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CIMZIA is indicated for the treatment of adults with moderate to severe rheumatoid arthritis.

Treating RA without the IV

Some treatments for moderate to severe rheumatoid arthritis (RA) are given through an intravenous (IV) infusion in a doctor's office or clinic. CIMZIA is not an infusion, but rather once ready*, is given as an injection (shot) under the skin on the thigh or abdomen in just minutes. CIMZIA can be given by a healthcare provider or administered at home by you or a caring partner.

*For lyophilized formulation: CIMZIA lyophilized powder formulation should be prepared and administered by a healthcare professional. Reconstitution may take up to 30 minutes.

A Treatment Option That Can Offer Flexible Administration

Syringe designed in partnership with OXO Good Grips®.

Syringe designed in partnership with OXO Good Grips®.

CIMZIA comes in 2 forms. One is a powder that is mixed with sterile water by the physician or nurse before being injected and is given only by a doctor or nurse. The other is the CIMZIA prefilled syringe, which is already mixed and ready to inject once it reaches room temperature.** You and your doctor can decide which option is best for you.

If you are able to give yourself shots and are comfortable doing so, you may use the CIMZIA prefilled syringe at home after you have been trained by a doctor or nurse on proper injection techniques. It is also possible for a friend or loved one to be trained to help you with the shot.

**For prefilled formulation: CIMZIA should be at room temperature for about 30 minutes before injection.

For more information about administration options, please see the CIMZIA Medication Guide.

Having a Doctor or Nurse Administer CIMZIA

If you are not able to give yourself shots or are not comfortable doing so, your doctor or nurse can administer CIMZIA in your doctor's office. When CIMZIA is administered by a doctor or nurse, it is given in the powdered form that is mixed with sterile water before being injected. It is important to keep all of your shot and follow-up appointments with your doctor.

CIMZIA Offers Flexible Dosing

After a 4-week initial dosing period, CIMZIA can be taken either every 2 or every 4 weeks, depending on what you and your doctor determine is right for you.

  • Initial Dosing Period (first 4 weeks)
    The recommended dose of CIMZIA for adults with rheumatoid arthritis (RA) is 400 mg (given as 2 shots that are 200 mg each) initially and at week 2 and week 4. Thus, the first 3 doses of CIMZIA are taken every 2 weeks and consist of 2 shots with each dose. Each shot is given in a different area. For example, one shot might be given in the thigh and the other in the abdomen (belly).
  • Maintenance Dosing
    After the first 3 doses, CIMZIA needs to be given as one 200 mg shot every 2 weeks or two 200 mg shots every 4 weeks, depending on what you and your doctor decide is best for you. If CIMZIA is taken every 2 weeks, the dose is a single shot each time. If CIMZIA is taken every 4 weeks, the dose is 2 shots each time. Each shot should be given into a different area. For example, one shot might be given in the thigh and the other in the abdomen (belly).

    Medication Guide & Prescribing Information

Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

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Important Safety Information you should know about CIMZIA® (certolizumab pegol).

What is the most important information I should know about CIMZIA?

CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

  • Your doctor should test you for TB before starting CIMZIA.
  • Your doctor should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.

Certain Types of Cancer

There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. CIMZIA is not approved for use in pediatric patients. For people taking TNF-blocker medicines, including CIMZIA, the chances for getting lymphoma or other cancers may increase. People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

What is CIMZIA?

CIMZIA is a medicine called a Tumor Necrosis Factor (TNF) blocker. CIMZIA is used in adult patients to:

  • Lessen the signs and symptoms of moderately to severely active Crohn's disease (CD) in adults who have not been helped enough by usual treatments.
  • Treat moderately to severely active rheumatoid arthritis (RA).

Before starting CIMZIA, tell your doctor about all of your medical conditions, including if you:

  • think you have an infection. You should not start taking CIMZIA if you have any kind of infection.
  • are being treated for an infection
  • have signs of an infection, such as a fever, cough, flu-like symptoms
  • have any open cuts or sores on your body
  • get a lot of infections or have infections that keep coming back
  • have diabetes
  • have HIV
  • have TB, or have been in close contact with someone with TB
  • were born in, lived in, or traveled to countries where there is more risk of getting TB. Ask your doctor if you are not sure.
  • live or lived in certain parts of country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become severe if you take CIMZIA. If you do not know if you have lived in these types of areas, ask your doctor.
  • have or have had hepatitis B
  • have or have had any type of cancer
  • have congestive heart failure
  • have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis
  • are scheduled to receive a vaccine. Do not receive a live vaccine while taking CIMZIA
  • are pregnant, planning to become pregnant, or breastfeeding. CIMZIA has not been studied in pregnant or nursing women.
  • are allergic to any of the ingredients in CIMZIA.
  • are taking any medicines, including prescription and nonprescription medicines, vitamins and herbal supplements. Your doctor will tell you if it is okay to take your other medicines while taking CIMZIA.
  • Especially tell your doctor if you take:
    Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), Tysabri® (natalizumab). You have a higher chance for serious infections when taking CIMZIA with these medicines.
    A TNF blocker: Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept) or Simponi® (golimumab)

You should not take CIMZIA while you take one of these medicines.

How should I use CIMZIA?

CIMZIA is available as a lyophilized powder for reconstitution or a prefilled syringe. If your doctor prescribes the lyophilized pack, CIMZIA should be injected by a healthcare provider. If your doctor prescribes the prefilled syringe, see the booklet called "Patient Instructions for Use" packaged in your CIMZIA prefilled syringe kit for complete instructions for use. Do not give yourself an injection of CIMZIA unless you have been shown by your doctor or nurse, or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your doctor will tell you how much CIMZIA to inject and how often, based on your condition to be treated. Make sure to keep all of your injection and follow-up appointments with your doctor.

After starting CIMZIA, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse. Patients 65 years of age or older, patients with other long term medical conditions, or taking certain other drugs that affect the immune system, such as corticosteroids or methotrexate, may be at a greater risk of infection.

What are the possible side effects of CIMZIA?

CIMZIA can cause serious side effects including:

  • Heart Failure, including new heart failure or worsening of heart failure you already have. Symptoms include shortness of breath, or swelling of your ankles or feet.
  • Nervous System Problems such as Multiple Sclerosis, seizures, or inflammation of the nerves of the eyes. Symptoms include dizziness, numbness or tingling, problems with your vision, and weakness in your arms or legs.
  • Allergic Reactions. Signs of an allergic reaction include a skin rash, swollen face, or trouble breathing.
  • Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with CIMZIA if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms: feel unwell, poor appetite, tiredness (fatigue), fever, skin rash, or joint pain.
  • Blood Problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that doesn't go away, bruising or bleeding very easily, or looking very pale.
  • Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.

Call your doctor right away if you develop any of the above side effects or symptoms.

The most common side effects of CIMZIA are: upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).

Other side effects have happened in some people including new psoriasis or worsening of psoriasis you already have and injection site reactions. Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with CIMZIA. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the Medication Guide for CIMZIA and discuss it with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information Regarding Fungal Infections

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Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.