixifi?
Common side effects with Ixifi include2:
- Colds, sinusitis, and upper respiratory infections
- Infusion-related reactions, including:
- flu-like symptoms
- shortness of breath
- low blood pressure
- fever and chills
- stomach symptoms
- skin rash
- Stomach pain
In some patients, Ixifi can cause more harmful side effects. Patients who take Ixifi are at increased risk for serious infections, including tuberculosis, invasive fungal infections, viral infections, bacterial infections, and other opportunistic infections (infection caused by a microorganism that does not normally cause infection in humans, typically due to an abnormally functioning immune system).2
Children and adolescents as well as adults taking TNF-α blockers like infliximab and Ixifi are also at slightly higher risk for lymphoma and other cancers. Other rare but serious side effects include Hepatitis B reactivation, nerve diseases like multiple sclerosis, certain blood disorders, heart failure, liver problems, and lupus-type symptoms.2
This is not an exhaustive list of all potential side effects of Ixifi. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects, contact your doctor or healthcare provider immediately.
Things to note about Ixifi
Before taking Ixifi, tell your doctor if you2:
- Have a current infection or are prone to recurring infections, including open cuts
- Have HIV, diabetes, or a weakened immune system
- Have tested positive for TB or have been in close contact with someone who has TB
- Live in areas of the US known for fungal infections, including the Ohio and Mississippi Valley and the southwest
- Have or had Hepatitis B
- Have any nervous system problems like multiple sclerosis or Guillain-Barré syndrome
- Have or had congestive heart failure
- Have COPD, or chronic obstructive pulmonary disease
- Are scheduled to have surgery
- Are scheduled to receive a vaccine
- Are pregnant or plan to become pregnant or are breastfeeding
With Ixifi, there is an increased risk for serious infection. This is because Ixifi can decrease the ability of the immune system to fight infections. If an infection develops while you are taking this medication, or if you have a severe allergic reaction, contact your doctor immediately.2
Patients taking this medication should not receive live vaccines. Patients with heart disease should not take Ixifi, because it increases your risk of heart failure. Tell your doctor about any medications or supplements you are taking while on Ixifi, because it doesn’t mix well with certain medicines, especially other biologics approved to treat RA. It is important for doctors to test you for TB before you take Ixifi and to monitor for heart problems, infection, and nerve damage while you are on the medication.2
Ixifi is given through a vein in your arm via intravenous infusion. It must be administered by a healthcare provider at a medical office. Infusions take about two hours. If you have symptoms from the infusion, the treatment might be stopped or modified. Your doctor might give you some medicines before or during the treatment to help prevent side effects.2
The recommended dose of Ixifi is 3 mg/kg, given at 0, 2, and 6 weeks to begin. If the medication is working after 6 weeks, you can continue with a maintenance dose of 3 mg/kg every 8 weeks. If it is not working, your doctor might increase the dose to as much as 10mg/kg or repeat the treatment every 4 weeks. The disadvantage is that the risk of serious infection increases at higher doses. This medication is meant to be given with methotrexate.2
- FDA approves new Pfizer Biosimilar. Pfizer, Inc. New York, New York. Published December 13, 2017. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_new_pfizer_biosimilar. Accessed June 15, 2018.
- Prescribing Information. Pfizer, Inc. New York, New York. Revised December 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf Accessed June 15, 2018.
- Medication Guide. Pfizer, Inc. New York, New York. Revised December 2017.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761072s000lbl.pdf Accessed June 15, 2018.