Important Safety Information | Prescribing Information | Medication Guide

Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients. 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 in 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 section "Patient Instructions for Use" at the end of the Medication Guide 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.

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.

Laughter and Community—Two Keys to Life With Crohn's


I feel like a person who's able to do the things that I want to do. I can be more active, I can go more places and I have to worry less about where the bathrooms are.
Share Your Story

Tocomba is a single mother of three children who works full-time as a patient ambassador at a healthcare facility, laughs a lot, leads a very busy life—and has Crohn's disease.

At first, Tocomba says, she lived with uncertainty and discomfort during the year it took for her diagnosis to be confirmed. But through all the difficult times, Tocomba was able to maintain a positive attitude and a willingness to be open with family, friends, and doctors about her experience with Crohn's.

After trying several other Crohn’s treatments, Tocomba now takes CIMZIA. With her symptoms under better control, Tocomba feels “a sense of control” over her illness.

In addition to maintaining a close relationship with her doctor, telling her story helps Tocomba stay focused on the future. When you share your experiences with other people, Tocomba says, you can help them see that “there's a whole Crohn’s community going through a lot of the same things, that there is hope—and help.” Not only has sharing helped Tocomba release the burden of having a chronic illness, it’s also given her an outlet to help other people accept themselves.

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. This is a real patient story. Individual results may vary. Only you and your doctor can determine which treatment option is right for you based on treatment risk and benefits, and individual circumstances.

Taking Control of Crohn's, Taking Control of Life


“With the proper treatment and doing what I need to do to make my health better, I am better able to check off the to do list at the end of the day, I look forward toto starting something new.”
Share Your Story

Jillian, an engineer and college sports fan, sees life as a journey filled with new experiences.

Jillian began experiencing Crohn’s symptoms at age 12, and for several years did not know she had Crohn’s disease. During this time, Jillian felt isolated from her family, friends, and the world around her.

It wasn't until her illness forced her to leave college that Jillian’s life began to change for the better. Rather than focusing on the negative aspects of having a chronic illness, Jillian chose to see her Crohn's diagnosis as an opportunity to take control of her life - and to explore what her life could become.

After trying conventional medications, she found symptom control with CIMZIA. With her symptoms under control and the convenience of her self injection, she gained a sense of freedom and independence. Jillian’s schedule is focused on her work and personal interests, not on her doctor’s appointments.

Whether she’s traveling to college basketball and football games or exploring the waterways of Louisiana, Jillian is able to focus on the future. Instead of letting her Crohn’s control her life, Jillian “focuses on what my husband and I want to do to get back into the routine of just having fun and enjoying life”.

Through sharing her experiences, Jillian hopes to move one step closer to the day when people “can stand up and be proud to have Crohn's, rather than just hide in their bathrooms hoping it goes away.”

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. This is a real patient story. Individual results may vary. Only you and your doctor can determine which treatment option is right for you based on treatment risk and benefits, and individual circumstances.

Open to the Possibilities of Life With Crohn's


I feel it's better to be open about your disease. When you share what's going on, people want to help. They want to be there to support you.
Share Your Story

For Michelle, a Registered Nurse and sports enthusiast, coming to terms with Crohn’s disease was like coming out of hiding.

It all began in 1999 when Michelle was just starting nursing school. Even though she was determined to get her nursing degree and help people in need, Michelle hid her condition, unsure of how to speak about Crohn's with her fellow students or teachers. She didn’t want to be seen as “sick.”

But all that has changed since Michelle has taken control of her life with Crohn’s disease. Getting her symptoms under control has helped Michelle accept herself and open up about her experiences. Michelle discovered that she just needed to give people a chance.

After trying conventional treatments Michelle started on CIMZIA. Before she started CIMZIA, Michelle says she’d forgotten "what it felt like to feel good." With her symptoms under more control and the flexibility of self-injection, Michelle is enjoying a life on–the–go–boating, working out, horseback riding, and more.

And what’s more, Michelle's successes have helped her see what’s possible in a life with Crohn’s: “I looked at what I could become, and I stuck to my goals. I didn’t let Crohn’s keep me down.”

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. This is a real patient story. Individual results may vary. Only you and your doctor can determine which treatment option is right for you based on treatment risk and benefits, and individual circumstances.

Crohn's Education for an Educator


Crohn's is not the end of the world, and it doesn't have to mean you can't be who you want to be. You can do almost anything. I'm proof of that. CIMZIA has helped me be who I want to be. I'm teaching. I'm tubing down rivers and camping. I'm doing what I want to do. CIMZIA has controlled my symptoms enough to let me have the time to be me.
Share Your Story

As a middle school teacher, Kathy imparts life lessons to her students every day. But one of the most important lessons she's learned–self–acceptance–came from an unlikely teacher: Crohn’s disease.

Kathy's lesson began when she was a junior in high school and first experienced Crohn’s symptoms. While she struggled to understand what was going on and tried to find an empathetic doctor, Kathy did everything she could to hide her Crohn’s.

In fact, even though she was valedictorian of her class, Kathy chose not to give a speech on graduation day. She just couldn't stand up in front of her classmates for fear she’d have to run to the bathroom. Kathy's decisions about life—even her choice of college—were based on what would be convenient for her Crohn’s.

After trying conventional treatments Kathy started on CIMZIA. All that changed when she was diagnosed and began to receive the appropriate treatment for her and her Crohn’s symptoms. Kathy began to come out of hiding, to learn that she could ask for what she needed, and to advocate for herself and others like her. With the help of CIMZIA, Kathy’s symptoms are now under control.

She stands in front of her class every day as an example of what’s possible once you gain the confidence to go after your dreams. In Kathy’s words, “If I can help one person not do what I did, not hide, not suffer alone …it’s worth it.”

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. This is a real patient story. Individual results may vary. Only you and your doctor can determine which treatment option is right for you based on treatment risk and benefits, and individual circumstances.

Focused on the Finish Line—Not on Crohn's


Now that my symptoms are under control, I can ask myself, ‘What am I going to do next?' I feel like I have endless opportunities.
Share Your Story

For Jordan, an investigator, living with Crohn’s is just another goal to achieve. As Jordan says, “Everyone has an obstacle in life. Crohn's is mine. Figuring that out has really made me appreciate the important things in life and realize I don't want to let anything stop me.”

Jordan has been living with Crohn's since age 14, and at first the diagnosis made him feel isolated from people and the world around him. Balancing the physical and emotional demands of a chronic illness was a struggle, but one that Jordan realized he could overcome.

Jordan soon understood that taking the time to share his experiences with friends and family was the best way to get the support he needed. "The more you talk about Crohn’s,“ Jordan says, "the easier it gets.”

Balancing diet, exercise, and Crohn’s treatment now help Jordan stay focused on his goals. And as for goals, he has many: photographer, artist, marathon runner, just to name a few.

After trying conventional therapies, Jordan tried CIMZIA and experienced improved symptom control. In addition to the improved symptom control that CIMZIA provides, Jordan appreciates the convenience of being able to self–inject. Being able to work his treatment around his schedule—and not the other way around—helps Jordan achieve the balance he's striving for in life.

So what’s Jordan’s best advice for other people with Crohn's who are searching for balance in their lives? Find the best treatment options for you. Talk to your doctors and family. Find a support system to help you through the tough times. And never lose sight of your goals.

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. This is a real patient story. Individual results may vary. Only you and your doctor can determine which treatment option is right for you based on treatment risk and benefits, and individual circumstances.