SIDE EFFECTS: See also Warning section. Headache, stomach pain, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Symptoms of an infusion reaction that may occur during infliximab-dyyb treatment include pain/swelling at the injection site, shortness of breath, flushing, chills, fever, headache, and rash. If you have any of these symptoms, your healthcare professional may need to adjust/stop your infusion and treat your symptoms. Remember that your doctor has prescribed this medication because he or she 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: joint/muscle pain, easy bruising/bleeding, vision changes, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, chest pain, pain/redness/swelling of arms or legs, fast/slow/irregular heartbeat, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Tell your doctor right away if you develop signs of infection while using this drug, such as: cough/sore throat that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush). This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: extreme tiredness, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. 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, difficulty swallowing. 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.

PRECAUTIONS: Before using infliximab-dyyb, tell your doctor or pharmacist if you are allergic to it; or to infliximab or infliximab-abda; or to mouse proteins; or if you have any other allergies. This product may contain inactive ingredients, 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: tuberculosis (previous infection or positive skin test), past/recent/current infections (such as cold sores, valley fever), heart disease (such as heart failure), blood/bone marrow disorder (such as leukopenia, thrombocytopenia), nervous system disorder (such as numbness/tingling, seizures, multiple sclerosis), history of cancer (such as breast cancer, skin cancer, lymphoma), a certain lung disorder (chronic obstructive pulmonary disease-COPD), liver disease (such as hepatitis B), light treatment for psoriasis (phototherapy). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Infliximab-dyyb can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Call your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Older adults may be more sensitive to the side effects of this drug, especially risk for infections. During pregnancy, this medication should be used only when clearly needed. 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. It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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 are: other drugs that weaken the immune system/increase the risk of infection (such as abatacept, anakinra), treatment with weakened bacteria/viruses (such as live vaccines, BCG for bladder cancer). Infliximab-dyyb is very similar to infliximab and infliximab-abda. Do not use infliximab or infliximab-abda while using infliximab-dyyb.

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.