What is Cimzia?

Cimzia (certolizumab pegol) is a biologic prescription medication known as a tumor necrosis factor (TNF) blocker, or anti-tnf, indicated to treat adults with a variety of autoimmune conditions. These conditions include:

Moderately to severely active rheumatoid arthritis
Reducing the signs and symptoms of Crohn’s disease
Active psoriatic arthritis (PsA)
Active ankylosing spondylitis
Moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic (whole system) therapy or phototherapy
Active non-radiographic axial spondyloarthritis (nr-axSpA) with clear signs of inflammation

Cimzia is not indicated to treat children.

How does Cimzia work?

Cimzia is indicated to treat the inflammation induced by specific autoimmune conditions. Inflammation can be caused or worsened by a specific protein known as a tumor necrosis factor that is released into your body. Cimzia is able to block the tumor necrosis factor, which in turn reduces the inflammation and symptoms of certain chronic inflammatory disorders.

What doses of Cimzia are available?

Cimzia comes in two forms both for injection:

A 200mg lyophilized powder in a single-dose vial
A 200 mg/mL solution in a single-dose prefilled syringe

How do you use Cimzia?

Follow all directions given by your doctor, prescribing information, product labeling, and Medication Guide. The instructions for use will change depending on whether you are prescribed the prefilled syringe or a lyophilized powder.

If the powder is prescribed, your doctor will do your injection for you. It will be given as one or two separate subcutaneous injections (under your skin).

If, instead, the prefilled syringe is prescribed to you, there are specific at-home steps to follow. Make sure you follow all of their directions and ask your doctor about any questions or concerns that you have.

To start, remove Cimzia from the refrigerator if you are storing it there. Then, allow the syringe to sit at room temperature for at least 30 minutes, but for no more than two hours. Do not heat the vials up any other way. Make sure to rotate your injection site with each dose and avoid injecting in any bruised, red, or swollen areas.

You should not use or inject Cimzia any differently than what is prescribed. If needed, you can carry on taking any non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers, unless your doctor advises otherwise.

What are the side effects of Cimzia?

The most common side effects of Cimzia in clinical trials compared to placebo include:

Upper respiratory infections (flu, cold)
Urinary tract infections (bladder infections)
Skin rash

Rarely, Cimzia may cause some serious side effects. Those could include:

Serious infections, including tuberculosis (Cimzia is an immunosuppressant). Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Monitor for infection throughout your treatment. See the precautions section for more information.
Heart failure. This could include worsening or new heart failure. Monitor for the possible symptoms:
- Shortness of breath
- Quick weight gain
- Swelling in your feet or ankles

Reactivation of Hepatitis B virus that is already in your body.
- This could potentially lead to death. Make sure your doctor monitors you for any signs of the hepatitis B virus.
- Let your doctor or healthcare provider know if you experience:
  - Eyes or skin that look yellow
  - Feel unwell
  - Fatigue (tiredness)
  - Pain in the abdomen (stomach)
  - Vomiting or poor appetite
Problems with your nervous system that are either new or worsening. This could include:
- Multiple sclerosis (MS)
- Seizures
- Guillain-Barre Syndrome
- Nerve inflammation in your eyes
Blood problems
- You are more susceptible to infections because your body is less likely to be able to produce enough blood cells. Call your doctor if you experience bleeding, bruising, or persistent fever.
Immune reactions. This may show up as:
- Trouble breathing
- Joint pain
- Skin rash, specifically on your arms or cheek
Cancer
- Cimzia may increase your chances of getting certain types of cancers, including lymphoma.
- You may be more likely to get lymphoma if you have an inflammatory disease, including psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis.
- Male teenagers and young adults with ulcerative colitis or Crohn’s disease have been found to develop a rare, potentially fatal type of cancer known as hepatosplenic T-cell lymphoma. This was more likely to develop if they were treated with both a TNF blocker and a medicine called Purinethol (6-mercaptopurine, 6-MP) or Imuran (azathioprine).
- Skin cancer has also been found to develop in some people who are taking Cimzia. Tell your doctor or healthcare provider if anything changes in the appearance of your skin, including growths on your skin, during or after treatment with Cimzia. Especially if you have a history of skin cancer, go to your doctor periodically during treatment for skin examinations.

