Certolizumab Injection

IMPORTANT WARNING:

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 decrease the activity of the immune system.

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). Some teenage and young adult males who took certolizumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with certolizumab or a similar medication along with another medication called azathioprine or 6-mercaptopurine. Adults who use certolizumab injection may also be at greater risk of developing certain types of cancer, including skin cancer. Tell your doctor if you or your child have ever had any type of cancer. If you or your child develop any of these symptoms during treatment, call your doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; easy bruising or bleeding; a new skin lesion or bump; or a change in the size or color of a mole. Your doctor will also check your skin for any changes during your treatment. Talk to your doctor about the risks of using certolizumab injection

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 (https://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 medicine prescribed?

Certolizumab injection is used to treat 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 in adults. Certolizumab injection is also used to treat 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, and 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) in adults. Certolizumab injection is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age or older. 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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 prefilled 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 or polyarticular juvenile idiopathic arthritis, 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.

If you are using a prefilled syringe that has been refrigerated, place it on a flat surface and allow it warm to room temperature for about 30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Do not shake the prefilled syringe that contains certolizumab.

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 prefilled 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.

What SPECIAL PRECAUTIONS should I follow?

Before using certolizumab injection,

• tell your doctor and pharmacist if you are allergic to certolizumab injection; any other medications, latex or rubber, or any of the ingredients in certolizumab injection. Ask your pharmacist or check the medication guide for a list of the ingredients. If you will be using the prefilled syringe, tell your doctor if you or the person who will be injecting the medication is allergic to latex.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving certolizumab injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had a disease that affects your nervous system, such as multiple sclerosis (MS; a disease in which the nerves do not function properly causing weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage) or optic neuritis (inflammation of the nerve that sends messages from the eye to the brain); numbness, burning, or tingling in any part of your body; seizures; heart failure; any type of cancer; or bleeding problems or diseases that affect your blood.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using certolizumab injection, call your doctor.

• ask your doctor whether you should receive any vaccinations before you begin your treatment with certolizumab injection. If possible, all vaccinations for children should be brought up to date before beginning treatment. Do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Certolizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, pain, or swelling at the site of injection
• headache
• back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• shortness of breath
• difficulty swallowing or breathing
• chest pain
• sudden weight gain
• hives
• hot flashes
• dizziness or fainting
• rash, especially on the cheeks or arms that worsens in the sun
• unusual bruising or bleeding
• pale skin
• blistering skin
• extreme tiredness
• numbness or tingling
• problems with vision
• weakness in the arms or legs
• joint pain
• loss of appetite
• red scaly patches and/or pus-filled bumps on the skin

Certolizumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep the vials and prefilled syringes in the original carton it came in to protect them from light and out of reach of children. Store certolizumab injection in the refrigerator and do not freeze. When necessary, prefilled syringes can be stored at room temperature for up to 7 days. Discard syringes after 7 days at room temperature. Do not place prefilled syringes stored at room temperature back into the refrigerator.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to certolizumab injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using certolizumab injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.