Skip to Accessibility Tools Skip to Content Skip to Footer

Cyltezo® (adalimumab-adbm)

Cyltezo is a biosimilar to Humira® (adalimumab) that is approved to treat ankylosing spondylitis (AS). Biologic medications are generally used in the treatment of AS which has not been adequately managed with NSAIDs (non-steroidal anti-inflammatory drugs). Cyltezo is also approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.1

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 Cyltezo?

The active ingredient in Cyltezo is adalimumab-adbm, a monoclonal antibody that blocks tumor necrosis factor-alpha (TNF-alpha).1

How does Cyltezo work?

Cyltezo blocks the action of tumor necrosis factor-alpha (TNF-alpha). TNF is an important immune system signaling factor (called a cytokine) that plays a key role in the inflammatory process in the body. In people with AS, there is an excess or abnormal inflammatory response and elevated levels of TNF, causing pain and stiffness in the joints. Cyltezo is a monoclonal antibody that binds to TNF-alpha blocking its action. By blocking TNF, Cyltezo can help relieve the signs and symptoms of AS by reducing the inflammation in the body.1

What are the possible side effects of Cyltezo?

Because TNF is involved in the normal immune response of inflammation, taking a TNF blocker like Cyltezo can make it harder to fight certain infections. Cyltezo may cause serious infections, including tuberculosis (TB), bacterial sepsis, and invasive fungal infections, viral infections, or other opportunistic infections. Serious infections may lead to hospitalization or death.1

TNF blockers like Cyltezo can increase the risk of developing certain cancers, including skin cancers and lymphoma. Some people taking TNF blockers have developed a rare, aggressive form of cancer called hepatosplenic T-cell lymphoma, which often leads to death.1

Cyltezo may cause a serious allergic reaction. Patients who experience hives, trouble breathing, or swelling of the face, lips, or mouth should seek immediate medical attention.

The most common side effects experienced by patients taking Cyltezo include infections (like upper respiratory infections and sinusitis), reactions to the injection site (pain, redness, rash, swelling, itching, or bruising), headaches, and rash.1

This is not an exhaustive list of all potential side effects of Cyltezo. 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 Cyltezo

Before starting treatment with Cyltezo, patients should talk to their doctors about all their medical conditions, especially if they1:

  • Have any signs of infection (fever, chills, cough, muscle aches, shortness of breath, sores, diarrhea, burning during urination) or are prone to frequent infections
  • Have any open cuts or sores
  • Have diabetes
  • Tested positive for TB or have been in close contact with someone who has TB
  • Were born in, lived in, or traveled to countries where there is an increased risk of TB (ask your doctor if you aren’t sure)
  • Live in areas of the US (like the Ohio and Mississippi River valleys) where known for fungal infections
  • Have or have had hepatitis B
  • Have any nervous system problems like multiple sclerosis or Guillain-Barré syndrome
  • Have or have had cancer
  • Are scheduled to have surgery
  • Have or have had heart failure
  • Are scheduled to receive a vaccine
  • Are pregnant or plan to become pregnant or are breastfeeding

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

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

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

Patients taking Cyltezo should not receive live vaccines.1

During treatment with Cyltezo, patients should be monitored for any possible heart problems, anemia, infection, cancers, and nerve damage.1

Dosing information

Cyltezo is an injection given under the skin (subcutaneously). For AS, it is generally given every other week. Patients should talk to their doctor about any questions on their dosing regimen.1

Written by: Emily Downward | Last reviewed: February 2019
  1. Cyltezo prescribing information. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761058lbl.pdf. Accessed 1/16/19.
  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.