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Cyltezo

Pronunciation: sil-TEE-zoh
Generic name: adalimumab-adbm
Dosage forms: subcutaneous injection Cyltezo Pen (40 mg/0.8 mL), Cyltezo Prefilled Syringe (40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL)
Drug class: TNF alfa inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 26, 2024.

What is Cyltezo?

Cyltezo (adalimumab-adbm) is an interchangeable biosimilar of Humira; it is a TNF alfa inhibitors used to reduce pain, inflammation, and skin symptoms in autoimmune conditions. Cyltezo Is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis

Cyltezo is the first interchangeable biosimilar to Humira. Biosimilars are biologic medicines that are a very close copy to the original product made by another company. An interchangeable biosimilar has undergone an additional Interchangeability Study, meaning that patients can be confident in the safety and effectiveness of the interchangeable biosimilar product, just as they would be for the FDA-approved original product, in this case, Humira. Being an interchangeable biosimilar means Cyltezo can automatically be substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.

Cyltezo is used to treat chronic autoimmune conditions. Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor (TNF) is a protein that is involved in causing inflammation. Cyltezo is a TNF blocker that inhibits TNF, helping to reduce pain, inflammation, and skin symptoms.

What is Cyltezo used for?

Cyltezo is an FDA-approved medicine to be used for: 

Cyltezo side effects

Common Cyltezo side effects

Common side effects of Cyltezo may include:

Get emergency medical help if you have any of these signs of an allergic reaction to Cyltezo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of lymphoma:

Also call your doctor at once if you have:

Older adults may be more likely to develop infections or cancer while using Cyltezo.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings 

Cyltezo affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with Cyltezo, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for tuberculosis (TB) before starting to take Cyltezo and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting cancer may be increased for children and adults taking TNF-blockers.

Do not take Cyltezo if are allergic to the active ingredient adalimumab or to any of the inactive ingredients. Click here for a list of Cyltezo ingredients

Latex allergy warning. The needle cap of the Prefilled Pen and Prefilled Syringe contains natural rubber latex

Before taking this medicine

Before you start using Cyltezo, tell your doctor if you have signs of infection - fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Cyltezo should only be used in age groups for the specific conditions that Cyltezo is FDA-approved to treat. Children using Cyltezo should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common in certain areas of the world.

Cyltezo may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

It is not known whether Cyltezo will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used Cyltezo while you were pregnant, and especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using Cyltezo. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

How should I use Cyltezo?

Use Cyltezo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Cyltezo is injected under the skin (subcutaneous injection) using a prefilled pen or a prefilled syringe.

The dose schedule for Cyltezo will depend on the severity and the condition that you are treating. Follow your doctor's dosing instructions very carefully.

A healthcare provider will teach you how to properly use Cyltezo by yourself. Do not use this medicine if you do not fully understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

Do not use this medicine if you have any signs of an infection. Call your doctor for instructions.

Prepare your injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Leave the prefilled pen or prefilled syringe at room temperature 68°F to 77°F (20°C to 25°C) for 15 to 30 minutes to allow it to warm up.  Do not warm the Prefilled Syringe using heat sources such as hot water or a microwave.

Choose an injection site. You may inject into the front of your thighs, your abdomen except for the 2 in (5 cm) around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1 inch (3 cm) away from the injection site you used before.

Do NOT inject in skin that is red, hard, tender, damaged, bruised, or scarred, and do NOT inject through your clothes.

Cyltezo affects your immune system so you may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

The dose and frequency of Cyltezo given is dependent on age, severity, and condition treated. For more information on specific dosing schedules click the link below.

Cyltezo is available as:

What happens if I miss a dose?

If you forget to take your dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject your medicine call your doctor or pharmacist. 

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Cyltezo?

Do not inject into skin that is bruised, red, tender, or hard.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Cyltezo. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What other drugs will affect Cyltezo?

Some drugs should not be used together with Cyltezo. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Cyltezo especially:

Avoid the use of live vaccines.

This list is not complete. Other drugs may interact with Cyltezo including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed.

Ingredients

Active ingredient: adalimumab-adbm

Inactive ingredients:  glacial acetic acid, polysorbate 80, sodium acetate trihydrate, trehalose dihydrate, and Water for Injection.

Latex allergy warning. The needle cap of the Prefilled Pen and Prefilled Syringe contains natural rubber latex.

Storage 

Manufacturer

Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Popular FAQ

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Amjevita is not yet interchangeable with Humira, and the pharmacist must get approval from your doctor before they can substitute it for Humira. To date, the only approved interchangeable biosimilar for Humira is Cyltezo, which was granted this status by the FDA in October 2021. Cyltezo will be commercially available July 1, 2023. Continue reading

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.