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Cyltezo™-biosimilar for Humira® (adalimumab)

Cyltezo is an engineered biologic medication that is “biosimilar” to Humira. It was recently approved for use against rheumatoid arthritis. Biosimilar medications are approved based on the similarity of their action to approved medications. Cyltezo is not commercially available in the US at this time. In clinical studies, Cyltezo helped reduce the signs and symptoms of RA for adults with moderate to severe disease, including by slowing joint damage and improving physical functioning.1

This medication can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1

Cyltezo is also approved for use in other autoimmune diseases, including juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.2

Cyltezo is not available in generic forms. Cyltezo is planned to be available in the United States in 2023.

What are the ingredients in Cyltezo?

The active ingredient in Cyltezo is adalimumab-adbm.3

How does Cyltezo work?

Cyltezo 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.

Cyltezo 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.2

What are the possible side effects of Cyltezo?

Common side effects with Cyltezo include2,3:

  • redness, itching, pain, or swelling at the site of injection
  • upper respiratory infections, including colds and sinus problems
  • headache
  • rash

In some patients, Cyltezo can cause more harmful side effects. Patients who take Cyltezo 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).2,3

Children and adolescents as well as adults taking Cyltezo are also at slightly higher risk for lymphoma and other more unusual cancers. Other rare but serious side effects include Hepatitis B reactivation, nerve diseases like multiple sclerosis, certain blood disorders, new or worsening heart disease, lupus-type symptoms, liver problems, and psoriasis.2,3

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

Before taking Cyltezo, tell your doctor if you3:

  • 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 or had cancer
  • Have any nervous system problems like multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Are scheduled to have surgery
  • Are scheduled to receive a vaccine
  • Are pregnant or plan to become pregnant or are breastfeeding

With Cyltezo, there is an increased risk for serious infection. This is because Cyltezo 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. You will likely need to stop the medication until the infection resolves.2,3

Patients taking this medication should not receive live vaccines. Tell your doctor about any medications or supplements you are taking while on Cyltezo, because it doesn’t mix well with certain medicines. It is important for doctors to test you for TB before you take Cyltezo and to monitor for heart problems, infection, and liver and nerve damage while you are on the medication.3

Dosing information

Cyltezo comes in prefilled syringes and is usually administered by injection under the skin every other week. The recommended dose of Cyltezo is 40 mg.

In patients who are not taking methotrexate at the same time, there may be some benefit to increasing the frequency of Cyltezo dosing to once every week. Your doctor will decide how often you should take this medicine.2

You will be given your first dose of Cyltezo in a medical office, and after that, you may be able to administer it at home. Before injecting Cyltezo, remove the syringe from the refrigerator and place it on a flat surface without removing the cap. Allow it to come to room temperature for 15 to 30 minutes before you inject it. You can inject Cyltezo anywhere on the front of your thighs or stomach, except within 2 inches of your navel. Use a different site for each injection, to reduce soreness at the injection site.2

Make sure you have been instructed about how to give an injection of Cyltezo before you do it yourself. If you have any questions about how to prepare and administer Cyltezo, call your doctor.2

Written by: Emily Downward | Last reviewed: September 2019.
  1. Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm), a biosimilar to Humira®, for the treatment of multiple chronic inflammatory diseases. Boehringer Ingelheim Pharmaceuticals, Inc., Ingelheim, Germany. Published August 29, 2017. Accessed June 15, 2018.
  2. Prescribing Information. Boehringer Ingelheim International GmbH. Ingelheim, Germany. Published August 2017. Accessed June 15, 2018.
  3. Medication Guide. Boehringer Ingelheim International GmbH. Ingelheim, Germany. Published August 2017.;MEDICATION. Accessed June 15, 2018.