Cimzia Side Effects & Safety Profile
The safety of Cimzia in patients with RA has been evaluated primarily in randomized, placebo-controlled trials, as well as in long-term follow-up studies. Safety results from these studies reflects drug exposure by 2,367 patients, including 2,030 who received Cimzia for at least 6 months, 1,663 for at least 1 year, and 282 for at least 2 years. The majority of these patients received at least the recommended dose of Cimzia.1
The percentage of RA patients who stopped treatment because of side effects and adverse effects in controlled trials was 5% for Cimzia compared with 2.5% for placebo. Tuberculosis (TB, which occurred in 0.5% of patients) and pyrexia (fever), urticaria (hives), pneumonia, and rash (which each occurred in 0.3% of patients), were the most common causes of discontinuation of treatment. The most serious side effects or adverse effects associated with Cimzia in clinical trials were serious infections, cancers, and heart failure, which occurred in a small minority of patients.1
The most common side effects occurring in at least 3% of patients in randomized, controlled clinical trials of Cimzia 200 mg every other week given in combination with methotrexate included upper respiratory tract infections (6%), headache (5%), hypertension (5%), and nasopharyngitis (5%).
Most common side effects and adverse reactions with Cimzia plus methotrexate (MTX)1*
|Side effect||Cimzia 200 mg every other week + MTX (N=640)||Placebo + MTX (N=324)|
|Upper respiratory tract infection||6%||2%|
|*Occurring in at least 3% of patients in randomized, controlled clinical trials.|
Warnings and precautions with Cimzia
There are several warnings and precautions related to Cimzia you should be aware of before you start treatment.
There is an increased risk for developing serious infections with Cimzia, including TB, bacterial sepsis, invasive fungal infections (fungal infection inside the body) such as histoplasmosis, coccidioidomycosis, or blastomycosis (people who live in the Ohio or Mississippi River Valleys are at increased risk for these types of infections), and other opportunistic infections (infections that result from microorganisms that normally do not cause diseases in humans). The increased risk of infection with Cimzia occurs because the drug can decrease the ability of the immune system to fight infections. If you develop a serious infection while taking Cimzia, you should discontinue the treatment.1
Before starting treatment with Cimzia, you should be tested for latent TB, and, if positive, you should receive treatment for TB before starting Cimzia. All patients should be monitored for active TB during treatment with Cimzia.1
The signs of TB include a cough that persists, a low-grade fever, weight loss, and loss of body fat and muscle.
If you carry the hepatitis B virus (HBV), a virus that affects the liver, HBV may become active during treatment with Cimzia. Before you start treatment with Cimzia, as well as during treatment and for several months after you stop treatment, your doctor will give you a blood test to see if you have HBV infection. The signs of HBV infection include muscle aches, fatigue, yellow-looking skin or eyes, dark urine, clay-colored bowel movements, vomiting, fever, chills, stomach ache, skin rash, and loss of appetite. Tell your doctor if you have any of these symptoms.1
Cimzia and other anti-TNF treatments have been shown to increase the risk of developing certain types of cancers. While this risk is small, it does exist. Cases of lymphoma have occurred in children and adolescents who received anti-TNF treatments.1
Other health conditions
Cimzia can cause a worsening of congestive heart failure (signs include shortness of breath, swelling of feet or ankles, and sudden weight gain), demyelinating disease (such as MS), a Lupus-like autoimmune disorder, or cytopenia (a deficiency of cells that make up blood, with symptoms including bruising, bleeding, or persistent fever). If you experience any of these, contact your doctor immediately.1 Patients diagnosed with multiple sclerosis or other demyelinating disease should not use Cimzia.
Pregnancy and nursing
Cimzia is a pregnancy category B drug. One small study conducted in 10 women who received Cimzia during pregnancy found that there was low transfer of certolizumab pegol through the placenta. Results from animal studies indicated no harm to the fetus when Cimzia was taken during pregnancy. However, because there have been no well-controlled studies in pregnant women, Cimzia should be used during pregnancy only if it is clearly needed.1
It is not known whether Cimzia is excreted into human milk. Because of the risk of adverse effects, women who are taking Cimzia should either not breastfeed their children or discontinue the drug.1
Because of the increased risk for developing infections, you should not take Orencia (abatacept), Kineret (anakinra), or Rituxan (rituximab) while you are taking Cimzia.1
Use of live vaccines should be avoided while taking Cimzia.1