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

You should not start receiving CIMZIA if you have any kind of infection unless your healthcare provider says it is okay.

Before you receive CIMZIA, tell your healthcare provider if you:

• think you have an infection, flu-like symptoms, or have any other symptoms of an infection such as:
  • fever, sweat, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm

  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feeling very tired
• are being treated for an infection, or get a lot of infections or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have tuberculosis (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 healthcare provider if you are not sure.
• live or have lived in certain parts of the 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 more severe if you take CIMZIA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your healthcare provider.
• have or have had hepatitis B
• use the medicine Kineret^® (anakinra), Orencia^® (abatacept), Rituxan^® (rituximab), or Tysabri^® (natalizumab)

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 healthcare provider right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.

Cancer

• For people taking TNF-blocker medicines, including CIMZIA, the chances of getting lymphoma or other cancers may increase.
• There have been cases of cancers in children, teenagers, and young adults who received TNF-blocker medicine that do not usually happen in people this age. CIMZIA is not approved for use in pediatric patients. People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• Some people receiving TNF-blocker medicines, including CIMZIA, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers and young males with Crohn's disease or ulcerative colitis. Also, most of these people had been treated with both a TNF-blocker medicine and another medicine called IMURAN^® (azathioprine) or PURINETHOL^® (6-mercaptopurine, 6-MP).
• If you use TNF-blocker medicine, including CIMZIA, your chance of developing certain kinds of skin cancer may increase. Tell your healthcare provider if any changes in the appearance of your skin, including growths on your skin, happen during or after your treatment.

What is CIMZIA?

CIMZIA is a prescription 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 patients who have not been helped enough by usual treatments.
• Treat moderately to severely active rheumatoid arthritis (RA).
• Treat active psoriatic arthritis (PsA).
• Treat active ankylosing spondylitis (AS)

What should I tell my healthcare provider before starting treatment with CIMZIA?

CIMZIA may not be right for you. Before starting CIMZIA, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• 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 allergic to any of the ingredients in CIMZIA.
• are pregnant or planning to become pregnant. It is not known if CIMZIA will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving CIMZIA.

  Pregnancy Registry: If you become pregnant while taking CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA. You can enroll in this registry by calling 1-877-311-8972. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.

• are breastfeeding or plan to breastfeed. It is not known if CIMZIA passes into your breast milk. You and your healthcare provider should decide if you will receive CIMZIA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take the following medicines due to a higher chance for serious infections:

• Kineret^® (anakinra), Orencia^® (abatacept), Rituxan^® (rituximab), or Tysabri^® (natalizumab)
• medicines called Tumor Necrosis Factor (TNF) blockers, such as Remicade^® (infliximab), Humira^® (adalimumab), Enbrel^® (etanercept), or Simponi^® (golimumab)

Ask your healthcare provider if you are not sure. You should not take CIMZIA while you take any of these medicines.

How should I receive CIMZIA?

CIMZIA comes as a lyophilized powder or a solution in a prefilled syringe for injection. If your healthcare provider prescribes the CIMZIA powder, CIMZIA should be injected by a healthcare provider. If your healthcare provider prescribes the prefilled syringe, you will be trained on how to inject CIMZIA. See the booklet called "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 healthcare provider, or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your healthcare provider will tell you how much and how often to inject CIMZIA. Do not use more CIMZIA or inject more often than prescribed.

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, swelling of your ankles or feet, or sudden weight gain.
• Allergic Reactions. Signs of an allergic reaction include a skin rash, swelling or itching of the face, tongue, lips, or throat, 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 healthcare provider should monitor you carefully before and during treatment with CIMZIA to see if you carry the hepatitis B virus in your blood. Tell your healthcare provider if you have any of the following symptoms:
  • feel unwell
  • skin or eyes look yellow
  • tiredness (fatigue)
  • poor appetite or vomiting
  • pain on the right side of your stomach (abdomen)
• New or worsening nervous system problems, such as multiple sclerosis (MS), Guillain-Barre syndrome, seizures, or inflammation of the nerves of the eyes. Symptoms may include:
  • dizziness
  • numbness or tingling
  • problems with your vision
  • weakness in your arms or legs
• 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 does not 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 healthcare provider right away if you have any side effects listed above.

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

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all of the possible side effects of CIMZIA. For more information, ask your healthcare provider or pharmacist.

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.

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