Certolizumab Pegol (ser-toe-LIZ-oo-mab PEG-ol)

Treats rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, Crohn disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis.

Brand Name(s):

Cimzia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach or upper thighs.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is available in 2 forms. A vial and prefilled syringe.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm this medicine in any other way.
  • Check the liquid in the prefilled syringe. It should be clear and colorless or yellow. Do not use the medicine if it is cloudy, discolored, or has particles in it.
  • Remove the plastic ring needle cap by pulling straight up. Do not touch the needle.
  • Gently pinch the skin. With a quick dart-like motion, insert the needle into your skin at about a 45 degree angle. Slowly push the plunger all the way down until the syringe is empty.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep your medicine in its original package until you are ready to use it. You may also store the prefilled syringe at room temperature for up to 7 days. Do not put it back in the refrigerator once stored at room temperature. Throw away any unused medicine after 7 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how certolizumab works. Tell your doctor if you are also using abatacept, adalimumab, anakinra, etanercept, methotrexate, natalizumab, rituximab, or a steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, or prednisone).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, cancer, congestive heart failure, blood or bone marrow problems, or any type of infection (including hepatitis B or tuberculosis). Tell your doctor if you have a history of Guillain-Barré syndrome, multiple sclerosis, or a similar nervous system problem. Also tell your doctor if you have a latex allergy.
• This medicine may cause the following problems:
  • Increased risk of infection (including bacteria, virus, or fungus infections)
  • Increased risk of cancer (including lymphoma, leukemia, or skin cancer)
  • New or worsening heart failure
  • Lupus-like syndrome
• You will need a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody or cloudy urine, painful urination
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Joint pain, rash on the cheeks or arms that is sensitive to the sun
• Seizure, vision problems, numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Swollen lymph glands in your neck, armpits, or groin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Redness, pain, or swelling where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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