What to Know About Cimzia (Certolizumab Pegol)

A TNF Blocker for Rheumatoid Arthritis, Crohn’s Disease, and Psoriasis

In This Article

Cimzia is an injectable, biologic treatment used to treat plaque psoriasis, Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and some other medical conditions. Though these conditions affect different parts of the body, they are all inflammatory diseases in which the immune system is acting abnormally. Cimzia blocks an immune signaling marker called TNFα (tumor necrosis factor α), making it a member of a group of treatments called TNFα inhibitors (These are also sometimes called TNF inhibitors or TNF blockers.) Cimzia is the brand name for certolizumab pegol.

Uses

Cimzia is used to treat a number of different diseases in rheumatology, dermatology, and gastroenterology that affect the body’s inflammatory pathways. Cimzia is approved for:

  • Moderate to severe Crohn’s disease
  • Moderate to severe rheumatoid arthritis
  • Active psoriatic arthritis
  • Moderate to severe plaque psoriasis
  • Active ankylosing spondylitis (radiographic axial spondyloarthritis)
  • Active non-radiographic axial spondyloarthritis

For all of these conditions, Cimzia has been approved only for adults and not for children.

Off-Label Uses

Cimzia and other TNF inhibitors are also sometimes prescribed for other conditions affecting the immune system when a clinician has good reason to think that they might help. We might have limited information that TNF inhibitors might be helpful from basic laboratory work or from studies in a small number of people. But there might not be enough data from clinical trials for the FDA to approve Cimzia. In this case, a clinician might prescribe the treatment off-label and see how the person responds.

For example, people with some of the following conditions might be prescribed a TNF inhibitor such as Cimzia:

  • Behcet’s disease
  • Sarcoidosis
  • Noninfectious uveitis
  • Graft versus host disease
  • Juvenile idiopathic arthritis

In certain circumstances, you might be prescribed Cimzia for a medical condition for which another TNF inhibitor is approved, but not Cimzia. For example, some other TNF inhibitors are approved to treat ulcerative colitis, but Cimzia hasn't gone through the FDA approval process for this condition.

Cimzia may also be prescribed off-label for children or adolescents.

Before Taking

Your clinician will need to give you a thorough medical evaluation before starting Cimzia. You’ll need to talk about any current symptoms you are having. For example, if you have signs or symptoms of an ongoing infection, you should wait to start Cimzia. Your clinician will also want to assess your disease status. For example, if you are responding well to your current treatments, trying Cimzia probably won't make sense.

You’ll also need to talk about your medical history. For example, your clinician should ask about whether you’ve had health conditions like heart failure, lymphoma, diabetes, or tuberculosis. Having these won't necessarily mean that you can't take Cimzia, but you'll need to weigh the pros and cons in your situation. Working together, you and your clinician will make sure that Cimzia is the best option for you.

Sometimes, doctors want to run additional blood tests to make sure you don't have a medical issue that might be an issue with Cimzia. For example, these might include a CBC (to check for infection and other factors) and a comprehensive metabolic panel. If you have risk factors, you also might need an HIV test.

It’s likely that Cimzia will not be the first treatment that you try for your medical condition. In some cases, other treatments are available that should be used first. These therapies might be less expensive than Cimzia, and they might not have some of the same risks. For example, people with Crohn’s disease usually only start Cimzia after they have tried other therapies, like corticosteroids and 5-aminosalicylic acid.

Precautions and Contraindications

People starting Cimzia need to get a test for tuberculosis (a TB test) before starting treatment. This might involve getting a chest x-ray or a TB skin test. Some people have dormant infections that aren’t giving them any symptoms. But because of the way it affects the immune system, starting Cimzia might make a TB infection more active. Let your doctor know if you have spent time in certain countries where TB is more common.

If you do have a TB infection, you’ll need to be treated before you start Cimzia. You’ll also need to occasionally be checked for TB while you continue taking it.

Similarly, some people may have an infection with a hepatitis virus and not know it. In this case, starting Cimzia might make that infection more active. Before treatment, your doctor should test to make sure you aren’t infected with the hepatitis B or hepatitis C virus. If you are infected, you still may be able to take Cimzia, but your doctor will need to monitor you for reactivation of the virus. That way, you could be treated for it promptly if the virus does become active.

You also may not be able to start taking it right away if you’ve recently taken certain kinds of vaccines. You also shouldn’t get this type of vaccine (called a “live vaccine”) while you are taking Cimzia.

People who have had a serious allergic reaction to Cimzia in the past also should not take it.

Special Populations

Talk to your doctor if you are pregnant, thinking of becoming pregnant, or are breastfeeding. Some studies suggest that Cimzia does not increase the risk of birth defects or death of the fetus, but the potential risks should be weighed with your healthcare provider.

Cimzia hasn’t been well studied in people over the age of 65. Because older people tend to have more medical conditions and increased risk of infection, a decision to start Cimzia should be made thoughtfully in older adults.

Cimzia should also be used cautiously in people who have diabetes, HIV, or other issues that can impair the immune system.