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Cimzia. You can report your adverse effects to UCB, Inc. at 1-866-822-0068 or the Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cimzia drug interactions

When Cimzia is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Cimzia include:

Biological DMARDs.
- Clinical studies found that serious infections were a higher risk between biological DMARDs and a TNF blocker (in this study’s case, etanercept) and did not prove any better results of etanercept alone. Avoid using together.

Boxed warnings

There is a possibility of serious infections and malignancy while taking Cimzia. The increased risk of serious infection leading to death or hospitalization includes:

Tuberculosis (TB)
Bacterial sepsis
Invasive fungal infections (ex: histoplasmosis)
Infections due to other pathogens

If you develop a serious infection or sepsis, Cimzia should be discontinued. If you test positive for TB, start TB treatment before starting Cimzia. Throughout treatment, you should be monitored for active TB, regardless of previous negative TB tests. Lymphoma and other potentially fatal malignancies have been found in children and adolescents that have been treated with TNF blockers. Cimzia has not been indicated to use in pediatric patients.

Cimzia precautions

Before taking Cimzia, you should be sure that your doctor or healthcare provider is aware of all your medical conditions, including if you have:

An infection, either currently being treated for one or think you may have one. Symptoms could include:
- Sweats, fever, or chills
- Cough
- Shortness of breath
- Muscle aches
- Weight loss
- Blood in phlegm
- Diarrhea or stomach pain
- Warm, red, or painful skin or sores on your body
- Feeling very tired
- Urinate more often than normal or burning when you urinate

A history of a lot of infections or infections that keep coming back.
Lymphoma or any other type of cancer.
Diabetes, a weak immune system, or HIV-1.
- If you have these conditions, you have a higher risk of infections.
- If you are in the at-risk group for HIV, your rheumatology team should test you before you start treatment with Cimzia.
An allergy to rubber or latex. The plastic needle shield of the syringe contains natural rubber.
Tuberculosis (TB), or have been in close contact with someone with TB.
- Tell your doctor or healthcare provider if you have lived, currently live, are from, or traveled to certain countries where there is a higher risk of getting TB. Ask your healthcare provider for clarity on whether this applies to you.
- You will take a TB skin test before and while taking Cimzia.
Been to, lived in, or are from certain places in the United States, such as the Ohio and Mississippi River valleys and the Southwest, that have an increased risk of certain kinds of fungal infections (coccidioidomycosis, histoplasmosis, pneumocystosis, candidiasis, aspergillosis, and blastomycosis)
Any numbness or tingling, seizures, or a disease that affects your nervous system, such as Guillain-Barre syndrome or multiple sclerosis.
Hepatitis B.
Congestive heart failure.
Any serious blood conditions.
A scheduled vaccination.
- Do not receive a live vaccine while receiving Cimzia.

Used or are using any of the medications:
- Kineret (anakinra)
- Rituxan (rituximab)
- Orencia (abatacept
- Tysabri (natalizumab)
An allergy or have had an allergic reaction to certolizumab pegol or any of the ingredients in Cimzia. The medication guide has the full list of active ingredients.
A pregnancy, plan to become pregnant, or are breastfeeding.
- It is unknown whether Cimzia affects an unborn baby. Talk to your healthcare provider about what is best for you.

Is there a generic available for Cimzia?

No, Cimzia is a brand-name medication with no generic available in the US.

How do you store Cimzia?

Make sure to keep Cimzia in a refrigerator, storing between 36ºF - 46ºF (2ºC - 8ºC). Make sure not to freeze Cimzia, and protect it from sunlight. Do not use Cimzia if it has expired. You can store Cimzia in the carton it came in. Do not drop or crush the prefilled syringe.