This medication is used to treat certain bowel diseases (Crohn's disease, ulcerative colitis). Some brands may also be used to treat a certain type of arthritis (rheumatoid arthritis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease.

This monograph is about the following infliximab products: infliximab, infliximab-dyyb.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using infliximab and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin as directed by your doctor, usually once every 2 weeks. The injection is given in the abdomen, thigh, or upper arm. The dosage is based on your medical condition and response to treatment.

Take the medication out of the refrigerator at least 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). Do not shake the medication. 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 tender, damaged, bruised, or scarred. 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.

Injection site redness, pain, itching, or swelling may occur. Headache, upset stomach, back pain, diarrhea, tiredness, or dizziness may also 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:

• joint/muscle pain
• easy bruising/bleeding
• seizures
• confusion
• muscle weakness
• numbness/tingling of arms/legs
• butterfly-shaped facial rash
• pain/redness/swelling of arms or legs
• 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

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 infliximab, tell your doctor or pharmacist if you are allergic to it; 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)
• cancer (such as breast cancer, skin cancer, lymphoma)
• a certain lung disorder (chronic obstructive pulmonary disease-COPD)
• liver problems (such as hepatitis B)
• light treatment for psoriasis (phototherapy)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Infliximab 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 doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using infliximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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

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. 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 drug may pass into breast milk, but it is unlikely to harm a nursing infant. 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 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)

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, Pap smear) should 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 packaging to protect from light. Some brands of this medication may also be stored at room temperature if needed. Check the product package for storage instructions or ask your pharmacist. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 28 days. 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).