Brand Name(s):

• Remicade®

Other Name(s):

• Anti-tumor Necrosis Factor-alpha
• Anti-TNF-alpha
• cA2

IMPORTANT WARNING

Infliximab injection may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe viral, bacterial, or fungal infections that may spread throughout 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 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 diabetes or any condition that affects your immune system and if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you do not know if infections are more common in your area. Also tell your doctor if you are taking medications that decrease the activity of the immune system such as abatacept (Orencia); anakinra (Kineret);, methotrexate (Rheumatrex); steroids such as dexamethasone, methylprednisolone (Medrol), prednisolne (Prelone), or prednisone; or tocilizumab (Actemra).

Your doctor will monitor you for signs of infection during and shortly 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: weakness; sweating; difficulty breathing; sore throat; cough; coughing up bloody mucus; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; diarrhea; stomach pain; or other signs of infection.

You may be infected with tuberculosis (TB, a severe lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, infliximab injection may increase the risk that your infection will become more serious and you will 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 infliximab injection. Tell your doctor if you have or have ever had TB, if you have lived in or visited a place 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 fever, or night sweats. 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, teenagers, and young adults who received infliximab injection or similar medications 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 infliximab 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 or ulcerative colitis with infliximab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Tell your child's doctor if your child has ever had any type of cancer. 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. Talk to your child's doctor about the risks of giving infliximab injection to your child.

WHY is this medicine prescribed?

Infliximab 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:

• rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) that is also being treated with methotrexate (Rheumatrex, Trexall).
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults and children 6 years of age or older that has not improved when treated with other medications.
• ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) in adults and children 6 years of age or older that has not improved when treated with other medications.
• ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage).
• psoriasis (a skin disease in which red, scaly patches form on some areas of the body).
• psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin).

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

HOW should this medicine be used?

Infliximab injection comes as a powder to be mixed with sterile water and administered intravenously (into a vein) by a doctor or nurse. It is usually given in a doctor's office once every 2 to 8 weeks, more often in the beginning of your treatment and less often as your treatment continues. It will take about 2 hours for you to receive your entire dose of infliximab injection.

Infliximab injection may cause serious allergic reactions during an infusion and for 2 hours afterward. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. You may be given other medications to treat or prevent reactions to infliximab injection. Tell your doctor or nurse immediately if you experience any of the following symptoms during or shortly after your infusion: hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; flushing; dizziness; fainting; fever; chills; seizures; and chest pain.

Infliximab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well infliximab injection works for you. If you have rheumatoid arthritis or Crohn's disease, your doctor may increase the amount of medication you receive, if needed. If you have Crohn's disease and your condition has not improved after 14 weeks, your doctor may stop treating you with infliximab injection. It is important to tell your doctor how you are feeling during your treatment.

Are there OTHER USES for this medicine?

Infliximab injection is also sometimes used to treat Behcet's syndrome (ulcers in the mouth and on the genitals and inflammation of various parts of the body). Talk to your doctor about the possible risks of using this medication for your condition.

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

What SPECIAL PRECAUTIONS should I follow?

Before using infliximab injection,

• tell your doctor and pharmacist if you are allergic to infliximab injection, any medications made from murine (mouse) proteins, any other medications, or any of the ingredients in infliximab injection. Ask your doctor or pharmacist if you don't know whether a medication you are allergic to is made from murine proteins. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin), cyclosporine (Gengraf, Neoral, Sandimmune), and theophylline (Theochron, Theoloair, Uniphyl). 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 congestive heart failure (condition in which the heart cannot pump enough blood to other parts of the body). Your doctor may tell you not to use infliximab injection.
• tell your doctor if you have ever been treated with phototherapy (a treatment for psoriasis that involves exposing the skin to ultraviolet light) and if you have or have ever had a disease that affects your nervous system, such as multiple sclerosis (MS; loss of coordination, weakness, and numbness due to nerve damage), Guillain-Barre 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; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); any type of cancer; bleeding problems or diseases that affect your blood; or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using infliximab injection, call your doctor. If you use etanercept injection during your pregnancy, be sure to talk to your baby's doctor about this after your baby is born. Your baby may need to receive certain vaccinations later than usual.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using infliximab injection.
• do not have any vaccinations without talking to your doctor. Also tell your doctor if you have recently received a vaccine. If your child will be treated with infliximab injection, talk to his or her doctor about vaccinations that should be given before the start of treatment. If possible, your child should be given all vaccinations needed for children of his or her age before beginning treatment.
• you should know that you may have a delayed allergic reaction 3 to 12 days after you receive infliximab injection. Tell your doctor if you experience any of the following symptoms several days or longer after your treatment: muscle or joint pain; fever; rash; hives; itching; swelling of the hands, face, or lips; difficulty swallowing; sore throat; and headache.

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?

If you miss an appointment to receive an infliximab infusion, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

Your doctor will store the medication in his or her office.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2012.