Certolizumab Injection

Certolizumab injection may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection including severe fungal, bacterial, and viral infections that may spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, hepatitis B (a viral infection that affects the liver), human immunodeficiency virus (HIV), or any condition that affects your immune system, and if you live or have ever lived in areas such as the Ohio and Mississippi River valleys where severe fungal infections are more common. Ask your doctor if you do not know if these infections are common in your area. Tell your doctor if you are taking medications that slow the activity of the immune system such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), methotrexate (Otrexup, Rasuvo, Trexall), natalizumab (Tysabri), rituximab (Rituxan), steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone), and prednisone (Rayos), and tocilizumab (Actemra).

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: sore throat; cough; coughing up bloody mucus; fever; stomach pain; diarrhea; flu-like symptoms; open cuts or sores; weight loss; weakness; sweating; difficulty breathing; difficult, frequent, or painful urination; or other signs of infection.

You may already be infected with tuberculosis (TB; a serious lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, using certolizumab injection may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using certolizumab. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children and teenagers who received medications similar to certolizumab injection developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Children and teenagers should not normally receive certolizumab injection, but in some cases, a doctor may decide that certolizumab injection is the best medication to treat a child’s condition. If certolizumab injection is prescribed for your child, you should talk to your child’s doctor about the risks and benefits of using this medication. If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with certolizumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of using certolizumab injection.

🔔 Why is this medication prescribed?

Certolizumab injection is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following:

• Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications,
• rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function),
• psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin),
• active ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain, swelling, and joint damage) with changes seen on X-ray,
• active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas causing pain and signs of swelling), but without changes seen on X-ray,
• plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light).

Certolizumab injection is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes inflammation.

🔔 How should this medicine be used?

Certolizumab injection comes as a powder to be mixed with sterile water and injected subcutaneously (just under the skin) by a doctor or nurse in a medical office and as a pre-filled syringe that you can inject subcutaneously by yourself at home. When certolizumab injection is used to treat Crohn’s disease, it is usually given every two weeks for the first three doses and then every four weeks for as long as treatment continues. When certolizumab injection is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis, it is usually given every 2 weeks for the first three doses and then every 2 or 4 weeks for as long as treatment continues. When certolizumab injection is used to treat plaque psoriasis, it is usually given every 2 weeks. If you are injecting certolizumab injection yourself, follow the directions on your prescription label carefully. Do not inject more or less certolizumab than prescribed by your doctor.

If you will be injecting certolizumab injection by yourself at home or having a friend or relative inject the medication for you, ask your doctor to show you or the person who will be injecting the medication how to inject it. You and the person who will be injecting the medication should also read the written instructions for use that come with the medication.

Before you open the package containing your medication, check to be sure that the package is not torn, that the tamper-evident seals on the top and bottom of the package are not missing or broken and that the expiration date printed on the package has not passed. After you open the package, look closely at the liquid in the syringe. The liquid should be clear or pale yellow and should not contain large, colored particles. Call your pharmacist, if there are any problems with the package or the syringe. Do not inject the medication.

You may inject certolizumab injection anywhere on your stomach or thighs except your navel (belly button) and the area 2 inches around it. Do not inject the medication into skin that is tender, bruised, red, or hard, or that has scars or stretch marks. Do not inject the medication in the same spot more than once. Choose a new spot at least 1 inch away from a spot that you have used before each time you inject the medication. If your doctor has told you to inject two syringes of certolizumab for each dose, choose a different spot for each injection.

Do not reuse certolizumab pre-filled syringes and do not recap the syringes after use. Discard used syringes in a puncture-resistant container. Ask your pharmacist how to discard the container.

Certolizumab injection may help to control your symptoms, but it will not cure your condition. Do not stop using certolizumab injection without talking to your doctor.