What to Know About Cimzia (Certolizumab Pegol)

Cimzia (certolizumab pegol) is an injectable biologic treatment for autoimmune diseases such as rheumatoid arthritis (RA), plaque psoriasis, Crohn’s disease, and ankylosing spondylitis (AS). Like other TNF inhibitors, it works to relieve inflammation and slow disease progression by blocking tumor necrosis factor αlpha (TNF-α)—an immune-signaling marker that, when present in high levels, can lead to chronic inflammation and persistent symptoms. With this, Cimzia "short circuits" the disease process.

Uses

Cimzia is prescribed to treat a number of different rheumatological, dermatological, and gastroenterological diseases that affect the body’s inflammatory pathways.

The U.S. Food & Drug Administration (FDA) has approved Cimzia for the treatment of:

• 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

Cimzia is approved for use in adults only.

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.

Off-label uses are typically considered when there is some evidence to suggest TNF inhibitors might be helpful for certain conditions, but there's not yet enough clinical trial data for FDA approval for that particular use.

Some off-label uses for TNF inhibitors such as Cimzia:

• Behçet's disease
• Sarcoidosis
• Noninfectious uveitis
• Graft versus host disease
• Juvenile idiopathic arthritis

Your healthcare provider may also prescribe Cimzia for conditions for which another TNF inhibitor is approved. 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 is also prescribed off-label for children or adolescents.

Before Taking

Cimzia is not typically the first drug prescribed for most conditions. For example, in RA, Cimzia would be considered after treatment with methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs) have failed.

Similarly, in Crohn’s disease people usually only start Cimzia after other therapies, like corticosteroids and 5-aminosalicylic acid, have not produced adequate results.

Prior to prescribing Cimzia, your healthcare provider will go over your medical history including your current symptoms and previous treatment regimens. Tell your healthcare provider if you have or have had any of the following:

• Symptoms of an ongoing infection or a history of chronic infections, such as cold sores
• Heart failure
• Lymphoma or other cancers
• Diabetes
• Tuberculosis
• Hepatitis B
• Human immunodeficiency virus (HIV)
• An immune system disorder
• Multiple sclerosis
• Guillain-Barré syndrome
• Optic neuritis
• Numbness, burning, or tingling in any part of your body
• Bleeding problems or blood disorders

In addition, tell your healthcare provider if you live or have ever lived abroad or in areas such as the Ohio and Mississippi River valleys and the Southwest, where severe fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis) are more common.

Your healthcare provider will perform skin tests to check for tuberculosis and run blood tests to check your cholesterol levels, liver enzymes, blood cell counts, and HIV and hepatitis B and hepatitis C status.

You may also need to update your vaccinations prior to treatment with Cimzia, as live-virus vaccines must be avoided while taking the drug. These vaccines include:

• FluMist influenza nasal spray
• Measles, mumps, and rubella
• Yellow fever

Precautions and Contraindications

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

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

Cimzia hasn’t been well studied in people over the age of 65. Because older people tend to have more medical conditions and an 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

TNF inhibitors are used to treat inflammatory conditions.

Other TNF inhibitors include:

• Enbrel (etanercept)
• Humira (adalimumab)
• Remicade (infliximab)
• Simponi (golimumab)

TFN inhibitors share a number of overlapping side effects and are roughly comparable in their safety. The main difference is that Cimzia is prepared using a process called pegylation, which alters the molecular weight of the medicine, increasing stability and allowing it to circulate longer than other TNF inhibitors. This may or may not make the drug more effective for you.

Dosage

Cimzia comes as a 200-milligram (mg) pre-filled syringe to use at home, as well as a powder that is mixed with sterile water and administered in your healthcare provider's office.

An initial dose of Cimzia is usually 400 mg given as two separate injections (200 mg each). The 400 mg dose is repeated in this fashion two weeks later and then again two weeks after that.

After this initial period, maintenance doses are given as either 200 mg every other week or 400 mg every four weeks.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your healthcare provider to make sure you are taking the right dose for you.

How to Take and Store

Cimzia is given as an injection under the skin. Your healthcare provider will teach you how to administer the injection at home.

The pre-filled syringes of Cimzia are stored in the refrigerator. Take the medicine out and let it warm up to room temperature before injection.

To take the injection:

• Choose an injection site. Avoid areas that are tender and red, and rotate your injection sites.
• Clean the injection site (commonly a spot on your abdomen or upper thigh) with an alcohol swab.
• Insert the needle in the fat beneath your skin and push the plunger to empty the syringe.
• Place a dry cotton ball or bandage over the injection site for a few seconds.

If you are scheduled to take a 400-mg dose, you'll repeat the process with a second pre-filled syringe. Choose a new injection site for this dose.

Once you are done, discard the used syringes in a puncture-resistant container. Do not reuse Cimzia pre-filled syringes and do not recap the syringes after use.

Side Effects

Side effects of Cimzia are similar to those of other TFN inhibitors.

Common

Cimzia may cause mild to serious side effects, which include:

• Redness, itching, pain, or swelling at the site of injection
• Headache
• Back pain
• Upper respiratory infections
• Urinary tract infections

If any of these side effects are severe or do not resolve in a few days, call your healthcare provider.

Severe

Less commonly, Cimzia can cause severe side effects. If you experience any of the following, seek immediate medical help:

• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Shortness of breath
• Difficulty swallowing or breathing
• Chest pain
• Sudden weight gain
• Hives
• Hot flashes
• Dizziness or fainting
• Rash, especially on the cheeks or arms that worsens in the sun
• Unusual bruising or bleeding
• Pale skin
• Blistering skin
• Extreme tiredness
• Numbness or tingling
• Problems with vision
• Weakness in the arms or legs
• New or worsening joint pain
• Loss of appetite
• Red scaly patches and/or pus-filled bumps on the skin

Warnings and Interactions

Cimzia and other TFN inhibitors may reduce your ability to fight infection and may lead to a serious or life-threatening fungal, bacterial, or viral infection requiring hospitalization. This risk increases in people who are over the age of 65, are taking other immune-suppressing drugs, have additional health conditions, or are at increased risk of serious infections.

The risk of infections seems to peak about three months after starting therapy and decreases over time. However, you will continue to be at increased risk of such infections for as long as you continue taking Cimzia.

In animal studies, TNF inhibitors appear to increase cancer risk. TNF inhibitors may also increase the risk of lymphomas and some cancers in children. However, other research suggests there is no increased risk, or if there is an increased risk of cancers or lymphomas, it is very small.

Additional warnings include:

• New or worsening heart failure
• Allergic reactions
• Immune reactions such as lupus-like syndrome
• Reactivation of hepatitis B virus
• Reactivation of tuberculosis
• New or worsening nervous system problems, such as multiple sclerosis (MS), Guillain-Barré syndrome, seizures, or inflammation of the nerves of the eyes
• Bleeding problems and blood disorders
• Lymphoma and other cancers

Interactions

Cimzia may be prescribed along with other medications to treat your condition, including non-steroidal anti-inflammatory drugs (NSAIDs), prednisone, methotrexate, and Plaquenil (hydroxychloroquine).

Do not take Cimzia with other TNF blockers or biologic drugs. In addition to the TNF inhibitors listed above, drugs you should not mix with Cimzia include:

• Actemra (tocilizumab)
• Kineret (anakinra)
• Rituxan (rituximab)
• Xeljanz (tofacitinib)