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Inflectra® (infliximab-dyyb)

Inflectra is a biosimilar to Remicade® (infliximab) that is used to treat ankylosing spondylitis (AS) in people who have radiographic axial spondylitis (evidence of spinal joint damage visible on imaging) and that has not been adequately managed with NSAIDs (non-steroidal anti-inflammatory drugs). Inflectra is also approved to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis.

What is a biosimilar?

Biosimilars are a type of biologic therapy that are highly similar to an already approved biological product. To receive FDA approval, biosimilars must be like their reference product in several key characteristics, including purity, molecular structure, and bioactivity (how it acts in the body). Like biologics, biosimilars have bioengineered proteins that mimic certain functions in human genes or cells, and they are made from living organisms. The sources used to create biological products may be human, animal, bacteria, or yeast.2

What is the ingredient in Inflectra?

The active ingredient in Inflectra is infliximab-dyyb, a tumor necrosis factor-alpha (TNF-alpha) inhibitor.1

How does Inflectra work?

In people with AS, chronic inflammation occurs at the joints, primarily the joints in the spine but AS may also affect other joints in the body. AS can also cause other complications in the body, including complications involving the heart or the lungs.3,4

One of the proteins in the body that is involved in the inflammatory response is TNF. In people with AS, there is an excess or abnormal inflammatory response and elevated levels of TNF. As a TNF-alpha inhibitor, Inflectra binds to TNF-alpha blocking its action. Blocking TNF can help reduce the inflammation and help relieve the symptoms of AS.1

What are the possible side effects of Inflectra?

Inflectra can cause side effects, and some of these possible side effects can be serious. Because TNF is involved in the normal immune response of inflammation, taking a TNF blocker like Inflectra can make it harder to fight certain infections. Some people have experienced serious infections with TNF blockers including Inflectra, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and opportunistic infections. Some of these serious infections may lead to hospitalizations or death.1

Inflectra may increase the risk of developing lymphoma or other types of cancer. This risk may be increased in children and young adults.1,4

The most common side effects experienced by patients taking Inflectra include infections (such as upper respiratory infections and sinusitis), infusion-related reactions (such as rash or coughing), headache, and abdominal pain.1,4

This is not an exhaustive list of all potential side effects of Inflectra. For more information, patients should talk to their doctor about what to expect. Any new or worsening side effects should be reported to a doctor or healthcare professional.

Things to know about Inflectra

Before starting treatment with Inflectra, patients should talk to their doctors about all their medical conditions, especially if they:1

  • Have any signs of infection, including fever, cough, or open cuts or sores
  • Have frequent infections, diabetes, or an immune system problem
  • Have TB or have been around someone with TB
  • Lived in a region where certain fungal infections are common
  • Have had any type of cancer
  • Have heart failure or any heart condition
  • Have or have previously had a hepatitis B infection
  • Have a nervous system disorder, like multiple sclerosis or Guillain-Barré syndrome
  • Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed

Before beginning treatment with Inflectra, patients should talk to their doctors about all medications (over-the-counter and prescription), vitamins, and supplements they are taking, especially any other biologic medications. Some medications or supplements may increase the risk of side effects if taken in combination with Inflectra.1

Patients should be tested for TB before beginning treatment with Inflectra.1

If an infection occurs while taking Inflectra, patients should contact their doctor. If the infection becomes serious, treatment with Inflectra may be stopped.1

Patients taking this medication should not receive live vaccines.1

During treatment with Inflectra, patients should be monitored for any possible heart problems, nervous system disorders, infections, cancer, and liver functioning.1

Dosing information

Inflectra is given by intravenous (IV) infusion over a period of two hours or more. For AS, it is given at week 0 (the first week of receiving Inflectra), week 2 and week 6, and then every 6 weeks thereafter.1

Patients should talk to their doctor about any questions on their dosing regimen.

Written by: Emily Downward | Last reviewed: February 2019
  1. Inflectra prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf. Accessed 1/9/19.
  2. What is a biosimilar? Food and Drug Administration. Available at https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM585738.pdf. Accessed 1/9/19.
  3. Ankylosing spondylitis. Mayo Clinic. Available at https://www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/symptoms-causes/syc-20354808. Accessed 1/8/19.
  4. Ankylosing spondylitis. Columbia University Department of Neurological Surgery. Available at https://www.columbiaspine.org/condition/ankylosing-spondylitis-2/. Accessed 1/10/19.