Uses of Cimzia:

• It is used to treat Crohn's disease.
• It is used to treat rheumatoid arthritis.
• It is used to treat psoriatic arthritis.
• It is used to treat ankylosing spondylitis.
• It is used to treat plaque psoriasis.
• It is used to treat spondyloarthritis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Cimzia?

• If you have an allergy to certolizumab pegol or any other part of Cimzia (certolizumab vials).
• If you are allergic to Cimzia (certolizumab vials); any part of Cimzia (certolizumab vials); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you are taking any of these drugs: Abatacept, adalimumab, anakinra, etanercept, golimumab, infliximab, natalizumab, rituximab, or tocilizumab.

This is not a list of all drugs or health problems that interact with Cimzia (certolizumab vials).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cimzia (certolizumab vials) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Cimzia?

• Tell all of your health care providers that you take Cimzia (certolizumab vials). This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have had hepatitis B before or carry the virus, Cimzia (certolizumab vials) can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems. You will be tested for hepatitis B before starting Cimzia (certolizumab vials). You will need to watch for signs of hepatitis while taking Cimzia (certolizumab vials) and for several months after stopping it. Talk with your doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Cimzia (certolizumab vials) may either raise the chance of an infection or make the vaccine not work as well.
• Do not get a weakened bacteria like BCG for bladder cancer while you use Cimzia (certolizumab vials). Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Cimzia (certolizumab vials).
• Have your skin checked as you have been told by your doctor.
• Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
• A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with Cimzia (certolizumab vials). These cases have been deadly. Most of the time, these cases happened in teenagers or young adults. Most of these patients were using Cimzia (certolizumab vials) to treat certain types of bowel problems like Crohn disease and ulcerative colitis. This medicine is not approved for use to treat bowel problems like these. Tell the doctor if you have ever had any type of cancer. Talk with the doctor.
• Heart failure has happened with Cimzia (certolizumab vials), as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
• If you are 65 or older, use Cimzia (certolizumab vials) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If you used Cimzia (certolizumab vials) when you were pregnant, tell your baby's doctor.

How is this medicine (Cimzia) best taken?

Use Cimzia (certolizumab vials) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• If stored in a refrigerator, let Cimzia (certolizumab vials) come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat Cimzia (certolizumab vials).
• This medicine must be mixed with sterile water before using. The sterile water that comes with Cimzia (certolizumab vials) is meant for one use only. Throw away any part of the sterile water that is not used after one use.
• When making, do not shake vial.
• Use right away after mixing or you may store in a refrigerator for up to 24 hours.
• When ready to inject the mixed drug, it should be at room temperature. Do not leave any mixed drug at room temperature for more than 2 hours before using.
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Inject at least 1 inch away from where the last dose was given. If your dose has more than 1 injection, give the injections into 2 different places at least 1 inch apart.
• Do not give into skin within 2 inches of the belly button.
• Throw away any part of the opened vial not used after the shot is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad dizziness or passing out.
• Lump in the armpit, groin, or neck.
• Pale skin.
• Call your doctor right away if you have a swollen gland, night sweats, shortness of breath, or weight loss without trying.
• Unsafe blood cell count problems have happened, like aplastic anemia and a type of low white blood cell count. Tell your doctor right away if you feel very tired or weak, or have a fever, chills, shortness of breath, any unexplained bruising or bleeding, or purple "splotches" on your skin.
• Certain types of skin cancer have happened in people taking Cimzia (certolizumab vials). Call your doctor right away if you have a change in color or size of a mole, or any new or changing skin lump or growth.

What are some other side effects of Cimzia?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Cimzia?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, you may store at room temperature for up to 6 months. Write down the date you take Cimzia (certolizumab vials) out of the refrigerator. If stored at room temperature and not used within 6 months, throw Cimzia (certolizumab vials) away.
• Do not put Cimzia (certolizumab vials) back in the refrigerator after it has been stored at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Cimzia (certolizumab vials) is refilled. If you have any questions about Cimzia (certolizumab vials), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What are the new drugs for the treatment of rheumatoid arthritis (RA)?
• How long does Cimzia take to work?
• What's the difference between Cimzia and Humira?
• Does Cimzia (certolizumab) make you gain weight?
• How and where is the Cimzia injection given?
• Does Cimzia cause hair loss?

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