Cyltezo
Adalimumab-adbm
Rheumatoid arthritis
Juvenile idiopathic arthritis
Psoriatic arthritis
Ankylosing spondylitis
Crohn’s disease
Ulcerative colitis
Plaque psoriasis
Hidradenitis suppurativa
Uveitis
Tumor necrosis factor (TNF) inhibitor
Subcutaneous injection (injection under the skin)
Injected under the skin
Cyltezo is approved by the Food and Drug Administration (FDA) to treat several inflammatory conditions. These include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
Cyltezo contains the same active drug as Humira (adalimumab). It is a biosimilar that is interchangeable with Humira.
Cyltezo has a boxed warning for serious, life-threatening infections that may require hospitalization. These include tuberculosis (TB), serious fungal infections, and severe bacterial or viral infections.
Cyltezo also has a boxed warning for certain types of cancer. It can raise the risk of developing cancers such as leukemia, lymphoma, and skin cancer.
Cyltezo is an injectable medication that you will administer yourself at home. Your doctor or another healthcare provider will show you how to inject Cyltezo. Be sure to read the Medication Guide and Instructions For Use for complete instructions.
Cyltezo should be stored in the refrigerator in its original carton. If needed, it can be stored at room temperature for up to 14 days.
Fact-check the list of forms below, removing any forms that do not apply to Cyltezo.
Add information about strengths below each form.
Injection
Cyltezo Prefilled Pen 40 mg/0.8 mL
Cyltezo Prefilled Syringe 10 mg/0.2 mL
Cyltezo Prefilled Syringe 20 mg/0.4 mL
Cyltezo Prefilled Syringe 40 mg/0.8 mL
Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
40 mg injected every other week
Juvenile idiopathic arthritis (ages 2 years and older)
10 kg to <15 kg: 10 mg injected every other week
15 kg to <30 kg: 20 mg injected every other week
30 kg and greater: 40 mg injected every other week
Crohn’s Disease (adult)
Day 1: 160 mg injected once
Day 15: 80 mg injected once
Day 29: 40 mg injected every other week
Crohn’s Disease (pediatric, ages 6 years and older)
17 kg to <40 kg
Day 1: 80 mg injected once
Day 15: 40 mg injected once
Day 29: 20 mg injected every other week
40 kg and greater
Day 1: 160 mg injected once
Day 15: 80 mg injected once
Day 29: 40 mg injected every other week
Ulcerative Colitis (adult)
Day 1: 160 mg injected once
Day 15: 80 mg injected once
Day 29: 40 mg injected every other week
Plaque psoriasis or uveitis
Day 1: 80 mg injected once
Day 8: 40 mg injected every other week
Hidradenitis Suppurativa
Day 1: 160 mg injected once
Day 15: 80 mg injected once
Day 29: 40 mg injected weekly or 80 mg injected every other week
Be sure to read the Medication Guide and Instructions For Use that comes with Cyltezo. If you have any questions about how to administer Cyltezo, ask a healthcare provider.
Depending on the condition Cyltezo is being used to treat, your healthcare provider will prescribe your exact dose and tell you how often it should be given. Do not use Cyltezo more often than prescribed.
Examine the Cyltezo pen or prefilled syringe before use. If the solution is milky, discolored, or has flakes or particles in it, do not use it.
Cyltezo should be injected under the skin. You can inject it in an area on your upper thighs or belly. Avoid injecting it within 2 inches of your belly button.
Choose a different site every time you give yourself an injection. Avoid injecting Cyltezo in any areas that are tender, bruised, hard, red, or scarred.
After injection, dispose of used needles and syringes in a sharps container right away. Do not throw away used needles or syringes in your regular trash.
If you miss a dose of Cyltezo, take it as soon as you remember. Then, take the next dose at your regularly scheduled time.
If you have any questions about a missed dose, contact your healthcare provider.
Cyltezo isn’t right for everyone. Do not use it if you’ve had an allergic reaction to adalimumab or any other ingredients in the medication.
Cyltezo can increase your risk of the following:
Serious infections
Certain cancers, such as leukemia, lymphoma, or skin cancer
New or worsening heart failure
If you are a carrier of the hepatitis B virus (HBV), Cyltezo may increase the chances of your virus reactivating.
Cyltezo can cause or worsen certain medical conditions, including multiple sclerosis (MS), optic neuritis, and Guillain-Barre syndrome.
Although it’s rare, Cyltezo can lower your blood cell levels. This can cause bleeding problems and increase your risk of infection.
The needle covers of Cyltezo pens and prefilled syringes contain latex. If you’re allergic to latex, be sure to tell your healthcare provider.
In addition to reviewing/revising the list of side effects below, please add a sentence or two about which side effect(s) warrant a doctor’s visit or ER visit.
Cyltezo can cause mild to severe side effects.
Any signs or symptoms of a serious allergic reaction, including hives, swelling of the hands or face, and shortness of breath, require immediate medical attention. Call 911 or your local emergency number to get medical help right away.
Serious side effects:
Fever, sweat, chills
Muscle aches
Cough
Shortness of breath
Coughing up blood
Warm, red, or painful sores
Diarrhea
Stomach pain
Burning when you urinate
More frequent urination
Fatigue (low energy)
Weight loss
Dark urine
Yellowing skin or eyes
Clay-colored stools
Skin rash
Swelling of your ankles or feet
Sudden weight gain
Poor appetite
Pain, redness, or swelling where Cyltezo is injected that doesn’t go away within a few days
Less serious side effects:
Redness, rash, swelling, itching, or bruising where Cyltezo is injected
Upper respiratory infections
Headache
Cyltezo (adalimumab-adbm) injection (for subcutaneous use), DailyMed (2023)
Sharps disposal containers, Food and Drug Administration (2021)
Tumor necrosis factor (TNF) inhibitors, American College of Rheumatology (2023)
Ashley Wong, Pharm.D., has worked for healthcare companies where she translated complex drug information into easy-to-understand language for patients. She also served as a Senior Medical Information Specialist at a medical communications company, where she delivered clinically accurate drug information to healthcare providers and patients and compiled adverse event reports in accordance with the FDA's reporting guidelines.
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