Certolizumab Prefilled Syringes

• If you have an allergy to certolizumab pegol or any other part of this medicine (certolizumab prefilled syringes).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an infection.
• If you are taking any of these drugs: Abatacept, adalimumab, anakinra, etanercept, golimumab, infliximab, natalizumab, rituximab, or tocilizumab.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

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 this medicine (certolizumab prefilled syringes) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use with this medicine (certolizumab prefilled syringes) 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 this medicine. 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 this medicine (certolizumab prefilled syringes).
• Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
• 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 this medicine. These cases have been deadly. Most of the time, these cases happened in teenagers or young adults. Most of these patients were using this medicine (certolizumab prefilled syringes) 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.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (certolizumab prefilled syringes) while you are pregnant.
• If you used this medicine when you were pregnant, tell your baby's doctor.

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 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 low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• 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.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Very bad headache.
• Any unexplained bruising or bleeding.
• A big weight loss.
• Night sweats.
• Very bad irritation where the shot was given.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Lump in the armpit, groin, or neck.
• Feeling very tired or weak.
• Pale skin.
• Not able to pass urine or change in how much urine is passed.
• A skin lump or growth.
• Change in color or size of a mole.
• Heart failure has happened with this medicine (certolizumab prefilled syringes), 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.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have 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.

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.