Cimzia (certolizumab) reduces the effects of a substance in the body that can cause inflammation.
Cimzia is used to treat the symptoms of Crohn’s disease after other drugs have been tried without successful treatment of symptoms. Cimzia is also used to treat moderate to severe rheumatoid arthritis in adults.
Cimzia may also be used for purposes not listed in this medication guide.
You should not receive Cimzia if you have active but untreated tuberculosis. Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common. Some people using Cimzia have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using Cimzia or similar medicines to treat Crohn’s disease or ulcerative colitis.
However, people with autoimmune disorders (including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
To make sure you can safely use Cimzia, tell your doctor if you have any of these other conditions:
- an active or recent infection;
- signs of infection such as fever, chills, cough, or flu symptoms;
- open sores or skin wounds;
- HIV or AIDS;
- hepatitis B (or if you are a carrier of the virus);
- a history of cancer;
- epilepsy or seizure disorder;
- congestive heart failure;
- a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;
- if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
- if you are scheduled to receive any vaccines.
FDA pregnancy category B. Cimzia is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether certolizumab passes into breast milk. Before you receive Cimzia, tell your doctor if you are breast-feeding a baby.
Get emergency medical help if you have any of these signs of an allergic reaction to Cimzia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
- shortness of breath with swelling of your ankles or feet;
- chest pain, ongoing cough, coughing up blood or mucus;
- swollen glands in your neck, armpits, or groin;
- fast or slow heart rate;
- pain or burning when you urinate;
- confusion, neck stiffness, seizure (convulsions);
- severe blistering, peeling, and red skin rash;
- vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
- joint pain or swelling with fever, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions); or
- patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious Cimzia side effects may include:
- stuffy nose, sinus pain;
- stomach pain, mild diarrhea, constipation; or
- pain, redness, itching, swelling, or bleeding where the medicine was injected.
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.