Other TNF Inhibitors

The following are also TNF inhibitors::

  • Enbrel (etanercept) (injected under the skin)
  • Humira (adalimumab) (injected under the skin)
  • Infliximab (remicade) (given as an infusion)
  • Simponi (golimumab) (injected under the skin or given as infusion)

These treatments are approved for similar conditions as Cimzia. They share a number of overlapping side effects and are roughly comparable in their safety. However, they may differ somewhat in their cost. Only limited information is available about which of the treatments in this class might be the most effective in different medical conditions.

In the laboratory, Cimzia is prepared somewhat differently than the other TNF inhibitors. This process is called pegylation. (That’s where the “pegol” in “certolizumab pegol” comes from.) This may change the way the therapy moves around in your body compared to other TNF inhibitors, but it might or might not be more effective for you.

Before you decide to start taking Cimzia, you should discuss all your other therapy options (including other TNF inhibitors) with your medical provider.

Dosage

Cimzia is usually given with an initial dose of 400 milligrams (mg). This is given as two separate injections of 200 mg each. This is repeated two weeks later and then two weeks after that. After this initial period, a person might be given 200 mg every other week or 400 mg every four weeks. [Please note that all listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.]

How to Take and Store

Injection

You’ll need to receive training from a nurse, doctor, or other health care professional about how to take Cimzia. Cimzia is given as an injection under the skin. Some people can learn how to give themselves the injection at home, but other people might need to have this done in a healthcare setting.

The pre-filled syringes of Cimzia are stored in the refrigerator, but you need to bring them to room temperature before injection. First you clean the injection site with an alcohol swab. This will be a spot on your belly or upper thighs. You want to avoid areas that are tender and red, and you need to change the site you use with repeat injections. You insert the needle in the fat beneath your skin and push the plunger to empty the syringe. Then you place a dry cotton ball or bandage over the injection site for a few seconds.

You’ll need to go through this process once if you are giving yourself a 200 mg dose, but you’d need to inject a second pre-filled syringe if you are getting a 400 mg dose. You can check out this injection training video.

Don’t skip a scheduled dose even if you are feeling better. And don’t double up a dose if you miss one. Instead, call your doctor’s office for guidance. Call your doctor’s office right away if you accidentally take more than recommended.

Taking Other Treatments With Cimzia

Depending on the context, you might or might not take Cimzia in addition to other medications. For example, some people with rheumatoid arthritis take it by itself, but others take it in addition to medications like methotrexate. However, it is not recommended that Cimzia be taken along with other biologic treatments. 

Side Effects

Common

Upper respiratory tract infection is one of the most common potential side effects from Cimzia. This might lead to symptoms like runny nose and cough. Rash is another frequent side effect. Urinary tract infections are also not uncommon. This might cause symptoms like a burning sensation when you urinate.

Severe

Less commonly, Cimzia can cause severe side effects. These include:

  • Heart failure
  • Demyelinating disease
  • Lupus-like syndrome
  • Reactivation of Hepatitis B virus
  • Reactivation of tuberculosis

Warnings and Interactions

Cimzia has a blackbox warning about the risk of serious infections while using Cimzia. It also contains a warning about a potential increased risk of certain cancers in people who take Cimzia. Both of these potential concerns apply to all the therapies in the TNF inhibitor category and not just Cimzia.

Risk of Cancers and Lymphomas

Because of the way Cimzia alters the immune system, some researchers have expressed concern that Cimzia and other TNF inhibitors might increase one’s risk of cancer. Some findings from laboratory research in animals showed that TNF inhibitors might theoretically increase cancer risk. Additionally, in some early studies, TNF inhibitors seemed to increase the risk of lymphomas and some cancers in some children given the treatment.

This research issue hasn’t been completely settled. Some studies have implied that drugs like Cimzia may not increase your risk at all. If taking TNF inhibitors does increase the risk of cancers or lymphomas, it is probably only a very small increase. Don’t hesitate to talk to your doctor about all your concerns about this potential issue.

Risk of Serious Infection

Cimzia and other TNF inhibitors can also increase your risk of infection, including some infections that might be serious. Because of the way Cimzia affects your body’s immune system, it’s possible that your body will have a harder time fighting off certain kinds of infections. An example might be a serious fungal infection that requires hospitalization for treatment. You may have a higher risk of such an infection if you are over the age of 65, if you are taking other drugs that affect the immune system, or if you have additional health conditions.

The risk of serious infection seems to peek at about three months after starting therapy, decreasing over time. However, you will have an increased risk of such infections for as long as you continue the therapy.

It’s important to keep these risks in perspective. Though Cimzia does carry certain risks, it can be a very helpful therapy for some people. Weigh the pros and cons in your particular situation with your healthcare provider.

See your doctor right away if you have any potentially serious symptoms, such as shortness of breath, bloody cough, fever and chills, numbness or tingling or your extremities, or painful sores on your body. Call 911 for life-threatening symptoms such as sudden difficulty breathing after injection.

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