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For Psoriatic Arthritis (PsA)

See why CYLTEZO could help your PsA

CYLTEZO® (adalimumab-adbm) may help reduce signs and symptoms of PsA.

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Study results: safety and effectiveness

About PsA and CYLTEZO

PsA is a type of arthritis that affects some people who have psoriasis. Joint pain, stiffness, and swelling are typical signs and symptoms of psoriatic arthritis. CYLTEZO can help.

CYLTEZO offers patients with PsA the same safety and effectiveness as Humira®.

Clinical Response

58% at week 12 graph

In one clinical study, 58% of patients taking adalimumab experienced 20% improvement in signs and symptoms (based on ACR 20)* at Week 12 compared to 14% of patients taking placebo.

Improvements in PASI score in 2 weeks icon

With adalimumab, signs and symptoms of PsA improved in as little as 2 weeks as measured by the Psoriatic Area and Severity (PASI) score.† Individual results may vary.

75% skin symptom improvement graph

59% of patients taking adalimumab had 75% improvement in skin symptoms (PASI 75) at 24 weeks† (secondary outcome measure) compared to 1% of the patients taking placebo.

90% skin symptom improvement graph

42% of patients taking adalimumab had 90% improvement in skin symptoms (PASI 90)‡ compared to 0% of patients taking placebo.

The most common side effects of CYLTEZO include injection site reactions, upper respiratory infections (including sinus infections), headaches, and rash. The symptoms of injection site reactions such as redness, rash, swelling, itching, or bruising usually will go away within a few days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.

These are not all the possible side effects with CYLTEZO. Tell your doctor if you have any side effect that bothers you or that does not go away.

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*20% improvement in signs and symptoms corresponds to American College of Rheumatology (ACR) 20 response that requires at least 20% improvement in number of tender and swollen joints in addition to a minimum of 20% improvement in 3 of the 5 factors physician’s/patient's assessment of disease activity, pain, physical function, and levels of an acute-phase reactant.

†Improvements in skin symptoms were evaluated by Psoriasis Area and Severity Index (PASI) 75 response, which reports percentage of patients who achieved at least 75% reduction in the PASI score. PASI score measures the severity and extent of psoriasis.

‡Improvements in skin symptoms were evaluated by PASI 90 response, which reports percentage of patients who achieved at least 90% reduction in the PASI score. PASI score measures the severity and extent of psoriasis.

What is CYLTEZO?

This important information also applies to Adalimumab-adbm injection for subcutaneous use.

CYLTEZO is a medicine called a tumor necrosis factor (TNF) blocker. CYLTEZO is used:

  • To reduce the signs and symptoms of:
  • moderate to severe rheumatoid arthritis (RA) in adults. CYLTEZO can be used alone, with methotrexate, or with certain other medicines.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. CYLTEZO can be used alone or with methotrexate.
  • psoriatic arthritis (PsA) in adults. CYLTEZO can be used alone or with certain other medicines.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe hidradenitis suppurativa (HS) in adults.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
  • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) 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).
  • To treat non-infectious intermediate, posterior, and panuveitis in adults.
Important Safety Information for CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use

This important information also applies to Adalimumab-adbm injection for subcutaneous use.

What is the most important information I should know about CYLTEZO?

You should discuss the potential benefits and risks of CYLTEZO with your doctor. CYLTEZO is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking CYLTEZO if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting CYLTEZO and check you closely for signs and symptoms of TB during treatment with CYLTEZO, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
  • Cancer. For children and adults taking TNF blockers, including CYLTEZO, the chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including CYLTEZO, your chances of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting CYLTEZO?

Tell your doctor about all of your health conditions, including if you:

  • Have an infection, are being treated for infection, or have symptoms of an infection.
  • Get a lot of infections or have infections that keep coming back.
  • Have diabetes.
  • Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB.
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use CYLTEZO. Ask your doctor if you are unsure whether you have lived in an area where these infections are common.
  • Have or have had hepatitis B.
  • Are scheduled for major surgery.
  • Have or have had cancer.
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome.
  • Have or had heart failure.
  • Have recently received or are scheduled to receive a vaccine. CYLTEZO patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting CYLTEZO.
  • Are allergic to rubber or latex.
  • Are allergic to any CYLTEZO ingredients.
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
  • Have a baby and you were using CYLTEZO during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

Also tell your doctor about all the medicines you take. You should not take CYLTEZO with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab),
ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN®
(azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting CYLTEZO?

CYLTEZO can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss,
    or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite,
    vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very
    easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions, including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach
    (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

The most common side effects of CYLTEZO include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus
infections), headaches, and rash. These are not all the possible side effects with CYLTEZO. Tell your doctor if you have any side effect that bothers you or that does
not go away.

Remember to tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, or chills
  • Muscle aches
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Warm, red, or painful skin or sores on your body
  • Diarrhea or stomach pain
  • Burning when you urinate
  • Urinating more often than normal
  • Feeling very tired
  • Weight loss

These are not all the possible side effects of CYLTEZO. For more information, speak with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-CTZ-100017 SEPT 2023