Cimzia 400 mg/2 mL (200 mg/mL x 2) subcutaneous syringe kit

Generic name:
Certolizumab - injection

Pronunciation
(SER-toe-LIZ-oo-mab)

Brand name(s)
Cimzia

This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Tell your doctor right away if you develop signs of an infection while using this drug, such as sore throat or cough that doesn't go away, fever, chills, night sweats, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

If you are diagnosed with TB, you must first be treated for it before you start certolizumab to prevent a serious TB infection.

Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as fever that doesn't go away, unusual lumps/growths, skin changes, swollen glands, swollen or painful abdomen, unexplained weight loss, or night sweats.

This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis). Some brands may also be used to treat a certain type of spine condition (axial spondyloarthritis) or a certain bowel condition (Crohn's disease). Certolizumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by blocking TNF, a substance made by the body that causes inflammation.

Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using certolizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor. The injection is given in the stomach or thigh area. The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Take the medication out of the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is sore, bruised, red, scaly, or hard. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Cough, sore throat, stuffy/runny nose, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• swollen joints
• rash on nose and cheeks
• eye pain
• vision changes
• dizziness
• numbness/tingling of arms/legs
• seizures
• new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Certolizumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including:

• nausea/vomiting that doesn't stop
• stomach/abdominal pain
• dark urine
• yellowing eyes/skin

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• any current/recent infection (such as HIV, hepatitis B, tuberculosis)
• any infection that keeps coming back
• cuts or open sores
• cancer
• diabetes
• heart failure
• blood/bone marrow disorders
• history of cancer (such as lymphoma)
• brain/nervous system disorders (such as multiple sclerosis, seizures)

Certolizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using certolizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults are more sensitive to the effects of this drug, especially the risk of infections.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies.

This medication passes into breast milk Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• abatacept
• anakinra
• other drugs that weaken the immune system (such as azathioprine, cancer chemotherapy, cyclosporine)

This medication may interfere with certain lab tests (such as aPTT tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function, skin exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original package to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard within the time directed in the product instructions. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.