CIMZIA® (Certolizumab Pegol)

CIMZIA®

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Important Safety Information

CIMZIA® (certolizumab pegol) is a prescription infusion medication that’s known as a tumor necrosis factor (TNF) blocker — which means it helps stop inflammation. It is used to treat patients with severe plaque psoriasis, active psoriatic arthritis, moderate to severe rheumatoid arthritis, moderate to severe Crohn’s disease, active non-radiographic axial spondyloarthritis, and active ankylosing spondylitis.

While effective in treating certain medical conditions, it can also lower your body’s ability to fight infections. Tell your doctor about your medical history, especially if you believe you may have an infection. Symptoms include fever, chills, muscle aches, shortness of breath, warm, red, or painful skin or sores, diarrhea, burning sensation when urinating, blood in phlegm, unintended weight loss, and fatigue. Also, discuss with your doctor any medical conditions that may lower your immune system — including HIV, diabetes, hepatitis B, or an autoimmune disorder.

CIMZIA® may also increase the risk of developing tuberculosis (TB) and could be life-threatening for patients with TB. Therefore, it’s crucial for your healthcare professional to test you for TB before starting treatment.

In addition, CIMZIA® does not mix well with certain medications — especially with Kineret (anakinra), Orencia (abatacept), Rituxan (rituximab), or Tysabri (natalizumab). Tell your doctor about all medications you’re currently taking, regardless of whether they’re prescription, over-the-counter, herbal supplements, or vitamins.

What is the most important information I should know about CIMZIA®?

Taking TNF may increase the risk of certain types of rare cancers, such as lymphoma— especially in children, teenagers, and young adults. Lymphoma is also more likely to occur in patients who have inflammatory diseases, including psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis. Some patients have also reported acquiring certain types of skin cancer. If you have a history of skin cancer, talk with your doctor to discuss your available options.

Side Effects of CIMZIA®

As with any prescription medication, CIMZIA® carries the risk of side effects. The most common ones include:

  • Skin rash
  • Urinary tract infections
  • Flu-like symptoms
  • Upper respiratory infections

In rare cases, more serious side effects could occur. Seek emergency care immediately if you experience any of the following:

  • Symptoms of an allergic reaction — including hives, itchiness, tingling sensation, dizziness, breathing difficulties, and/or swelling of the mouth, tongue, and lips
  • Heart failure — symptoms include shortness of breath and swelling of ankles or feet
  • Immune reactions — symptoms include joint pain, rash on your cheeks or arms which worsen with sun exposure, and/or shortness of breath
  • Blood problems — symptoms include a fever that does not go away, bruising easily, and paleness
  • Nervous system problems — symptoms include dizziness, numbing or tingling, vision problems, and/or weakness in the arms or legs

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

The recommended initial dosage of CIMZIA® is 400 mg. How often to administer it depends on the underlying medical condition and the patient’s body weight.

Please refer to the full prescribing information.