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: 

• rheumatoid arthritis (moderate to severe) in adults to reduce the signs and symptoms of RA slow the progression of structural damage, and to improve physical function.
• juvenile idiopathic arthritis (moderate to severe polyarticular) for children 2 years and older, to reduce the signs and symptoms of moderately to severely active polyarticular JIA.
• psoriatic arthritis in adults to be used to reduce the signs and symptoms of psoriatic arthritis and slow the progression of structural damage, and to improve physical function.
• ankylosing spondylitis in adults to reduce signs and symptoms.
• hidradenitis suppurativa (moderate to severe) in adults. 
• Crohn’s disease (moderate to severe) in adults and children 6 years of age and older. 
• ulcerative colitis (moderate to severe) in adults. It is not known if Cyltezo products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. 
• plaque psoriasis (chronic and severe) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). 
• uveitis (UV) that is non-infectious intermediate, posterior, and panuveitis, for adult patients.

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

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.

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:

• Cyltezo Pen (40 mg/0.8 mL) 
• Cyltezo Prefilled Syringe Injection (40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL)

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:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (Cyltezo can cause hepatitis B to come back or get worse);
• diabetes;
• heart failure;
• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• an allergy to latex rubber;
• if you are scheduled to have major surgery; or
• if you have recently received or are scheduled to receive any vaccine.

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.

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. 

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

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).

Common Cyltezo side effects

Common side effects of Cyltezo may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling where the injection was given.

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.

Serious Cyltezo side effects

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

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

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

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:

• abatacept, etanercept;
• anakinra;
• azathioprine, 6-mercaptopurine; or
• certolizumab, golimumab, infliximab, rituximab.

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.