Certolizumab Pegol Injection (CERTOLIZUMAB - INJECTION)

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

The liquid should be clear or light yellow.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Store new medicine in the refrigerator until you are ready to use it. Do not allow them to freeze.

Keep the medicine in its original container.

Protect medicine from light.

Take the medicine out of the refrigerator about 30 minutes before use to warm to room temperature.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Never use any medicine that has expired.

If your dose is 2 syringes or injections, inject each in 2 different locations.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Tell your doctor if you have ever had an allergic reaction to latex.

It may take several weeks for this medicine to fully work.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

This medicine passes into breast milk. Ask your doctor before breastfeeding.

Ask your doctor, nurse or pharmacist how to safely discard unused medicines, needles and syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• chest pain
• coughing
• fever
• pain, redness, swelling near injection
• pain in the joints
• runny or stuffy nose

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• unusual bruising or discoloration on skin
• confusion
• cough that does not go away
• dizziness
• swelling of the legs, feet, and hands
• fainting
• fever or chills
• numbness or tingling in hands and feet
• severe or persistent headache
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• eye pain or swelling
• butterfly-shaped rash on nose and cheeks
• seizures
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• sore throat
• light colored stool
• sweating at night
• yeast infection of mouth
• difficulty or discomfort urinating
• vaginal itching or yeast infection
• blurring or changes of vision
• vomiting

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.