CIMZIA® (Certolizumab Pegol)

CIMZIA®

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What is Cimzia?

Cimzia is a prescription medication used to treat adults for the following conditions:

What are the most important things I should know about Cimzia?

Cimzia lowers the ability of your immune system to fight infections. As a result, some patients who have received the medication have developed serious infections, such as tuberculosis, fungi, bacteria, and infections caused by viruses. Some of these infections have resulted in hospitalizations and death.

Prior to commencing treatment with Cimzia, your healthcare provider should test you for tuberculosis, as well as monitor you closely for signs and symptoms of the condition during treatment. Let your doctor know if you have an infection or symptoms of an infection, such as:

  • Fever
  • Sweat
  • Chills
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Weight loss
  • Warm, red, or painful skin
  • Sores
  • Stomach pain
  • Diarrhea
  • Burning when you urinate
  • Urinating more often than usual
  • Tiredness

Also, let your doctor know if you’re being treated for an infection, have a chronic infection, or get a lot of infections. In addition, notify your healthcare provider if you have diabetes, HIV, a weak immune system, tuberculosis or contact with someone with tuberculosis, hepatitis B or a history of hepatitis B, or use the medications Kineret (anakinra), ORENCIA® (abatacept), RITUXAN® (rituximab), or TYSABRI® (natalizumab).

Tell your doctor if you live, have lived, or traveled to certain countries with a higher risk of contracting tuberculosis.

Do not use Cimzia if you have cancer. People with inflammatory diseases — including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis may be more likely to develop lymphoma.

It may also be possible to develop a rare type of cancer called hepatosplenic T-cell lymphoma — especially in young adult males with Crohn’s disease or ulcerative colitis. It’s also possible to develop skin cancer. Tell your healthcare provider if you notice any changes in the appearance of your skin, including growths, during or after your treatment with Cimzia — especially if you have a history of skin cancer.

What are the common side effects of Cimzia?

Cimzia can cause serious side effects, including:

  • Heart failure
  • Shortness of breath
  • Swelling of ankles or feet
  • Sudden weight gain
  • Allergic reactions — symptoms include skin rashes, swelling or itching of the face, tongue, lips, or throat, or breathing difficulties
  • Hepatitis B reactivation in people who carry the virus — symptoms include skin or eyes look yellow, fatigue, poor appetite, vomiting, pain on the right side of the abdomen
  • New or worsening nervous system problems, such as multiple sclerosis, Guillain-Barre syndrome, seizures, or inflammation of the nerves of the eyes — symptoms may include dizziness, numbness or tingling, problems with your vision, weakness in your arms or legs
  • Blood problems such as your body not making enough blood cells that help fight infections or help stop bleeding — symptoms include a fever that does not go away, bruising or bleeding easily, or looking very pale
  • Immune reactions, including a lupus-like syndrome — symptoms include shortness of breath, joint pain, or a rash on your cheeks or arms that worsens with sun exposure

These are not all of the possible side effects of Cimzia. Talk to your doctor about any side effects that you experience. 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.